Conditions: Type 2 Diabetes High Blood Sugar
Keywords: Phase3 Clinical trial Type2 Diabetes Mellitus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 261
Healthy volunteers: no

Brief summary:
This is a 24-week randomised, multi-centre phase III study to evaluate the efficacy and safety of dapagliflozin as monotherapy in Japanese subjects with Type 2 diabetes mellitus who have inadequate glycemic control with diet and exercise.

Detailed description:

Arms:
arm 1: Dapagliflozin 5 mg arm 2: Dapagliflozin 10 mg arm 3: None

Interventions: intervention 1: Dapagliflozin intervention 2: Dapagliflozin intervention 3: Placebo
Intervention descriptions: intervention 1: Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose intervention 2: Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose intervention 3: Matching placebo for Dapagliflozin 5mg/10mg oral dose

Protocol document: