At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 219 enrolled
Drug / intervention
Saxagliptin +4 moredrug
Likely dose
Saxagliptin 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 4-Week, Multicenter, Randomized, Double-Blind, Phase 3b Trial to Evaluate the Efficacy of Saxagliptin in Combination With Metformin XR 1500 mg Versus Up-titrated Metformin XR to 2000 mg in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise and a Stable Dose of Metformin XR 1500 mg
In Brief
A Phase 3 clinical trial evaluating Saxagliptin, Metformin XR, and 2 other interventions for Type 2 Diabetes. Completed, enrolled 219 participants across 21 sites in 4 countries.
Detailed Summary
The purpose of this study was to compare effect of Saxagliptin as add-on to Metformin on 24-hour mean weighted glucose (MWG) to the effect of uptitrating Metformin in subjects with T2DM inadequately controlled on metformin alone.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes
CountriesArgentina, Israel, Mexico, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 2009
Enrollment StartAug 2009
Primary CompletionMay 2010
TodayJul 2026
First PostedJun 11, 2009
Enrollment StartAug 1, 2009
Primary CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 17.1 years ago
Interventions
Saxagliptindrug
Tablets, Oral, 5 mg, once daily, 4 weeks
Metformin XRdrug
Tablets, Oral, 1500 mg, once daily, 4 weeks
Placebo matching Metformin XRdrug
Tablets, Oral, 0 mg, once daily, 4 weeks
Metformin XRdrug
Tablets, Oral, 500 mg, once daily, 4 weeks
Placebo matching Saxagliptindrug
Tablets, Oral, 0 mg, once daily, 4 weeks