At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Add-On Therapy With Saxagliptin and Dapagliflozin Added to Metformin Compared to Add-On Therapy With Saxagliptin in Combination With Metformin or Dapagliflozin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone.
In Brief
A Phase 3 clinical trial evaluating Saxagliptin, Metformin XR, and 3 other interventions for Type 2 Diabetes. Completed, enrolled 1,282 participants across 139 sites in 8 countries.
Detailed Summary
The purpose of this study is to learn if a combination of BMS-477118 (Saxagliptin) and BMS -512148 (Dapagliflozin) added to Metformin can improve (decrease) Glycosylated Hemoglobin (Hemoglobin A1c) in patients with type 2 diabetes after 24 weeks of treatment. The safety of this treatment will also be studied.
Study Details
Timeline
Interventions
Tablets, Oral, 5mg , Once daily, 24 weeks
Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks
Tablets, Oral, 10mg , Once daily, 24 weeks
Tablets, Oral, 0mg, Once daily, 24 weeks
Tablets, Oral, 0mg, Once daily, 24 weeks