At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 374 enrolled
Drug / intervention
Alogliptin +2 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 Phase 3 Multicenter, Randomized, Double-blind, Parallel-group, Comparative Study When Metformin Hydrochloride 500 mg is Added on to SYR-322 25 mg in Type 2 Diabetic Patients
In Brief
A Phase 3 clinical trial evaluating Alogliptin, Metformin hydrochloride, and 1 other intervention for Type 2 Diabetes Mellitus. Completed, enrolled 374 participants across 27 sites.
Detailed Summary
The purpose of this study was to evaluate the efficacy and safety of 24-week treatment with metformin hydrochloride 500 mg once daily added on to alogliptin (SYR-322) 25 mg in type 2 diabetic patients with inadequate glycemic control despite treatment with alogliptin 25 mg in addition to diet and exercise therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2014
First PostedFeb 2014
Primary CompletionFeb 2015
TodayJul 2026
First PostedFeb 21, 2014
Enrollment StartFeb 1, 2014
Primary CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 12.4 years ago
Interventions
Alogliptindrug
Alogliptin tablets
Metformin hydrochloridedrug
Metformin hydrochloride tablets
Metformin hydrochloride Placebodrug
Metformin hydrochloride placebo-matching tablets