Conditions: Type 2 Diabetes Mellitus
Keywords: Dapagliflozin Metformin Type 2 diabetes body weight
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 182
Healthy volunteers: no

Brief summary:
This study is being carried out to see if dapagliflozin in addition to metformin decreases body weight and if so, how it compares with metformin alone.

Detailed description:

Arms:
arm 1: Dapagliflozin 10 mg plus Metformin arm 2: Placebo plus Metformin

Interventions: intervention 1: Dapagliflozin intervention 2: Metformin intervention 3: Sitagliptin intervention 4: Placebo
Intervention descriptions: intervention 1: Tablet oral 10 mg total daily dose once daily 102 weeks intervention 2: Tablet oral 1500 - 2500 mg total daily dose 1-3 times a day104 weeks intervention 3: Tablet oral 100 mg total daily dose once daily rescue medication intervention 4: Matching placebo for dapagliflozin, tablet, oral, once daily, 102 weeks

Protocol document: