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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/NCT00286442
Registration number
NCT00286442
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 Combined With Metformin in Participants 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 SYR110322 (SYR-322) When Used in Combination With Metformin in Subjects With Type 2 Diabetes
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Secondary ID [1]
0
0
2005-004668-22
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Secondary ID [2]
0
0
SYR-322-MET-008
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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
0
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 and metformin
Treatment: Drugs - Alogliptin and metformin
Treatment: Drugs - Metformin
Experimental: Alogliptin 12.5 mg QD -
Experimental: Alogliptin 25 mg QD -
Placebo Comparator: Metformin -
Treatment: Drugs: Alogliptin and metformin
Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
Treatment: Drugs: Alogliptin and metformin
Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
Treatment: Drugs: Metformin
Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
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Intervention code [1]
0
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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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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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]
0
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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]
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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 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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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]
0
0
Baseline and Week 20.
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Secondary outcome [6]
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0
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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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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0
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]
0
0
Baseline and Week 2.
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Secondary outcome [8]
0
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]
0
0
Baseline and Week 4.
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Secondary outcome [9]
0
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]
0
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]
0
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]
0
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]
0
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]
0
0
Baseline and Week 20.
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Secondary outcome [13]
0
0
Change From Baseline in Fasting Plasma Glucose (Week 26).
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Assessment method [13]
0
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]
0
0
Baseline and Week 26.
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Secondary outcome [14]
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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 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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Change From Baseline in Fasting Proinsulin (Week 4).
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Assessment method [16]
0
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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]
0
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]
0
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]
0
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]
0
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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Eligibility
Key inclusion criteria
Inclusion Criteria
- Diagnosis of type 2 diabetes mellitus currently treated with metformin alone but,
experiencing inadequate glycemic control. The participant should have received the
metformin monotherapy for at least the 3 months prior to Screening; and must have a
stable dose of greater than or equal to 1500 mg metformin for at least 8 weeks prior
to randomization. Participants with a maximum tolerated dose that is documented to be
less than 1500 mg of metformin may also be enrolled if this dose has been stable for 8
weeks prior to randomization.
- No treatment with antidiabetic agents other than metformin within the 3 months prior
to Screening. (Exception: if a participant has received other antidiabetic therapy for
less than 7 days within the 3 months prior to Screening.)
- 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. (If this
screening criterion is not met, the participant still qualifies if C-peptide is
greater than or equal to 1.5 ng per mL 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 for males and greater than or equal to
10 g per dL for females
- Alanine aminotransferase less than or equal to 3 time the upper limit of normal
- Serum creatinine less than1.5 mg per dL for males and less than 1.4 mg per dL for
females
- Thyroid-stimulating hormone level less than or equal to the upper limit of the normal
range and the participant is clinically euthyroid.
- Neither pregnant nor lactating.
- Female participants 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
participant 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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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 than 1000 µg per mg at Screening. If
elevated, the participant 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 I or cervical intraepithelial neoplasia II
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 participants 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 participant'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 or metformin is not
allowed within the 3 months prior to Screening and through the completion of the
end-of treatment/early termination procedures.
- 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.
- Participants must be instructed not to take any medications, including
over-the-counter products, without first consulting with the investigator.
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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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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
1/03/2006
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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
1/06/2007
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Sample size
Target
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Accrual to date
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Final
527
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
0
0
- Multiple Cities
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Recruitment postcode(s) [1]
0
0
- Multiple Cities
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Arizona
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Country [2]
0
0
United States of America
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State/province [2]
0
0
California
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Colorado
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Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
District of Columbia
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Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Florida
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Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Hawaii
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Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Indiana
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Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Missouri
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Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Nebraska
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Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
New Jersey
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Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
North Carolina
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Country [12]
0
0
United States of America
Query!
State/province [12]
0
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Ohio
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United States of America
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Oregon
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Pennsylvania
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United States of America
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South Carolina
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Texas
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United States of America
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Vermont
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Argentina
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Brazil
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Chile
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Czech Republic
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Germany
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Guatemala
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Hungary
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India
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Mexico
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Netherlands
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New Zealand
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Peru
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Poland
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South Africa
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United Kingdom
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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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Ethics approval
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Summary
Brief summary
The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily
(QD), combined with metformin in adults with type 2 diabetes mellitus.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00286442
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Public notes
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Contacts
Principal investigator
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VP Biological Sciences
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Address
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Takeda
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00286442
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