Conditions: Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1549
Healthy volunteers: no

Brief summary:
This is a pivotal phase III study, mandatory to seek approval by regulatory authorities for BI 10773 as an anti-diabetic agent compared to an active comparator in patients with type 2 diabetes mellitus and insufficient glycaemic control.

Detailed description:

Arms:
arm 1: Patients receive one BI10773 tablet and one placebo Glimepiride capsule once daily arm 2: Patients receive one glimepiride capsule and one placebo tablet Bi 10773 once daily.

Interventions: intervention 1: BI 10773 intervention 2: Glimepiride intervention 3: Placebo intervention 4: Placebo
Intervention descriptions: intervention 1: Medium dose once daily intervention 2: 1-4 mg once daily intervention 3: Placebo matching BI 10773 intervention 4: Placebo matching Glimepiride

Protocol document: