At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 784 enrolled
Drug / intervention
Alogliptin +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of Alogliptin Plus Metformin, Alogliptin Alone, or Metformin Alone in Subjects With Type 2 Diabetes
In Brief
A Phase 3 clinical trial evaluating Alogliptin, Metformin, and 2 other interventions for Diabetes Mellitus, Type 2. Completed, enrolled 784 participants across 201 sites in 13 countries.
Detailed Summary
The purpose of this study is to evaluate the safety and effectiveness of alogliptin combined with metformin, once daily (QD) or twice daily (BID), in participants with Type 2 Diabetes.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesCzechia, Hungary, Israel, Lithuania, Mexico, Poland, Puerto Rico, Romania, Russia, Slovakia, South Africa, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2009
First PostedDec 2009
Primary CompletionJun 2011
TodayJul 2026
First PostedDec 2, 2009
Enrollment StartNov 1, 2009
Primary CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 16.6 years ago
Interventions
Alogliptindrug
Alogliptin tablets.
Metformindrug
Metformin capsules
Alogliptin Placebodrug
Alogliptin placebo-matching tablets.
Metformin Placebodrug
Metformin placebo-matching capsules.