Conditions: Diabetes Mellitus, Type 2 Obesity
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 566
Healthy volunteers: no

Brief summary:
This trial will evaluate use of BI 10773 as add-on to insulin regimen alone or with metformin in patients with typr 2 diabetes. Both lowering glucose and HbA1c and reducing the use of insulin in this population would provide significant new information for the BI 10773 use and would offer a potential new therapeutic option in this population.

Detailed description:

Arms:
arm 1: BI 10773 low dose once daily arm 2: BI 10733 high dose once daily arm 3: Placebo tablets matching BI 10773

Interventions: intervention 1: Placebo intervention 2: Placebo intervention 3: Placebo intervention 4: Placebo intervention 5: BI 10773 intervention 6: BI 10773
Intervention descriptions: intervention 1: Placebo matching BI 10773 low dose intervention 2: Placebo matching BI 10773 low dose intervention 3: Placebo matching BI 10773 high dose intervention 4: Placebo matching BI 10773 high dose intervention 5: BI 10773 low dose once daily intervention 6: BI 10773 high dose once daily

Protocol document: