Conditions: Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1162
Healthy volunteers: no

Brief summary:
The objective of the study is to investigate the long-term safety and efficacy of BI 10773 given for 52 weeks as add-on therapy to one oral antidiabetic drug in patients with type 2 diabetes mellitus with insufficient glycaemic control.

Detailed description:

Arms:
arm 1: BI 10773 low dose tablet once daily arm 2: BI 10773 high dose tablet once daily arm 3: Metformin tablets 500-2250 mg a day (twice or three times per day)

Interventions: intervention 1: Metformin intervention 2: BI 10773 intervention 3: Placebo (low dose) intervention 4: BI 10773 intervention 5: Placebo (high dose)
Intervention descriptions: intervention 1: Metformin tablets 500-2250 mg a day (twice or three times per day) intervention 2: BI 10773 low dose tablet once daily intervention 3: Placebo tablets once daily intervention 4: BI 10773 high dose tablet once daily intervention 5: Placebo tablets once daily

Protocol document: