Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Metformin Dapagliflozin Hypoglycemic Agents Pharmacologic Actions Physiological Effects of Drugs
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1093
Healthy volunteers: no

Brief summary:
The primary purpose of this study is to compare the change from baseline in hemoglobin A1C achieved with dapagliflozin 10 mg in combination with metformin XR as compared with metformin XR monotherapy and compared with Dapagliflozin monotherapy, after 24 weeks of oral administration of double-blind treatment. The safety of treatment with dapagliflozin will also be assessed in this study

Detailed description:

Arms:
arm 1: Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks

Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks arm 2: Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks.

Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks. arm 3: Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks

Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks

Interventions: intervention 1: Dapagliflozin intervention 2: Metformin XR intervention 3: Metformin XR intervention 4: dapagliflozin matching Placebo intervention 5: metformin HCl Modified Release matching Placebo
Intervention descriptions: intervention 1: Tablets, Oral, 10 mg, once daily, 24 weeks intervention 2: Tablets, Oral, up to 2000 mg, once daily, 24 weeks intervention 3: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks intervention 4: Tablets intervention 5: Tablets

Protocol document: