Conditions: Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 494
Healthy volunteers: no

Brief summary:
The objective of the current study is to investigate the efficacy, safety and tolerability of BI 10773 at two different doses compared to placebo during long term treatment (78 weeks) in combination with basal insulin in patients with type 2 diabetes mellitus with insufficient glycaemic control.

Detailed description:

Arms:
arm 1: Patients receive BI 10773 low dose daily arm 2: Patients receive BI 10773 high dose daily arm 3: Patients receive placebo to match BI 10773 daily

Interventions: intervention 1: BI 10773 placebo intervention 2: BI 10773 low dose intervention 3: BI 10773 high dose intervention 4: BI 10773 placebo
Intervention descriptions: intervention 1: BI 10773 placebo intervention 2: BI 10773 low dose intervention 3: BI 10773 high dose intervention 4: BI 10773 placebo

Protocol document: