At a glance
ClinicalIndex Comparison RecordStandardized 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 Safety and Efficacy of Therapy With Dapagliflozin Added to Saxagliptin in Combination With Metformin Compared to Therapy With Placebo Added to Saxagliptin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin and Saxagliptin
In Brief
A Phase 3 clinical trial evaluating Dapagliflozin, Placebo matching with Dapagliflozin, and 2 other interventions for Type 2 Diabetes. Completed, enrolled 320 participants across 66 sites in 8 countries.
Detailed Summary
The purpose of this study is to learn if BMS-512148 (Dapagliflozin) as part of a triple combination therapy can improve (decrease) hemoglobin A1c in patients with type 2 diabetes after 24 weeks of treatment compared to a 2 drug oral antidiabetic therapy. The safety of this treatment will also be studied.
Study Details
Timeline
Interventions
Tablets, Oral, 10 mg, Once daily, Up to 52 weeks
Tablets, Oral, 0 mg, Once daily, Up to 52 weeks
Tablets, Oral, 5 mg, Once daily, Up to 52 weeks
Tablets, Oral, ≥ 1500 mg, Twice daily, Up to 52 weeks