Conditions: Diabetes
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 477
Healthy volunteers: no

Brief summary:
The purpose is to determine if after 24 weeks of oral daily administration, there will be a greater mean reduction from baseline in glycosylated hemoglobin (HbA1c) achieved with Dapagliflozin 10 mg plus insulin compared to placebo plus insulin in subjects with type 2 diabetes.

Detailed description:

Arms:
arm 1: Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin arm 2: Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin

Interventions: intervention 1: Dapagliflozin intervention 2: Dapagliflozin Placebo
Intervention descriptions: intervention 1: Tablet intervention 2: Tablet

Protocol document: