Conditions: Type 2 Diabetes
Keywords: Type 2 diabetes metformin treated inadequate control metformin treatment alone
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 400
Healthy volunteers: no

Brief summary:
This study is being carried out to see if dapagliflozin - administered in a daily dose of 2.5 mg given twice a day or 5 mg twice a day or 10mg once daily - in addition to metformin, is beneficial in diabetes treatment, and if so, how it compares to treatment with metformin alone.

Detailed description:

Arms:
arm 1: Dapagliflozin 2.5 mg twice-daily plus open-label metformin arm 2: Dapagliflozin 5.0 mg twice-daily plus open-label metformin arm 3: Dapagliflozin 10 mg once-daily plus open-label metformin arm 4: Placebo plus open-label metformin

Interventions: intervention 1: dapagliflozin intervention 2: dapagliflozin intervention 3: dapagliflozin intervention 4: metformin intervention 5: placebo
Intervention descriptions: intervention 1: 2.5 mg tablet, taken orally, twice daily intervention 2: 5 mg tablet taken orally, twice daily intervention 3: 10 mg tablet taken orally, once daily intervention 4: \>/= 1500 mg total daily dose, tablets taken orally, twice daily intervention 5: placebo

Protocol document: