Conditions: Type 2 Diabetes Mellitus High HbA1c Level Inadequate Glycaemic Control
Keywords: dapagliflozin diabetes hyperglycaemia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 311
Healthy volunteers: no

Brief summary:
This study intends to compare the efficacy and safety of dapagliflozin versus placebo in patients with type 2 diabetes who have inadequate glycaemic control on a background combination of metformin and sulfonylurea.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: dapagliflozin intervention 2: placebo
Intervention descriptions: intervention 1: 10 mg tablet, oral, once daily, 24- week treatment and 28- week extension period intervention 2: matching placebo tablet, oral, once daily, 24- week treatment and 28- week extension period

Protocol document: