Conditions: Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 660
Healthy volunteers: no

Brief summary:
The objective of the current study is to investigate the safety and efficacy of BI 10773 in 2 different doses compared to Metformin or to Sitagliptin given for 78 weeks in different modalities of treatment in patients with type 2 diabetes mellitus.

Detailed description:

Arms:
arm 1: 100 mg arm 2: 2000 mg arm 3: lower dose arm 4: higher dose

Interventions: intervention 1: BI 10773 intervention 2: Metformin intervention 3: BI 10773 intervention 4: Sitagliptin
Intervention descriptions: intervention 1: BI 10773 high dose once daily intervention 2: open label comparator intervention 3: BI 10773 low dose once daily intervention 4: open label comparator

Protocol document: