Conditions: Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1504
Healthy volunteers: no

Brief summary:
The objective of the current study is to investigate the efficacy, safety and tolerability of two doses of BI 10773 compared to placebo given for 24 weeks as add-on therapy to metformin or metformin plus sulfonylurea in patients with Typ 2 Diabetes Mellitus with insufficient glycaemic control.

Detailed description:

Arms:
arm 1: BI 10773 once daily high dose arm 2: Placebo matching BI 10773 arm 3: BI 10773 once daily high dose open label arm 4: BI 10773 once daily low dose

Interventions: intervention 1: Placebo identical to BI 10773 high dose intervention 2: Placebo identical to BI 10773 low dose intervention 3: BI 10773 intervention 4: BI 10773 intervention 5: Placebo identical to BI 10773 low dose intervention 6: BI 10773 intervention 7: Placebo identical to BI 10773 high dose
Intervention descriptions: intervention 1: Placebo tablets matching BI 10773 high dose intervention 2: Placebo tablets matching BI 10773 low dose intervention 3: BI 10773 tablets once daily high dose open label intervention 4: BI 10773 tablets once daily high dose intervention 5: Placebo tablets matching BI 10773 low dose intervention 6: BI 10773 tablets once daily low dose intervention 7: Placebo tablets matching BI 10773 high dose

Protocol document: