Conditions: Type 2 Diabetes
Keywords: Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Metformin Hypoglycemic Agents Pharmacologic Actions Physiological Effects of Drugs
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 915
Healthy volunteers: no

Brief summary:
The purpose of this clinical research study is to learn whether dapagliflozin can help reduce blood sugar levels in participants with Type 2 diabetes that is not well controlled on metformin alone. The safety of this treatment will also be studied.

Detailed description:

Arms:
arm 1: Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks arm 2: Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks arm 3: Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks arm 4: Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks

Interventions: intervention 1: Dapagliflozin intervention 2: Placebo intervention 3: Metformin
Intervention descriptions: intervention 1: Tablets administered orally as a 2.5-, 5-, or 10-mg dose once daily for up to 102 weeks intervention 2: Dapagliflozin-matching placebo administered as tablets orally once daily for up to 102 weeks intervention 3: Open-label metformin administered as ≥1500 mg per day for up to 102 weeks

Protocol document: