At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 647 enrolled
Drug / intervention
Alogliptin +5 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 and Metformin Fixed Dose Combination, Alogliptin Alone, or Metformin Alone in Subjects With Type 2 Diabetes Mellitus
In Brief
A Phase 3 clinical trial evaluating Alogliptin, Metformin HCl, and 4 other interventions for Diabetes Mellitus. Completed, enrolled 647 participants across 45 sites in 4 countries.
Detailed Summary
The purpose of this study is to evaluate the efficacy and safety of alogliptin and metformin fixed-dose combination (FDC) as compared with alogliptin alone or metformin alone on Type 2 Diabetes Mellitus (T2DM).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus
CountriesChina, Malaysia, South Korea, Taiwan
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 2013
Enrollment StartSep 2013
Primary CompletionSep 2015
Study CompletionOct 2015
TodayJul 2026
First PostedJul 1, 2013
Enrollment StartSep 1, 2013
Primary CompletionSep 1, 2015
Study CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 13.0 years ago
Interventions
Alogliptindrug
Alogliptin tablets
Metformin HCldrug
Metformin HCl capsules
Alogliptin and Metformin Fixed-Dose Combination (FDC)drug
Alogliptin and metformin FDC tablets
Alogliptin Placebodrug
Alogliptin placebo-matching tablets
Metformin Placebodrug
Metformin placebo-matching capsules
Alogliptin and Metformin FDC Placebodrug
Alogliptin and metformin FDC placebo-matching tablets