At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 166 enrolled
Drug / intervention
Saxagliptin plus metformin IR +1 moredrug
Likely dose
Saxagliptin plus metformin IR 2.5 mgfrom 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, Parallel-Group, Phase 3 Trial to Evaluate the Efficacy and Safety of 2.5 mg Saxagliptin, Twice Daily, in Combination With Metformin IR in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin IR Alone
In Brief
A Phase 3 clinical trial evaluating Saxagliptin plus metformin IR and Placebo plus metformin IR for Type 2 Diabetes Mellitus. Completed, enrolled 166 participants across 41 sites in 4 countries.
Detailed Summary
The purpose of this study is to compare the reduction in hemoglobin A1C (A1C) for participants taking saxagliptin in combination with metformin immediate release (IR) versus metformin IR alone.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesGermany, Hungary, Puerto Rico, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 2009
Enrollment StartMay 2009
Primary CompletionFeb 2010
TodayJul 2026
First PostedApr 22, 2009
Enrollment StartMay 1, 2009
Primary CompletionFeb 1, 2010
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 17.2 years ago
Interventions
Saxagliptin plus metformin IRdrug
Tablets, Oral, 2.5 mg, Twice daily, 12 weeks
Placebo plus metformin IRdrug
Tablets, Oral, Placebo, Twice daily, 12 weeks