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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/NCT00286455
Registration number
NCT00286455
Ethics application status
Date submitted
1/02/2006
Date registered
3/02/2006
Date last updated
3/02/2012
Titles & IDs
Public title
Efficacy and Safety of Alogliptin in Subjects With Type 2 Diabetes
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Scientific title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of SYR110322 (SYR-322) Compared With Placebo in Subjects With Type 2 Diabetes
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Secondary ID [1]
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0
2005-004670-24
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Secondary ID [2]
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SYR-322-PLC-010
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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:
Diabetes Mellitus
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0
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Condition category
Condition code
Metabolic and Endocrine
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0
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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
Treatment: Drugs - Placebo
Experimental: Alogliptin 12.5 mg QD -
Experimental: Alogliptin 25 mg QD -
Placebo Comparator: Placebo QD -
Treatment: Drugs: Alogliptin
Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
Treatment: Drugs: Alogliptin
Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
Treatment: Drugs: Placebo
Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
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Intervention code [1]
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0
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 in Glycosylated Hemoglobin (HbA1c) at Week 26.
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Assessment method [1]
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The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 26 or final visit and glycosylated hemoglobin collected at baseline.
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Timepoint [1]
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Baseline and Week 26.
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Secondary outcome [1]
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0
Change From Baseline in Glycosylated Hemoglobin (Week 4).
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Assessment method [1]
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The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and Glycosylated Hemoglobin collected at baseline.
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Timepoint [1]
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Baseline and Week 4.
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Secondary outcome [2]
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0
Change From Baseline in Glycosylated Hemoglobin (Week 8).
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Assessment method [2]
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The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and Glycosylated Hemoglobin collected at baseline.
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Timepoint [2]
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Baseline and Week 8.
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Secondary outcome [3]
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0
Change From Baseline in Glycosylated Hemoglobin (Week 12).
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Assessment method [3]
0
0
The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and Glycosylated Hemoglobin collected at baseline.
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Timepoint [3]
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Baseline and Week 12.
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Secondary outcome [4]
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0
Change From Baseline in Glycosylated Hemoglobin (Week 16).
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Assessment method [4]
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The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and Glycosylated Hemoglobin collected at baseline.
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Timepoint [4]
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Baseline and Week 16.
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Secondary outcome [5]
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Change From Baseline in Glycosylated Hemoglobin (Week 20).
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Assessment method [5]
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The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and Glycosylated Hemoglobin collected at baseline.
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Timepoint [5]
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Baseline and Week 20.
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Secondary outcome [6]
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Change From Baseline in Fasting Plasma Glucose (Week 1).
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Assessment method [6]
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The change between the value of fasting plasma glucose collected at final visit or week 1 and fasting plasma glucose collected at baseline.
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Timepoint [6]
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0
Baseline and Week 1.
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Secondary outcome [7]
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0
Change From Baseline in Fasting Plasma Glucose (Week 2).
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Assessment method [7]
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The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline.
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Timepoint [7]
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0
Baseline and Week 2.
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Secondary outcome [8]
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0
Change From Baseline in Fasting Plasma Glucose (Week 4).
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Assessment method [8]
0
0
The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline.
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Timepoint [8]
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0
Baseline and Week 4.
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Secondary outcome [9]
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0
Change From Baseline in Fasting Plasma Glucose (Week 8).
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Assessment method [9]
0
0
The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline.
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Timepoint [9]
0
0
Baseline and Week 8.
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Secondary outcome [10]
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0
Change From Baseline in Fasting Plasma Glucose (Week 12).
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Assessment method [10]
0
0
The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline.
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Timepoint [10]
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0
Baseline and Week 12.
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Secondary outcome [11]
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0
Change From Baseline in Fasting Plasma Glucose (Week 16).
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Assessment method [11]
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0
The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline.
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Timepoint [11]
0
0
Baseline and Week 16.
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Secondary outcome [12]
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0
Change From Baseline in Fasting Plasma Glucose (Week 20).
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Assessment method [12]
0
0
The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline.
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Timepoint [12]
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0
Baseline and Week 20.
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Secondary outcome [13]
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0
Change From Baseline in Fasting Plasma Glucose (Week 26).
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Assessment method [13]
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0
The change between the value of fasting plasma glucose collected at week 26 or final visit and fasting plasma glucose collected at baseline.
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Timepoint [13]
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0
Baseline and Week 26.
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Secondary outcome [14]
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0
Number of Participants With Marked Hyperglycemia (Fasting Plasma Glucose = 200 mg Per dL).
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Assessment method [14]
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The number of participants with a fasting plasma glucose value greater than or equal to 200 mg per dL at any measurement time point during the 26 week study.
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Timepoint [14]
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26 Weeks.
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Secondary outcome [15]
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Number of Participants Requiring Rescue.
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Assessment method [15]
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The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 26 week study.
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Timepoint [15]
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26 Weeks.
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Secondary outcome [16]
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0
Change From Baseline in Fasting Proinsulin (Week 4).
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Assessment method [16]
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0
The change between the value of fasting proinsulin collected at week 4 and fasting proinsulin collected at baseline.
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Timepoint [16]
0
0
Baseline and Week 4.
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Secondary outcome [17]
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0
Change From Baseline in Fasting Proinsulin (Week 8).
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Assessment method [17]
0
0
The change between the value of fasting proinsulin collected at week 8 and fasting proinsulin collected at baseline.
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Timepoint [17]
0
0
Baseline and Week 8.
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Secondary outcome [18]
0
0
Change From Baseline in Fasting Proinsulin (Week 12).
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Assessment method [18]
0
0
The change between the value of fasting proinsulin collected at week 12 and fasting proinsulin collected at baseline.
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Timepoint [18]
0
0
Baseline and Week 12.
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Secondary outcome [19]
0
0
Change From Baseline in Fasting Proinsulin (Week 16).
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Assessment method [19]
0
0
The change between the value of fasting proinsulin collected at week 16 and fasting proinsulin collected at baseline.
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Timepoint [19]
0
0
Baseline and Week 16.
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Secondary outcome [20]
0
0
Change From Baseline in Fasting Proinsulin (Week 20).
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Assessment method [20]
0
0
The change between the value of fasting proinsulin collected at week 20 and fasting proinsulin collected at baseline.
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Timepoint [20]
0
0
Baseline and Week 20.
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Secondary outcome [21]
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0
Change From Baseline in Fasting Proinsulin (Week 26).
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Assessment method [21]
0
0
The change between the value of fasting proinsulin collected at week 26 or final visit and fasting proinsulin collected at baseline.
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Timepoint [21]
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0
Baseline and Week 26.
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Secondary outcome [22]
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0
Change From Baseline in Insulin (Week 4).
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Assessment method [22]
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0
The change between the value of insulin collected at week 4 and insulin collected at baseline.
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Timepoint [22]
0
0
Baseline and Week 4.
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Secondary outcome [23]
0
0
Change From Baseline in Insulin (Week 8).
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Assessment method [23]
0
0
The change between the value of insulin collected at week 8 and insulin collected at baseline.
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Timepoint [23]
0
0
Baseline and Week 8.
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Secondary outcome [24]
0
0
Change From Baseline in Insulin (Week 12).
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Assessment method [24]
0
0
The change between the value of insulin collected at week 12 and insulin collected at baseline.
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Timepoint [24]
0
0
Baseline and Week 12.
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Secondary outcome [25]
0
0
Change From Baseline in Insulin (Week 16).
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Assessment method [25]
0
0
The change between the value of insulin collected at week 16 and insulin collected at baseline.
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Timepoint [25]
0
0
Baseline and Week 16.
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Secondary outcome [26]
0
0
Change From Baseline in Insulin (Week 20).
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Assessment method [26]
0
0
The change between the value of insulin collected at week 20 and insulin collected at baseline.
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Timepoint [26]
0
0
Baseline and Week 20.
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Secondary outcome [27]
0
0
Change From Baseline in Insulin (Week 26).
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Assessment method [27]
0
0
The change between the value of insulin collected at week 26 and insulin collected at baseline.
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Timepoint [27]
0
0
Baseline and Week 26.
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Secondary outcome [28]
0
0
Change From Baseline in Proinsulin/Insulin Ratio (Week 4).
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Assessment method [28]
0
0
The change between the ratio value of proinsulin and insulin collected at week 4 and the ratio value of proinsulin and insulin collected at baseline.
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Timepoint [28]
0
0
Baseline and Week 4.
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Secondary outcome [29]
0
0
Change From Baseline in Proinsulin/Insulin Ratio (Week 8).
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Assessment method [29]
0
0
The change between the ratio value of proinsulin and insulin collected at week 8 and the ratio value of proinsulin and insulin collected at baseline.
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Timepoint [29]
0
0
Baseline and Week 8.
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Secondary outcome [30]
0
0
Change From Baseline in Proinsulin/Insulin Ratio (Week 12).
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Assessment method [30]
0
0
The change between the ratio value of proinsulin and insulin collected at week 12 and the ratio value of proinsulin and insulin collected at baseline.
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Timepoint [30]
0
0
Baseline and Week 12.
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Secondary outcome [31]
0
0
Change From Baseline in Proinsulin/Insulin Ratio (Week 16).
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Assessment method [31]
0
0
The change between the ratio value of proinsulin and insulin collected at week 16 and the ratio value of proinsulin and insulin collected at baseline.
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Timepoint [31]
0
0
Baseline and Week 16.
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Secondary outcome [32]
0
0
Change From Baseline in Proinsulin/Insulin Ratio (Week 20).
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Assessment method [32]
0
0
The change between the ratio value of proinsulin and insulin collected at week 20 and the ratio value of proinsulin and insulin collected at baseline.
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Timepoint [32]
0
0
Baseline and Week 20.
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Secondary outcome [33]
0
0
Change From Baseline in Proinsulin/Insulin Ratio (Week 26).
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Assessment method [33]
0
0
The change between the ratio value of proinsulin and insulin collected at week 26 or final visit and the ratio value of proinsulin and insulin collected at baseline.
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Timepoint [33]
0
0
Baseline and Week 26.
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Secondary outcome [34]
0
0
Change From Baseline in C-peptide (Week 4).
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Assessment method [34]
0
0
The change between the value of C-peptide collected at week 4 and C-peptide collected at baseline.
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Timepoint [34]
0
0
Baseline and Week 4.
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Secondary outcome [35]
0
0
Change From Baseline in C-peptide (Week 8).
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Assessment method [35]
0
0
The change between the value of C-peptide collected at week 8 and C-peptide collected at baseline.
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Timepoint [35]
0
0
Baseline and Week 8.
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Secondary outcome [36]
0
0
Change From Baseline in C-peptide (Week 12).
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Assessment method [36]
0
0
The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline.
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Timepoint [36]
0
0
Baseline and Week 12.
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Secondary outcome [37]
0
0
Change From Baseline in C-peptide (Week 16).
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Assessment method [37]
0
0
The change between the value of C-peptide collected at week 16 and C-peptide collected at baseline.
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Timepoint [37]
0
0
Baseline and Week 16.
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Secondary outcome [38]
0
0
Change From Baseline in C-peptide (Week 20).
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Assessment method [38]
0
0
The change between the value of C-peptide collected at week 20 and C-peptide collected at baseline.
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Timepoint [38]
0
0
Baseline and Week 20.
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Secondary outcome [39]
0
0
Change From Baseline in C-peptide (Week 26).
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Assessment method [39]
0
0
The change between the value of C-peptide collected at week 26 or final visit and C-peptide collected at baseline.
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Timepoint [39]
0
0
Baseline and Week 26.
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Secondary outcome [40]
0
0
Number of Participants With Glycosylated Hemoglobin = 6.5%.
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Assessment method [40]
0
0
The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 6.5% during the 26 week study.
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Timepoint [40]
0
0
Baseline and Week 26.
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Secondary outcome [41]
0
0
Number of Participants With Glycosylated Hemoglobin = 7.0%.
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Assessment method [41]
0
0
The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.0% during the 26 week study.
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Timepoint [41]
0
0
Baseline and Week 26.
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Secondary outcome [42]
0
0
Number of Participants With Glycosylated Hemoglobin = 7.5%.
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Assessment method [42]
0
0
The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.5% during the 26 week study.
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Timepoint [42]
0
0
Baseline and Week 26.
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Secondary outcome [43]
0
0
Number of Participants With Glycosylated Hemoglobin Decrease From Baseline = 0.5%.
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Assessment method [43]
0
0
The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 0.5% during the 26 week study.
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Timepoint [43]
0
0
Baseline and Week 26.
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Secondary outcome [44]
0
0
Number of Participants With Glycosylated Hemoglobin Decrease From Baseline = 1.0%.
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Assessment method [44]
0
0
The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.0% during the 26 week study.
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Timepoint [44]
0
0
Baseline and Week 26.
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Secondary outcome [45]
0
0
Number of Participants With Glycosylated Hemoglobin Decrease From Baseline = 1.5%.
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Assessment method [45]
0
0
The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.5% during the 26 week study.
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Timepoint [45]
0
0
Baseline and Week 26.
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Secondary outcome [46]
0
0
Number of Participants With Glycosylated Hemoglobin Decrease From Baseline = 2.0%.
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Assessment method [46]
0
0
The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 2.0% during the 26 week study.
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Timepoint [46]
0
0
Baseline and Week 26.
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Secondary outcome [47]
0
0
Change From Baseline in Body Weight (Week 8).
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Assessment method [47]
0
0
The change between Body Weight measured at week 8 and Body Weight measured at baseline.
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Timepoint [47]
0
0
Baseline and Week 8.
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Secondary outcome [48]
0
0
Change From Baseline in Body Weight (Week 12).
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Assessment method [48]
0
0
The change between Body Weight measured at week 12 and Body Weight measured at baseline.
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Timepoint [48]
0
0
Baseline and Week 12.
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Secondary outcome [49]
0
0
Change From Baseline in Body Weight (Week 20).
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Assessment method [49]
0
0
The change between Body Weight measured at week 20 and Body Weight measured at baseline.
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Timepoint [49]
0
0
Baseline and Week 20.
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Secondary outcome [50]
0
0
Change From Baseline in Body Weight (Week 26).
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Assessment method [50]
0
0
The change between Body Weight measured at week 26 or final visit and Body Weight measured at baseline.
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Timepoint [50]
0
0
Baseline and Week 26.
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Secondary outcome [51]
0
0
Change From Baseline in Glucagon (Week 4).
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Assessment method [51]
0
0
The change between the value of glucagon collected at week 4 and glucagon collected at baseline.
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Timepoint [51]
0
0
Baseline and Week 4.
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Secondary outcome [52]
0
0
Change From Baseline in Glucagon (Week 8).
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Assessment method [52]
0
0
The change between the value of glucagon collected at week 8 and glucagon collected at baseline.
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Timepoint [52]
0
0
Baseline and Week 8.
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Secondary outcome [53]
0
0
Change From Baseline in Glucagon (Week 12).
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Assessment method [53]
0
0
The change between the value of glucagon collected at week 12 and glucagon collected at baseline.
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Timepoint [53]
0
0
Baseline and Week 12.
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Secondary outcome [54]
0
0
Change From Baseline in Glucagon (Week 16).
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Assessment method [54]
0
0
The change between the value of glucagon collected at week 16 and glucagon collected at baseline.
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Timepoint [54]
0
0
Baseline and Week 16.
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Secondary outcome [55]
0
0
Change From Baseline in Glucagon (Week 20).
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Assessment method [55]
0
0
The change between the value of glucagon collected at week 20 and glucagon collected at baseline.
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Timepoint [55]
0
0
Baseline and Week 20.
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Secondary outcome [56]
0
0
Change From Baseline in Glucagon (Week 26).
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Assessment method [56]
0
0
The change between the value of glucagon collected at week 26 or final visit and glucagon collected at baseline.
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Timepoint [56]
0
0
Baseline and Week 26.
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Eligibility
Key inclusion criteria
Inclusion Criteria
- Type 2 diabetes mellitus, experiencing inadequate glycemic control, and are receiving
no current antidiabetic therapy. Subjects will qualify if both of the following
conditions apply:
- Subject has failed treatment with diet and exercise for at least one month prior
to Screening
- Subject has received less than 7 days of any antidiabetic therapy within the 3
months prior to Screening Diagnosis of type 2 diabetes must be based on current
American Diabetes Association criteria.
- Body mass index greater than or equal to 23 kg/m2 and less than or equal to 45 kg/m2
- Fasting C-peptide concentration greater than or equal to 0.8 ng per mL (greater than
or equal to 0.26 nmol per L). (If this screening criterion is not met, the subject
still qualifies if C-peptide greater than or equal to1.5 ng per mL (greater than or
equal to 0.50 nmol per L) after a challenge test.
- Glycosylated hemoglobin concentration between 7.0% and 10.0%, inclusive
- If regular use of other, non-excluded medications, must be on a stable dose for at
least the 4 weeks prior to Screening. However, as needed use of prescription or
over-the-counter medications is allowed at the discretion of the investigator.
- Systolic blood pressure less than or equal to 180 mm Hg and diastolic pressure less
than or equal to 110 mm Hg
- Hemoglobin greater than or equal to 12 g per dL (greater than or equal to 120 gm per
L) for males and greater than or equal to 10 g per dL (greater than or equal to 100 gm
per L) for females
- Alanine aminotransferase less than or equal to 3 times the upper limit of normal
- Serum creatinine less than or equal to 2.0 mg per dL (less than or equal to 17
micromol per L)
- Thyroid-stimulating hormone level less than or equal to the upper limit of the normal
range and the subject is clinically euthyroid
- Neither pregnant (confirmed by laboratory testing in females of childbearing
potential) nor lactating.
- Female subjects of childbearing potential must be practicing adequate contraception.
Adequate contraception must be practiced for the duration of participation in 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 prohibits the subject
from completing the study.
- Able and willing to provide written informed consent.
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Minimum age
18
Years
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Maximum age
80
Years
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Query!
Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion Criteria
- Urine albumin to creatinine ratio of greater than1000 µg per mg (greater than 113 mg
per mol) at Screening. If elevated, the subject may be rescreened within 1 week.
- History of cancer, other than squamous cell or basal cell carcinoma of the skin, that
has not been in full remission for at least 5 years prior to Screening. (A history of
treated cervical intraepithelial neoplasia 1 or cervical intraepithelial neoplasia 2
is allowed).
- History of laser treatment for proliferative diabetic retinopathy within the 6 months
prior to Screening.
- History of treated diabetic gastric paresis.
- New York Heart Association Class III or IV heart failure regardless of therapy.
Currently treated subjects who are stable at Class I or II are candidates for the
study.
- History of coronary angioplasty, coronary stent placement, coronary bypass surgery, or
myocardial infarction within the 6 months prior to Screening.
- History of any hemoglobinopathy that may affect determination of glycosylated
hemoglobin.
- History of infection with hepatitis B, hepatitis C, or human immunodeficiency virus.
- History of a psychiatric disorder that will affect the subject's ability to
participate in the study.
- History of angioedema in association with use of angiotensin-converting enzyme
inhibitors or angiotensin-II receptor inhibitors.
- History of alcohol or substance abuse within the 2 years prior to Screening.
- Receipt of any investigational drug within the 30 days prior to Screening or a history
of receipt of an investigational antidiabetic drug within the 3 months prior to
Screening.
- Prior treatment in an investigational study of alogliptin.
- Excluded Medications
- Treatment with antidiabetic agents (other than study drug following enrollment in
the study) is not allowed within the 3 months prior to Screening and through the
completion of the end-of-treatment/early termination procedures. (Exception: if a
subject has received other antidiabetic therapy for less than 7 days within the 3
months prior to Screening.)
- Treatment with weight-loss drugs, any investigational antidiabetics, or oral or
systemically injected glucocorticoids is not allowed from 3 months prior to
randomization through the completion of the end-of-treatment/early termination
procedures. Inhaled corticosteroids are allowed.
- Subjects are not to take any medications, including over-the-counter products,
without first consulting with the Study Doctor.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Query!
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/07/2007
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Sample size
Target
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Accrual to date
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Final
329
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Recruitment postcode(s) [1]
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Recruitment outside Australia
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United States of America
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State/province [1]
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Alabama
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Arizona
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California
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Colorado
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District of Columbia
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Florida
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State/province [7]
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Hawaii
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Idaho
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Indiana
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State/province [10]
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Maryland
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State/province [11]
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Massachusetts
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Missouri
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State/province [13]
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Nebraska
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New Jersey
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United States of America
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State/province [15]
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North Carolina
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State/province [16]
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Ohio
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Oklahoma
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State/province [18]
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Pennsylvania
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State/province [19]
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South Carolina
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Tennessee
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State/province [21]
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Texas
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State/province [22]
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Vermont
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Argentina
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State/province [23]
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Brazil
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State/province [24]
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Country [25]
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Chile
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State/province [25]
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Country [26]
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Czech Republic
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State/province [26]
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Country [27]
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Dominican Republic
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State/province [27]
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Country [28]
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Germany
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State/province [28]
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Country [29]
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Guatemala
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State/province [29]
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Country [30]
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Hungary
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State/province [30]
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Country [31]
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India
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State/province [31]
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Country [32]
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Mexico
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State/province [32]
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Country [33]
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Netherlands
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State/province [33]
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Country [34]
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New Zealand
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State/province [34]
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Country [35]
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Peru
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State/province [35]
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Country [36]
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Poland
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State/province [36]
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Country [37]
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South Africa
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State/province [37]
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Country [38]
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United Kingdom
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State/province [38]
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Takeda
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily
(QD), in adults with type 2 diabetes.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00286455
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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VP Biological Sciences
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Address
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Takeda
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Country
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Phone
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Fax
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Email
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Contact person for public queries
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00286455
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