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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00328627
Registration number
NCT00328627
Ethics application status
Date submitted
19/05/2006
Date registered
22/05/2006
Date last updated
4/04/2013
Titles & IDs
Public title
Efficacy and Safety of Alogliptin Combined With Pioglitazone in Treating Subjects With Type 2 Diabetes Mellitus.
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Scientific title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of the Combination of SYR-322 (SYR110322) and Pioglitazone HCl (ACTOS®), in Subjects With Type 2 Diabetes
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Secondary ID [1]
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2006-000694-30
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Secondary ID [2]
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01-05-TL-322OPI-001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus
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Condition category
Condition code
Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Alogliptin
Treatment: Drugs - Alogliptin placebo
Treatment: Drugs - Pioglitazone
Treatment: Drugs - Pioglitazone placebo
Placebo Comparator: Placebo - Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
Experimental: Alogliptin 12.5 + Placebo - Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
Experimental: Alogliptin 25 + Placebo - Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
Active Comparator: Placebo + Pioglitazone 15 - Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
Experimental: Alogliptin 12.5 + Pioglitazone 15 - Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
Experimental: Alogliptin 25 + Pioglitazone 15 - Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
Active Comparator: Placebo + Pioglitazone 30 - Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Experimental: Alogliptin 12.5 + Pioglitazone 30 - Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Experimental: Alogliptin 25 + Pioglitazone 30 - Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Active Comparator: Placebo + Pioglitazone 45 - Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
Experimental: Alogliptin 12.5 + Pioglitazone 45 - Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
Experimental: Alogliptin 25 + Pioglitazone 45 - Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
Treatment: Drugs: Alogliptin
Alogliptin tablets.
Treatment: Drugs: Alogliptin placebo
Alogliptin placebo-matching tablets.
Treatment: Drugs: Pioglitazone
Pioglitazone tablets.
Treatment: Drugs: Pioglitazone placebo
Pioglitazone placebo-matching tablets.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline to Week 26 in Glycosylated Hemoglobin (HbA1c) (Grouped Analysis)
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Assessment method [1]
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The change from Baseline to Week 26 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound).
The primary analysis compared the groupings (combinations of individual treatment groups) of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone (Pioglitazone Alone).
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Timepoint [1]
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Baseline and Week 26
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Primary outcome [2]
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Change From Baseline to Week 26 in HbA1c
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Assessment method [2]
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The change from Baseline to Week 26 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound).
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Timepoint [2]
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Baseline and Week 26
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Secondary outcome [1]
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Change From Baseline in HbA1c Over Time (Grouped Analysis)
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Assessment method [1]
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The change from Baseline to Weeks 4, 8, 12, 16 and 20 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound).
This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an analysis of covariance (ANCOVA) model with treatment and geographic region as class variables, and baseline metformin dose and HbA1c as continuous covariates.
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Timepoint [1]
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Baseline and Weeks 4, 8, 12, 16 and 20.
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Secondary outcome [2]
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Change From Baseline to Week 4 in HbA1c
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Assessment method [2]
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The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at week 4. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.
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Timepoint [2]
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Baseline and Week 4
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Secondary outcome [3]
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Change From Baseline to Week 8 in HbA1c
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Assessment method [3]
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The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at week 8. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.
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Timepoint [3]
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Baseline and Week 8
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Secondary outcome [4]
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Change From Baseline to Week 12 in HbA1c
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Assessment method [4]
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The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at week 12.
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.
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Timepoint [4]
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Baseline and Week 12
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Secondary outcome [5]
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Change From Baseline to Week 16 in HbA1c
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Assessment method [5]
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The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at week 16. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.
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Timepoint [5]
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Baseline and Week 16
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Secondary outcome [6]
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Change From Baseline to Week 20 in HbA1c
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Assessment method [6]
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The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at week 20.
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.
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Timepoint [6]
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Baseline and Week 20
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Secondary outcome [7]
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Change From Baseline in Fasting Plasma Glucose Over Time (Grouped Analysis)
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Assessment method [7]
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The change from Baseline in fasting plasma glucose was assessed at weeks 1, 2, 4, 8, 12, 16, 20 and 26.
This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates.
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Timepoint [7]
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Baseline and Weeks 1, 2, 4, 8, 12, 16, 20 and 26.
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Secondary outcome [8]
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Change From Baseline to Week 1 in Fasting Plasma Glucose
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Assessment method [8]
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Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates.
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Timepoint [8]
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Baseline and Week 1
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Secondary outcome [9]
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Change From Baseline to Week 2 in Fasting Plasma Glucose
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Assessment method [9]
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Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates.
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Timepoint [9]
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Baseline and Week 2
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Secondary outcome [10]
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Change From Baseline to Week 4 in Fasting Plasma Glucose
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Assessment method [10]
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Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates.
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Timepoint [10]
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Baseline and Week 4
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Secondary outcome [11]
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Change From Baseline to Week 8 in Fasting Plasma Glucose
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Assessment method [11]
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Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates.
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Timepoint [11]
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Baseline and Week 8
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Secondary outcome [12]
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Change From Baseline to Week 12 in Fasting Plasma Glucose
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Assessment method [12]
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Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates.
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Timepoint [12]
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Baseline and Week 12
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Secondary outcome [13]
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Change From Baseline to Week 16 in Fasting Plasma Glucose
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Assessment method [13]
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Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates.
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Timepoint [13]
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Baseline and Week 16
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Secondary outcome [14]
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Change From Baseline to Week 20 in Fasting Plasma Glucose
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Assessment method [14]
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Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates.
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Timepoint [14]
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Baseline and Week 20
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Secondary outcome [15]
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Change From Baseline to Week 26 in Fasting Plasma Glucose
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Assessment method [15]
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Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates.
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Timepoint [15]
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Baseline and Week 26
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Secondary outcome [16]
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Percentage of Participants With Marked Hyperglycemia (Grouped Analysis)
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Assessment method [16]
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Marked hyperglycemia is defined as fasting plasma glucose greater than or equal to 200 mg/dL (11.10 mmol/L).
This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone.
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Timepoint [16]
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From Week 1 to Week 26
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Secondary outcome [17]
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Percentage of Participants With Marked Hyperglycemia
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Assessment method [17]
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Marked hyperglycemia is defined as fasting plasma glucose greater than or equal to 200 mg/dL (11.10 mmol/L).
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Timepoint [17]
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From Week 1 to Week 26
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Secondary outcome [18]
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Percentage of Participants Meeting Rescue Criteria (Grouped Analysis)
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Assessment method [18]
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Rescue was defined as meeting 1 of the following criteria, confirmed by a 2nd sample drawn within 5 days of the first and analyzed by the central laboratory:
After the Week 1 Visit but prior to the Week 4 Visit: a single fasting plasma glucose =300 mg/dL;
From the Week 4 Visit but prior to the Week 8 Visit: a single fasting plasma glucose =275 mg/dL;
From the Week 8 Visit but prior to the Week 12 Visit: a single fasting plasma glucose =250 mg/dL;
From the Week 12 Visit through the End-of-Treatment Visit: HbA1c =8.5% and =0.5% reduction in HbA1c as compared with Baseline HbA1c.
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Timepoint [18]
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From Week 1 to Week 26.
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Secondary outcome [19]
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Percentage of Participants Meeting Rescue Criteria
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Assessment method [19]
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Rescue was defined as meeting 1 of the following criteria, confirmed by a 2nd sample drawn within 5 days of the first and analyzed by the central laboratory:
After the Week 1 Visit but prior to the Week 4 Visit: a single fasting plasma glucose =300 mg/dL;
From the Week 4 Visit but prior to the Week 8 Visit: a single fasting plasma glucose =275 mg/dL;
From the Week 8 Visit but prior to the Week 12 Visit: a single fasting plasma glucose =250 mg/dL;
From the Week 12 Visit through the End-of-Treatment Visit: HbA1c =8.5% and =0.5% reduction in HbA1c as compared with Baseline HbA1c.
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Timepoint [19]
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From Week 1 to Week 26
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Secondary outcome [20]
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Percentage of Participants With Glycosylated Hemoglobin = 6.5% (Grouped Analysis)
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Assessment method [20]
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Clinical response at Week 26 was assessed by the percentage of participants with HbA1c less than or equal to 6.5%.
This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone.
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Timepoint [20]
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Week 26
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Secondary outcome [21]
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Percentage of Participants With Glycosylated Hemoglobin = 6.5%
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Assessment method [21]
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Clinical response at Week 26 was assessed by the percentage of participants with HbA1c less than or equal to 6.5%.
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Timepoint [21]
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Week 26
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Secondary outcome [22]
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Percentage of Participants With Glycosylated Hemoglobin = 7.0% (Grouped Analysis)
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Assessment method [22]
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Clinical response at Week 26 was assessed by the percentage of participants with HbA1c less than or equal to 7%.
This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone.
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Timepoint [22]
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Week 26
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Secondary outcome [23]
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Percentage of Participants With Glycosylated Hemoglobin = 7%
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Assessment method [23]
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Clinical response at Week 26 was assessed by the percentage of participants with HbA1c less than or equal to 7%.
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Timepoint [23]
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Week 26
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Secondary outcome [24]
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Percentage of Participants With Glycosylated Hemoglobin = 7.5% (Grouped Analysis)
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Assessment method [24]
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Clinical response at Week 26 was assessed by the percentage of participants with HbA1c less than or equal to 7.5%.
This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone.
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Timepoint [24]
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Week 26
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Secondary outcome [25]
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Percentage of Participants With Glycosylated Hemoglobin = 7.5%
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Assessment method [25]
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Clinical response at Week 26 was assessed by the percentage of participants with HbA1c less than or equal to 7.5%.
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Timepoint [25]
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Week 26
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Secondary outcome [26]
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Percentage of Participants With a Decrease in Glycosylated Hemoglobin = 0.5% (Grouped Analysis)
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Assessment method [26]
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Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 0.5%.
This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone.
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Timepoint [26]
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Baseline and Week 26
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Secondary outcome [27]
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Percentage of Participants With a Decrease in Glycosylated Hemoglobin = 0.5%
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Assessment method [27]
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Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 0.5%.
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Timepoint [27]
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Baseline and Week 26
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Secondary outcome [28]
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Percentage of Participants With a Decrease in Glycosylated Hemoglobin = 1% (Grouped Analysis)
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Assessment method [28]
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Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1%.
This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone.
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Timepoint [28]
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Baseline and Week 26
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Secondary outcome [29]
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Percentage of Participants With a Decrease in Glycosylated Hemoglobin = 1%
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Assessment method [29]
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Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1%.
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Timepoint [29]
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Baseline and Week 26
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Secondary outcome [30]
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Percentage of Participants With a Decrease in Glycosylated Hemoglobin = 1.5% (Grouped Analysis)
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Assessment method [30]
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Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1.5%.
This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone.
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Timepoint [30]
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Baseline and Week 26
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Secondary outcome [31]
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Percentage of Participants With a Decrease in Glycosylated Hemoglobin = 1.5%
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Assessment method [31]
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Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1.5%.
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Timepoint [31]
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Baseline and Week 26
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Secondary outcome [32]
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Percentage of Participants With a Decrease in Glycosylated Hemoglobin = 2.0% (Grouped Analysis)
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Assessment method [32]
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Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 2.0%.
This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone.
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Timepoint [32]
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Baseline and Week 26.
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Secondary outcome [33]
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Percentage of Participants With a Decrease in Glycosylated Hemoglobin = 2%
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Assessment method [33]
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Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 2%.
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Timepoint [33]
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Baseline and Week 26
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Secondary outcome [34]
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0
Change From Baseline in Fasting Proinsulin Over Time (Grouped Analysis)
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Assessment method [34]
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Proinsulin is a precursor to insulin, and was measured as an indicator of pancreatic function. The change from Baseline in fasting proinsulin was assessed at Weeks 4, 8, 12, 16, 20 and 26.
This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and proinsulin as continuous covariates.
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Timepoint [34]
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Baseline and Weeks 4, 8, 12, 16, 20 and 26.
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Secondary outcome [35]
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Change From Baseline to Week 4 in Fasting Proinsulin
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Assessment method [35]
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Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin as continuous covariates.
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Timepoint [35]
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Baseline and Week 4
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Secondary outcome [36]
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Change From Baseline to Week 8 in Fasting Proinsulin
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Assessment method [36]
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0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin as continuous covariates.
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Timepoint [36]
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Baseline and Week 8
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Secondary outcome [37]
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Change From Baseline to Week 12 in Fasting Proinsulin
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Assessment method [37]
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Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin as continuous covariates.
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Timepoint [37]
0
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Baseline and Week 12
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Secondary outcome [38]
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Change From Baseline to Week 16 in Fasting Proinsulin
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Assessment method [38]
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0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin as continuous covariates.
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Timepoint [38]
0
0
Baseline and Week 16
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Secondary outcome [39]
0
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Change From Baseline to Week 20 in Fasting Proinsulin
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Assessment method [39]
0
0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin as continuous covariates.
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Timepoint [39]
0
0
Baseline and Week 20
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Secondary outcome [40]
0
0
Change From Baseline to Week 26 in Fasting Proinsulin
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Assessment method [40]
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0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin as continuous covariates.
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Timepoint [40]
0
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Baseline and Week 26
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Secondary outcome [41]
0
0
Change From Baseline in Insulin Over Time (Grouped Analysis)
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Assessment method [41]
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0
The change from Baseline in fasting insulin was assessed at Weeks 4, 8, 12, 16, 20 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates.
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Timepoint [41]
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0
Baseline and Weeks 4, 8, 12, 16, 20 and 26.
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Secondary outcome [42]
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0
Change From Baseline to Week 4 in Insulin Levels
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Assessment method [42]
0
0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates.
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Timepoint [42]
0
0
Baseline and Week 4
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Secondary outcome [43]
0
0
Change From Baseline to Week 8 in Insulin Levels
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Assessment method [43]
0
0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates.
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Timepoint [43]
0
0
Baseline and Week 8
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Secondary outcome [44]
0
0
Change From Baseline to Week 12 in Insulin Levels
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Assessment method [44]
0
0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates.
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Timepoint [44]
0
0
Baseline and Week 12
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Secondary outcome [45]
0
0
Change From Baseline to Week 16 in Insulin Levels
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Assessment method [45]
0
0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates.
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Timepoint [45]
0
0
Baseline and Week 16
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Secondary outcome [46]
0
0
Change From Baseline to Week 20 in Insulin Levels
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Assessment method [46]
0
0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates.
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Timepoint [46]
0
0
Baseline and Week 20
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Secondary outcome [47]
0
0
Change From Baseline to Week 26 in Insulin Levels
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Assessment method [47]
0
0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates.
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Timepoint [47]
0
0
Baseline and Week 26
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Secondary outcome [48]
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0
Change From Baseline in Proinsulin/Insulin Ratio Over Time (Grouped Analysis)
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Assessment method [48]
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0
The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (µIU/mL) at weeks 4, 8, 12, 16, 20 and 26 relative to the Baseline value.
This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates.
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Timepoint [48]
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0
Baseline and Weeks 4, 8, 12, 16, 20 and 26.
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Secondary outcome [49]
0
0
Change From Baseline to Week 4 in Proinsulin/Insulin Ratio
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Assessment method [49]
0
0
The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (µIU/mL).
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates.
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Timepoint [49]
0
0
Baseline and Week 4
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Secondary outcome [50]
0
0
Change From Baseline to Week 8 in Proinsulin/Insulin Ratio
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Assessment method [50]
0
0
The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (µIU/mL).
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates.
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Timepoint [50]
0
0
Baseline and Week 8
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Secondary outcome [51]
0
0
Change From Baseline to Week 12 in Proinsulin/Insulin Ratio
Query!
Assessment method [51]
0
0
The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (µIU/mL).
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates.
Query!
Timepoint [51]
0
0
Baseline and Week 12
Query!
Secondary outcome [52]
0
0
Change From Baseline to Week 16 in Proinsulin/Insulin Ratio
Query!
Assessment method [52]
0
0
The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (µIU/mL).
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates.
Query!
Timepoint [52]
0
0
Baseline and Week 16
Query!
Secondary outcome [53]
0
0
Change From Baseline to Week 20 in Proinsulin/Insulin Ratio
Query!
Assessment method [53]
0
0
The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (µIU/mL).
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates.
Query!
Timepoint [53]
0
0
Baseline and Week 20
Query!
Secondary outcome [54]
0
0
Change From Baseline to Week 26 in Proinsulin/Insulin Ratio
Query!
Assessment method [54]
0
0
The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (µIU/mL).
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates.
Query!
Timepoint [54]
0
0
Baseline and Week 26
Query!
Secondary outcome [55]
0
0
Change From Baseline in C-peptide Over Time (Grouped Analysis)
Query!
Assessment method [55]
0
0
C-peptide is a byproduct created when the hormone insulin is produced and is measured by a blood test. Change from Baseline was assessed at Weeks 4, 8, 12, 16, 20 and 26.
This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates.
Query!
Timepoint [55]
0
0
Baseline and Weeks 4, 8, 12, 16, 20 and 26.
Query!
Secondary outcome [56]
0
0
Change From Baseline to Week 4 in C-peptide Levels
Query!
Assessment method [56]
0
0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates.
Query!
Timepoint [56]
0
0
Baseline and Week 4
Query!
Secondary outcome [57]
0
0
Change From Baseline to Week 8 in C-peptide Levels
Query!
Assessment method [57]
0
0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates.
Query!
Timepoint [57]
0
0
Baseline and Week 8
Query!
Secondary outcome [58]
0
0
Change From Baseline to Week 12 in C-peptide Levels
Query!
Assessment method [58]
0
0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates.
Query!
Timepoint [58]
0
0
Baseline and Week 12
Query!
Secondary outcome [59]
0
0
Change From Baseline to Week 16 in C-peptide Levels
Query!
Assessment method [59]
0
0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates.
Query!
Timepoint [59]
0
0
Baseline and Week 16
Query!
Secondary outcome [60]
0
0
Change From Baseline to Week 20 in C-peptide Levels
Query!
Assessment method [60]
0
0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates.
Query!
Timepoint [60]
0
0
Baseline and Week 20
Query!
Secondary outcome [61]
0
0
Change From Baseline to Week 26 in C-peptide Levels
Query!
Assessment method [61]
0
0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates.
Query!
Timepoint [61]
0
0
Baseline and Week 26
Query!
Secondary outcome [62]
0
0
Change From Baseline in Total Cholesterol Over Time (Grouped Analysis)
Query!
Assessment method [62]
0
0
Change from Baseline in total cholesterol was assessed at Weeks 4, 8, 12, 16, 20 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates.
Query!
Timepoint [62]
0
0
Baseline and Weeks 4, 8, 12, 16, 20 and 26.
Query!
Secondary outcome [63]
0
0
Change From Baseline to Week 4 in Total Cholesterol Levels
Query!
Assessment method [63]
0
0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates.
Query!
Timepoint [63]
0
0
Baseline and Week 4
Query!
Secondary outcome [64]
0
0
Change From Baseline to Week 8 in Total Cholesterol Levels
Query!
Assessment method [64]
0
0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates.
Query!
Timepoint [64]
0
0
Baseline and Week 8
Query!
Secondary outcome [65]
0
0
Change From Baseline to Week 12 in Total Cholesterol Levels
Query!
Assessment method [65]
0
0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates.
Query!
Timepoint [65]
0
0
Baseline and Week 12
Query!
Secondary outcome [66]
0
0
Change From Baseline to Week 16 in Total Cholesterol Levels
Query!
Assessment method [66]
0
0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates.
Query!
Timepoint [66]
0
0
Baseline and Week 16
Query!
Secondary outcome [67]
0
0
Change From Baseline to Week 20 in Total Cholesterol Levels
Query!
Assessment method [67]
0
0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates.
Query!
Timepoint [67]
0
0
Baseline and Week 20
Query!
Secondary outcome [68]
0
0
Change From Baseline to Week 26 in Total Cholesterol Levels
Query!
Assessment method [68]
0
0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates.
Query!
Timepoint [68]
0
0
Baseline and Week 26
Query!
Secondary outcome [69]
0
0
Change From Baseline in Low-Density Lipoprotein Cholesterol Over Time (Grouped Analysis)
Query!
Assessment method [69]
0
0
Change from Baseline in low-density lipoprotein cholesterol (LDL-C) was assessed at Weeks 4, 8, 12, 16, 20 and 26.
This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates.
Query!
Timepoint [69]
0
0
Baseline and Weeks 4, 8, 12, 16, 20 and 26.
Query!
Secondary outcome [70]
0
0
Change From Baseline to Week 4 in Low-Density Lipoprotein Cholesterol
Query!
Assessment method [70]
0
0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates.
Query!
Timepoint [70]
0
0
Baseline and Week 4
Query!
Secondary outcome [71]
0
0
Change From Baseline to Week 8 in Low-Density Lipoprotein Cholesterol
Query!
Assessment method [71]
0
0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates.
Query!
Timepoint [71]
0
0
Baseline and Week 8
Query!
Secondary outcome [72]
0
0
Change From Baseline to Week 12 in Low-Density Lipoprotein Cholesterol
Query!
Assessment method [72]
0
0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates.
Query!
Timepoint [72]
0
0
Baseline and Week 12
Query!
Secondary outcome [73]
0
0
Change From Baseline to Week 16 in Low-Density Lipoprotein Cholesterol
Query!
Assessment method [73]
0
0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates.
Query!
Timepoint [73]
0
0
Baseline and Week 16
Query!
Secondary outcome [74]
0
0
Change From Baseline to Week 20 in Low-Density Lipoprotein Cholesterol
Query!
Assessment method [74]
0
0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates.
Query!
Timepoint [74]
0
0
Baseline and Week 20
Query!
Secondary outcome [75]
0
0
Change From Baseline to Week 26 in Low-Density Lipoprotein Cholesterol
Query!
Assessment method [75]
0
0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates.
Query!
Timepoint [75]
0
0
Baseline and Week 26
Query!
Secondary outcome [76]
0
0
Change From Baseline in High-Density Lipoprotein Cholesterol Over Time (Grouped Analysis)
Query!
Assessment method [76]
0
0
Change from Baseline in high-density lipoprotein cholesterol (HDL-C) was assessed at Weeks 4, 8, 12, 16, 20 and 26.
This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates.
Query!
Timepoint [76]
0
0
Baseline and Weeks 4, 8, 12, 16, 20 and 26.
Query!
Secondary outcome [77]
0
0
Change From Baseline to Week 4 in High-Density Lipoprotein Cholesterol
Query!
Assessment method [77]
0
0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates.
Query!
Timepoint [77]
0
0
Baseline and Week 4
Query!
Secondary outcome [78]
0
0
Change From Baseline to Week 8 in High-Density Lipoprotein Cholesterol
Query!
Assessment method [78]
0
0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates.
Query!
Timepoint [78]
0
0
Baseline and Week 8
Query!
Secondary outcome [79]
0
0
Change From Baseline to Week 12 in High-Density Lipoprotein Cholesterol
Query!
Assessment method [79]
0
0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates.
Query!
Timepoint [79]
0
0
Baseline and Week 12
Query!
Secondary outcome [80]
0
0
Change From Baseline to Week 16 in High-Density Lipoprotein Cholesterol
Query!
Assessment method [80]
0
0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates.
Query!
Timepoint [80]
0
0
Baseline and Week 16
Query!
Secondary outcome [81]
0
0
Change From Baseline to Week 20 in High-Density Lipoprotein Cholesterol
Query!
Assessment method [81]
0
0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates.
Query!
Timepoint [81]
0
0
Baseline and Week 20
Query!
Secondary outcome [82]
0
0
Change From Baseline to Week 26 in High-Density Lipoprotein Cholesterol
Query!
Assessment method [82]
0
0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates.
Query!
Timepoint [82]
0
0
Baseline and Week 26
Query!
Secondary outcome [83]
0
0
Change From Baseline in Triglycerides Over Time (Grouped Analysis)
Query!
Assessment method [83]
0
0
Change from Baseline in triglycerides was assessed at Weeks 4, 8, 12, 16, 20 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates.
Query!
Timepoint [83]
0
0
Baseline and Weeks 4, 8, 12, 16, 20 and 26.
Query!
Secondary outcome [84]
0
0
Change From Baseline to Week 4 in Triglyceride Levels
Query!
Assessment method [84]
0
0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates.
Query!
Timepoint [84]
0
0
Baseline and Week 4
Query!
Secondary outcome [85]
0
0
Change From Baseline to Week 8 in Triglyceride Levels
Query!
Assessment method [85]
0
0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates.
Query!
Timepoint [85]
0
0
Baseline and Week 8
Query!
Secondary outcome [86]
0
0
Change From Baseline to Week 12 in Triglyceride Levels
Query!
Assessment method [86]
0
0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates.
Query!
Timepoint [86]
0
0
Baseline and Week 12
Query!
Secondary outcome [87]
0
0
Change From Baseline to Week 16 in Triglyceride Levels
Query!
Assessment method [87]
0
0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates.
Query!
Timepoint [87]
0
0
Baseline and Week 16
Query!
Secondary outcome [88]
0
0
Change From Baseline to Week 20 in Triglyceride Levels
Query!
Assessment method [88]
0
0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates.
Query!
Timepoint [88]
0
0
Baseline and Week 20
Query!
Secondary outcome [89]
0
0
Change From Baseline to Week 26 in Triglyceride Levels
Query!
Assessment method [89]
0
0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates.
Query!
Timepoint [89]
0
0
Baseline and Week 26
Query!
Secondary outcome [90]
0
0
Change From Baseline in Free Fatty Acids Over Time (Grouped Analysis)
Query!
Assessment method [90]
0
0
Change from Baseline in free fatty acids (FFA) was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline free fatty acid as continuous covariates.
Query!
Timepoint [90]
0
0
Baseline and Weeks 12 and 26.
Query!
Secondary outcome [91]
0
0
Change From Baseline to Week 12 in Free Fatty Acids
Query!
Assessment method [91]
0
0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline free fatty acid as continuous covariates.
Query!
Timepoint [91]
0
0
Baseline and Week 12
Query!
Secondary outcome [92]
0
0
Change From Baseline to Week 26 in Free Fatty Acids
Query!
Assessment method [92]
0
0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline free fatty acid as continuous covariates.
Query!
Timepoint [92]
0
0
Baseline and Week 26
Query!
Secondary outcome [93]
0
0
Change From Baseline in Plasminogen Activator Inhibitor-1 Over Time (Grouped Analysis)
Query!
Assessment method [93]
0
0
Change from Baseline in plasminogen activator inhibitor-1 (PAI-1) was assessed at Weeks 12 and 26.
This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline PAI-1 as continuous covariates.
Query!
Timepoint [93]
0
0
Baseline and Weeks 12 and 26.
Query!
Secondary outcome [94]
0
0
Change From Baseline to Week 12 in Plasminogen Activator Inhibitor-1
Query!
Assessment method [94]
0
0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline PAI-1 as continuous covariates.
Query!
Timepoint [94]
0
0
Baseline and Week 12
Query!
Secondary outcome [95]
0
0
Change From Baseline to Week 26 in Plasminogen Activator Inhibitor-1
Query!
Assessment method [95]
0
0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline PAI-1 as continuous covariates.
Query!
Timepoint [95]
0
0
Baseline and Week 26
Query!
Secondary outcome [96]
0
0
Change From Baseline in High-sensitivity C-Reactive Protein Over Time (Grouped Analysis)
Query!
Assessment method [96]
0
0
Change from Baseline in high-sensitivity C-Reactive Protein (hsCRP) was assessed at Weeks 12 and 26.
This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline hsCRP as continuous covariates.
Query!
Timepoint [96]
0
0
Baseline and Weeks 12 and 26.
Query!
Secondary outcome [97]
0
0
Change From Baseline to Week 12 in High-sensitivity C-Reactive Protein
Query!
Assessment method [97]
0
0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline hsCRP as continuous covariates.
Query!
Timepoint [97]
0
0
Baseline and Week 12
Query!
Secondary outcome [98]
0
0
Change From Baseline to Week 26 in High-sensitivity C-Reactive Protein
Query!
Assessment method [98]
0
0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline hsCRP as continuous covariates.
Query!
Timepoint [98]
0
0
Baseline and Week 26
Query!
Secondary outcome [99]
0
0
Change From Baseline in Adiponectin Over Time (Grouped Analysis)
Query!
Assessment method [99]
0
0
Change from Baseline in adiponectin was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline adiponectin as continuous covariates.
Query!
Timepoint [99]
0
0
Baseline and Weeks 12 and 26.
Query!
Secondary outcome [100]
0
0
Change From Baseline to Week 12 in Adiponectin
Query!
Assessment method [100]
0
0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline adiponectin as continuous covariates.
Query!
Timepoint [100]
0
0
Baseline and Week 12
Query!
Secondary outcome [101]
0
0
Change From Baseline to Week 26 in Adiponectin
Query!
Assessment method [101]
0
0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline adiponectin as continuous covariates.
Query!
Timepoint [101]
0
0
Baseline and Week 26
Query!
Secondary outcome [102]
0
0
Change From Baseline in Body Weight Over Time (Grouped Analysis)
Query!
Assessment method [102]
0
0
Change from Baseline in body weight was assessed at Weeks 8, 12, 20 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline weight as continuous covariates.
Query!
Timepoint [102]
0
0
Baseline and Weeks 8, 12, 20 and 26.
Query!
Secondary outcome [103]
0
0
Change From Baseline to Week 8 in Body Weight
Query!
Assessment method [103]
0
0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline weight as continuous covariates.
Query!
Timepoint [103]
0
0
Baseline and Week 8
Query!
Secondary outcome [104]
0
0
Change From Baseline to Week 12 in Body Weight
Query!
Assessment method [104]
0
0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline weight as continuous covariates.
Query!
Timepoint [104]
0
0
Baseline and Week 12
Query!
Secondary outcome [105]
0
0
Change From Baseline to Week 20 in Body Weight
Query!
Assessment method [105]
0
0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline weight as continuous covariates.
Query!
Timepoint [105]
0
0
Baseline and Week 20
Query!
Secondary outcome [106]
0
0
Change From Baseline to Week 26 in Body Weight
Query!
Assessment method [106]
0
0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline weight as continuous covariates.
Query!
Timepoint [106]
0
0
Baseline and Week 26
Query!
Secondary outcome [107]
0
0
Change From Baseline in Calculated Homeostatic Model Assessment Insulin Resistance (HOMA IR) (Grouped Analysis)
Query!
Assessment method [107]
0
0
HOMA IR measures insulin resistance based on fasting glucose and insulin measurements:
HOMA IR = fasting plasma insulin (µIU/mL) * fasting plasma glucose (mmol/L) / 22.5.
A higher number indicates a greater insulin resistance. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone.
Least Squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and HOMA-IR as continuous covariates.
Query!
Timepoint [107]
0
0
Baseline and Weeks 12 and 26.
Query!
Secondary outcome [108]
0
0
Change From Baseline to Week 12 in Calculated HOMA Insulin Resistance
Query!
Assessment method [108]
0
0
The Homeostasis Model Assessment of insulin resistance (HOMA IR) measures insulin resistance based on fasting glucose and insulin measurements:
HOMA IR = fasting plasma insulin (µIU/mL) * fasting plasma glucose (mmol/L) / 22.5.
A higher number indicates a greater degree of insulin resistance. Least Squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and HOMA-IR as continuous covariates.
Query!
Timepoint [108]
0
0
Baseline and Week 12
Query!
Secondary outcome [109]
0
0
Change From Baseline to Week 26 in Calculated HOMA Insulin Resistance
Query!
Assessment method [109]
0
0
The Homeostasis Model Assessment of insulin resistance (HOMA IR) measures insulin resistance based on fasting glucose and insulin measurements:
HOMA IR = fasting plasma insulin (µIU/mL) * fasting plasma glucose (mmol/L) / 22.5.
A higher number indicates a greater degree of insulin resistance. Least Squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and HOMA-IR as continuous covariates.
Query!
Timepoint [109]
0
0
Baseline and Week 26
Query!
Secondary outcome [110]
0
0
Change From Baseline in Homeostatic Model Assessment Beta Cell Function (Grouped Analysis)
Query!
Assessment method [110]
0
0
The homeostatic model assessment estimates steady state beta cell function as a percentage of a normal reference population (%B).
HOMA %B = 20 * insulin (µIU/mL) / fasting plasma glucose (mmol/L) - 3.5.
This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HOMA beta cell function as continuous covariates.
Query!
Timepoint [110]
0
0
Baseline and Weeks 12 and 26
Query!
Secondary outcome [111]
0
0
Change From Baseline to Week 12 in Calculated HOMA Beta-cell Function
Query!
Assessment method [111]
0
0
The Homeostasis Model Assessment (HOMA) estimates steady state beta cell function (%B) as a percentage of a normal reference population.
HOMA %B = 20 * insulin (µIU/mL) / fasting plasma glucose (mmol/L) - 3.5. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HOMA beta cell function as continuous covariates.
Query!
Timepoint [111]
0
0
Baseline and Week 12
Query!
Secondary outcome [112]
0
0
Change From Baseline to Week 26 in Calculated HOMA Beta-cell Function
Query!
Assessment method [112]
0
0
The Homeostasis Model Assessment (HOMA) estimates steady state beta cell function (%B) as a percentage of a normal reference population.
HOMA %B = 20 * insulin (µIU/mL) / fasting plasma glucose (mmol/L) - 3.5. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HOMA beta cell function as continuous covariates.
Query!
Timepoint [112]
0
0
Baseline and Week 26
Query!
Secondary outcome [113]
0
0
Change From Baseline in Apolipoprotein A1 Over Time (Grouped Analysis)
Query!
Assessment method [113]
0
0
Change from Baseline in Apolipoprotein A1 was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A1 as continuous covariates.
Query!
Timepoint [113]
0
0
Baseline and Weeks 12 and 26.
Query!
Secondary outcome [114]
0
0
Change From Baseline to Week 12 in Apolipoprotein A1
Query!
Assessment method [114]
0
0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A1 as continuous covariates.
Query!
Timepoint [114]
0
0
Baseline and Week 12
Query!
Secondary outcome [115]
0
0
Change From Baseline to Week 26 in Apolipoprotein A1
Query!
Assessment method [115]
0
0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A1 as continuous covariates.
Query!
Timepoint [115]
0
0
Baseline and Week 26
Query!
Secondary outcome [116]
0
0
Change From Baseline in Apolipoprotein A2 Over Time (Grouped Analysis)
Query!
Assessment method [116]
0
0
Change from Baseline in Apolipoprotein A2 was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A2 as continuous covariates.
Query!
Timepoint [116]
0
0
Baseline and Weeks 12 and 26
Query!
Secondary outcome [117]
0
0
Change From Baseline to Week 12 in Apolipoprotein A2
Query!
Assessment method [117]
0
0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A2 as continuous covariates.
Query!
Timepoint [117]
0
0
Baseline and Week 12
Query!
Secondary outcome [118]
0
0
Change From Baseline to Week 26 in Apolipoprotein A2
Query!
Assessment method [118]
0
0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A2 as continuous covariates.
Query!
Timepoint [118]
0
0
Baseline and Week 26
Query!
Secondary outcome [119]
0
0
Change From Baseline in Apolipoprotein B Over Time (Grouped Analysis)
Query!
Assessment method [119]
0
0
Change from Baseline in Apolipoprotein B was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein B as continuous covariates.
Query!
Timepoint [119]
0
0
Baseline and Weeks 12 and 26
Query!
Secondary outcome [120]
0
0
Change From Baseline to Week 12 in Apolipoprotein B
Query!
Assessment method [120]
0
0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein B as continuous covariates.
Query!
Timepoint [120]
0
0
Baseline and Week 12
Query!
Secondary outcome [121]
0
0
Change From Baseline to Week 26 in Apolipoprotein B
Query!
Assessment method [121]
0
0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein B as continuous covariates.
Query!
Timepoint [121]
0
0
Baseline and Week 26
Query!
Secondary outcome [122]
0
0
Change From Baseline in Apolipoprotein C-III Over Time (Grouped Analysis)
Query!
Assessment method [122]
0
0
Change from Baseline in apolipoprotein C-III was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein C-III as continuous covariates.
Query!
Timepoint [122]
0
0
Baseline and Weeks 12 and 26
Query!
Secondary outcome [123]
0
0
Change From Baseline to Week 12 in Apolipoprotein C-III
Query!
Assessment method [123]
0
0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein C-III as continuous covariates.
Query!
Timepoint [123]
0
0
Baseline and Week 12
Query!
Secondary outcome [124]
0
0
Change From Baseline to Week 26 in Apolipoprotein C-III
Query!
Assessment method [124]
0
0
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein C-III as continuous covariates.
Query!
Timepoint [124]
0
0
Baseline and Week 26
Query!
Secondary outcome [125]
0
0
Change From Baseline in Nuclear Magnetic Resonance Lipid Fractionation Total Triglycerides Over Time (Grouped Analysis)
Query!
Assessment method [125]
0
0
Nuclear Magnetic Resonance (NMR) lipid fractionation was used to assess the change from Baseline in total triglyceride levels at Weeks 12 and 26.
This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR total triglycerides as continuous covariates.
Query!
Timepoint [125]
0
0
Baseline and Weeks 12 and 26.
Query!
Secondary outcome [126]
0
0
Change From Baseline to Week 12 in NMR Lipid Fractionation Total Triglycerides
Query!
Assessment method [126]
0
0
NMR lipid fractionation was used to assess the change from Baseline in total triglyceride levels at Week 12.
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR total triglycerides as continuous covariates.
Query!
Timepoint [126]
0
0
Baseline and Week 12
Query!
Secondary outcome [127]
0
0
Change From Baseline to Week 26 in NMR Lipid Fractionation Total Triglycerides
Query!
Assessment method [127]
0
0
NMR lipid fractionation was used to assess the change from Baseline in total triglyceride levels at Week 26.
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR total triglycerides as continuous covariates.
Query!
Timepoint [127]
0
0
Baseline and Week 26
Query!
Secondary outcome [128]
0
0
Change From Baseline in Very Low Density Lipoprotein (VLDL) / Chylomicron Particles Over Time (Grouped Analysis)
Query!
Assessment method [128]
0
0
The change from Baseline in levels of total VLDL/chylomicron particles and large VLDL/chylomicron particles was assessed by NMR lipid fractionation at Weeks 12 and 26.
This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL/chylomicron particles as continuous covariates.
Query!
Timepoint [128]
0
0
Baseline and Weeks 12 and 26
Query!
Secondary outcome [129]
0
0
Change From Baseline to Week 12 in VLDL / Chylomicron Particles
Query!
Assessment method [129]
0
0
The change from Baseline in levels of total VLDL/chylomicron particles and large VLDL/chylomicron particles was assessed by NMR lipid fractionation.
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL/chylomicron particles as continuous covariates.
Query!
Timepoint [129]
0
0
Baseline and Week 12
Query!
Secondary outcome [130]
0
0
Change From Baseline to Week 26 in VLDL / Chylomicron Particles
Query!
Assessment method [130]
0
0
The change from Baseline in levels of total VLDL/chylomicron particles and large VLDL/chylomicron particles was assessed by NMR lipid fractionation.
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL/chylomicron particles as continuous covariates.
Query!
Timepoint [130]
0
0
Baseline and Week 26
Query!
Secondary outcome [131]
0
0
Change From Baseline in VLDL / Chylomicron Triglycerides Over Time (Grouped Analysis)
Query!
Assessment method [131]
0
0
The change from Baseline in levels of VLDL/chylomicron triglycerides was assessed by NMR lipid fractionation at Weeks 12 and 26.
This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL/chylomicron triglycerides as continuous covariates.
Query!
Timepoint [131]
0
0
Baseline and Weeks 12 and 26
Query!
Secondary outcome [132]
0
0
Change From Baseline to Week 12 in VLDL / Chylomicron Triglycerides
Query!
Assessment method [132]
0
0
The change from Baseline in VLDL/chylomicron triglyceride levels was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL/chylomicron triglycerides as continuous covariates.
Query!
Timepoint [132]
0
0
Baseline and Week 12
Query!
Secondary outcome [133]
0
0
Change From Baseline to Week 26 in VLDL / Chylomicron Triglycerides
Query!
Assessment method [133]
0
0
The change from Baseline in VLDL/chylomicron triglyceride levels was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL/chylomicron triglycerides as continuous covariates.
Query!
Timepoint [133]
0
0
Baseline and Week 26
Query!
Secondary outcome [134]
0
0
Change From Baseline in VLDL Particles Over Time (Grouped Analysis)
Query!
Assessment method [134]
0
0
The change from Baseline in levels of medium VLDL particles and small VLDL particles was assessed by NMR fractionation at Weeks 12 and 26.
This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL particles as continuous covariates.
Query!
Timepoint [134]
0
0
Baseline and Weeks 12 and 26
Query!
Secondary outcome [135]
0
0
Change From Baseline to Week 12 in VLDL Particles
Query!
Assessment method [135]
0
0
The change from Baseline in levels of medium VLDL particles and small VLDL particles was assessed by NMR lipid fractionation.
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL particles as continuous covariates.
Query!
Timepoint [135]
0
0
Baseline and Week 12
Query!
Secondary outcome [136]
0
0
Change From Baseline to Week 26 in VLDL Particles
Query!
Assessment method [136]
0
0
The change from Baseline in levels of medium VLDL particles and small VLDL particles was assessed by NMR lipid fractionation.
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL particles as continuous covariates
Query!
Timepoint [136]
0
0
Baseline and Week 26
Query!
Secondary outcome [137]
0
0
Change From Baseline in Mean VLDL Particle Size Over Time (Grouped Analysis)
Query!
Assessment method [137]
0
0
The change from Baseline in mean VLDL particle size was assessed by NMR lipid fractionation at Weeks 12 and 26.
This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean VLDL particle size as continuous covariates.
Query!
Timepoint [137]
0
0
Baseline and Weeks 12 and 26
Query!
Secondary outcome [138]
0
0
Change From Baseline to Week 12 in Mean VLDL Particle Size
Query!
Assessment method [138]
0
0
The change from Baseline in mean VLDL particle size was assessed by NMR lipid fractionation.
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean VLDL particle size as continuous covariates.
Query!
Timepoint [138]
0
0
Baseline and Week 12
Query!
Secondary outcome [139]
0
0
Change From Baseline to Week 26 in Mean VLDL Particle Size
Query!
Assessment method [139]
0
0
The change from Baseline in mean VLDL particle size was assessed by NMR lipid fractionation.
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean VLDL particle size as continuous covariates.
Query!
Timepoint [139]
0
0
Baseline and Week 26
Query!
Secondary outcome [140]
0
0
Change From Baseline in Intermediate Density Lipoprotein (IDL) Particles Over Time (Grouped Analysis)
Query!
Assessment method [140]
0
0
The change from Baseline in levels of IDL particles was assessed by NMR lipid fractionation at Weeks 12 and 26.
This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR IDL particles as continuous covariates.
Query!
Timepoint [140]
0
0
Baseline and Weeks 12 and 26
Query!
Secondary outcome [141]
0
0
Change From Baseline to Week 12 in IDL Particles
Query!
Assessment method [141]
0
0
The change from Baseline in levels of IDL particles was assessed by NMR lipid fractionation.
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR IDL particles as continuous covariates.
Query!
Timepoint [141]
0
0
Baseline and Week 12
Query!
Secondary outcome [142]
0
0
Change From Baseline to Week 26 in IDL Particles
Query!
Assessment method [142]
0
0
The change from Baseline in levels of IDL particles was assessed by NMR lipid fractionation.
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR IDL particles as continuous covariates.
Query!
Timepoint [142]
0
0
Baseline and Week 26
Query!
Secondary outcome [143]
0
0
Change From Baseline in Low Density Lipoprotein (LDL) Particles Over Time (Grouped Analysis)
Query!
Assessment method [143]
0
0
The change from Baseline in levels of total, large, medium-small, total small and very small LDL particles was assessed by NMR fractionation at Weeks 12 and 26.
This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR LDL particles as continuous covariates.
Query!
Timepoint [143]
0
0
Baseline and Weeks 12 and 26
Query!
Secondary outcome [144]
0
0
Change From Baseline to Week 12 in LDL Particles
Query!
Assessment method [144]
0
0
The change from Baseline in levels of total, large, medium-small, total small and very small LDL particles was assessed by NMR lipid fractionation.
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR LDL particles as continuous covariates.
Query!
Timepoint [144]
0
0
Baseline and Week 12
Query!
Secondary outcome [145]
0
0
Change From Baseline to Week 26 in LDL Particles
Query!
Assessment method [145]
0
0
The change from Baseline in levels of total, large, medium-small, total small and very small LDL particles was assessed by NMR lipid fractionation.
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR LDL particles as continuous covariates.
Query!
Timepoint [145]
0
0
Baseline and Week 26
Query!
Secondary outcome [146]
0
0
Change From Baseline in Mean LDL Particle Size Over Time (Grouped Analysis)
Query!
Assessment method [146]
0
0
The change from Baseline in mean LDL particle size was assessed by NMR lipid fractionation at Weeks 12 and 26.
This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone.
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean LDL particle size as continuous covariates.
Query!
Timepoint [146]
0
0
Baseline and Weeks 12 and 26
Query!
Secondary outcome [147]
0
0
Change From Baseline to Week 12 in Mean LDL Particle Size
Query!
Assessment method [147]
0
0
The change from Baseline in mean LDL particle size was assessed by NMR lipid fractionation.
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean LDL particle size as continuous covariates.
Query!
Timepoint [147]
0
0
Baseline and Week 12
Query!
Secondary outcome [148]
0
0
Change From Baseline to Week 26 in Mean LDL Particle Size
Query!
Assessment method [148]
0
0
The change from Baseline in mean LDL particle size was assessed by NMR lipid fractionation.
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean LDL particle size as continuous covariates.
Query!
Timepoint [148]
0
0
Baseline and Week 26
Query!
Secondary outcome [149]
0
0
Change From Baseline in High Density Lipoprotein (HDL) Particles Over Time (Grouped Analysis)
Query!
Assessment method [149]
0
0
The change from Baseline in levels of total, large, medium and small HDL particles was assessed by NMR fractionation at Weeks 12 and 26.
This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR HDL particles as continuous covariates.
Query!
Timepoint [149]
0
0
Baseline and Weeks 12 and 26.
Query!
Secondary outcome [150]
0
0
Change From Baseline to Week 12 in HDL Particles
Query!
Assessment method [150]
0
0
The change from Baseline in levels of total, large, medium and small HDL particles was assessed by NMR lipid fractionation.
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR HDL particles as continuous covariates.
Query!
Timepoint [150]
0
0
Baseline and Week 12
Query!
Secondary outcome [151]
0
0
Change From Baseline to Week 26 in HDL Particles
Query!
Assessment method [151]
0
0
The change from Baseline in levels of total, large, medium and small HDL particles was assessed by NMR lipid fractionation.
Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR HDL particles as continuous covariates.
Query!
Timepoint [151]
0
0
Baseline and Week 26
Query!
Secondary outcome [152]
0
0
Change From Baseline in Mean HDL Particle Size Over Time (Grouped Analysis)
Query!
Assessment method [152]
0
0
The change from Baseline in mean HDL particle size was assessed by NMR lipid fractionation at Weeks 12 and 26.
This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean HDL particle size as continuous covariates.
Query!
Timepoint [152]
0
0
Baseline and Weeks 12 and 26
Query!
Secondary outcome [153]
0
0
Change From Baseline to Week 12 in Mean HDL Particle Size
Query!
Assessment method [153]
0
0
The change from Baseline in mean HDL particle size was assessed by NMR lipid fractionation. Least squares means are from are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean HDL particle size as continuous covariates.
Query!
Timepoint [153]
0
0
Baseline and Week 12
Query!
Secondary outcome [154]
0
0
Change From Baseline to Week 26 in Mean HDL Particle Size
Query!
Assessment method [154]
0
0
The change from Baseline in mean HDL particle size was assessed by NMR lipid fractionation. Least squares means are from are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean HDL particle size as continuous covariates.
Query!
Timepoint [154]
0
0
Baseline and Week 26
Query!
Eligibility
Key inclusion criteria
- Men or women with a historical diagnosis of type 2 diabetes mellitus who were treated
with metformin greater than or equal to 1500 mg alone but were experiencing inadequate
glycemic control.
- A stable dose of metformin of greater than or equal to 1500 mg or maximum tolerated
dose.
- No treatment with antidiabetic agents other than metformin within the 2 months prior
to Screening.
- A body mass index greater than or equal to 23 kg/m^2 and less than or equal to 45
kg/m^2.
- Fasting C-peptide greater than or equal to 0.8 ng/mL.
- Regular use of other, non-excluded medications was allowed if a stable dose had been
established for at least 4 weeks prior to Screening.
- Systolic blood pressure less than or equal to 160 mmHg and diastolic pressure less
than or equal to 100 mmHg.
- Hemoglobin greater than or equal to 12 g/dL for men and greater than or equal to 10
g/dL for women.
- Alanine aminotransferase less than or equal to 2.5 times the upper limit of normal.
- Serum creatinine less than 1.5 mg/dL for men and less than 1.4 mg/dL for women.
- Thyroid-stimulating hormone level less than or equal to the upper limit of the normal
range and the subject was clinically euthyroid.
- Females of childbearing potential who are sexually active must agree to use adequate
contraception, and can neither be pregnant nor lactating from Screening throughout the
duration of the study.
- Able and willing to monitor their own blood glucose concentrations with a home glucose
monitor.
- No major illness or debility that in the investigator's opinion prohibited the patient
from completing the study.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
80
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Urine albumin/creatinine ratio greater than 113 mg/mmol at Screening.
- A history of cancer, other than squamous cell or basal cell carcinoma of the skin,
that had not been in full remission for at least 5 years prior to Screening.
- A history of laser treatment for proliferative diabetic retinopathy within 6 months
prior to Screening.
- A history of treated diabetic gastroparesis.
- New York Heart Association Class III or IV heart failure regardless of therapy.
- History of coronary angioplasty, coronary stent placement, coronary bypass surgery, or
myocardial infarction within the 6 months prior to Screening.
- History of any hemoglobinopathy.
- History of infection with hepatitis B, hepatitis C or human immunodeficiency virus.
- History of a psychiatric disorder that could have affected the patient's ability to
participate in the study.
- History of angioedema in association with use of angiotensin-converting enzyme
inhibitors or angiotensin-II receptor inhibitors.
- A history of alcohol or substance abuse within 2 years prior to Screening.
- Receipt of any investigational drug within 30 days prior to Screening or a history of
receipt of an investigational antidiabetic drug within 3 months prior to Screening.
- Previous participation in an investigational study of alogliptin.
- Hypersensitive to pioglitazone, alogliptin, or other excipients.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/05/2006
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/03/2008
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
1554
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
- Multiple Cities
Query!
Recruitment postcode(s) [1]
0
0
- Multiple Cities
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Arkansas
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
California
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Colorado
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
District of Columbia
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Florida
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Georgia
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Illinois
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Indiana
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Iowa
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Kentucky
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Louisiana
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Maryland
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Massachusetts
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Michigan
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Missouri
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Nevada
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
New Jersey
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
New York
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
North Carolina
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Ohio
Query!
Country [23]
0
0
United States of America
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Oklahoma
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Texas
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Utah
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Vermont
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Brazil
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Chile
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India
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Ukraine
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Takeda
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Summary
Brief summary
The purpose of this study is to evaluate the safety and efficacy of alogliptin, once daily
(QD), taken in combination with pioglitazone in adults with type 2 diabetes mellitus.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00328627
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Contacts
Principal investigator
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VP Biological Sciences
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Takeda
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00328627
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