At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 282 enrolled
Drug / intervention
Saxagliptin +2 moredrug
Likely dose
Saxagliptin 5mgfrom 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.
18-Week, Multicenter, Randomized, Double-Blind 3b Trial to Evaluate Efficacy/Safety of Saxagliptin in Combo With Metformin XR 1500mg vs Metformin Uptitrated to 2000mg in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control After Diet/Exercise and a Stable Dose of Metformin XR 1500mg
In Brief
A Phase 3 clinical trial evaluating Saxagliptin and Metformin XR for Type 2 Diabetes. Completed, enrolled 282 participants across 35 sites in 5 countries.
Detailed Summary
The purpose of this study is to compare reduction in A1C for subjects taking Saxagliptin and Metformin XR vs. uptitrated Metformin XR.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes
CountriesColombia, Costa Rica, Mexico, Peru, United States
CollaboratorsBristol-Myers Squibb
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartAug 2009
First PostedAug 2009
Primary CompletionOct 2010
TodayJul 2026
First PostedAug 17, 2009
Enrollment StartAug 1, 2009
Primary CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 16.9 years ago
Interventions
Saxagliptindrug
5mg oral tablet once daily
Metformin XRdrug
500mg oral tablet once daily
Metformin XRdrug
750mg, 2 tablets once daily