Conditions: Type 2 Diabetes
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 320
Healthy volunteers: no

Brief 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.

Detailed description:
Prior to randomization, all eligible subjects will receive open-label treatment with Saxagliptin 5mg and Metformin IR during the 16-week open-label treatment period.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Dapagliflozin intervention 2: Placebo matching with Dapagliflozin intervention 3: Saxagliptin intervention 4: Metformin immediate release (IR)
Intervention descriptions: intervention 1: Tablets, Oral, 10 mg, Once daily, Up to 52 weeks intervention 2: Tablets, Oral, 0 mg, Once daily, Up to 52 weeks intervention 3: Tablets, Oral, 5 mg, Once daily, Up to 52 weeks intervention 4: Tablets, Oral, ≥ 1500 mg, Twice daily, Up to 52 weeks

Protocol document: