Conditions: Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 547
Healthy volunteers: no

Brief summary:
This study is conducted to determine the most appropriate therapeutic doses of BI 10773 in Japanese patients with T2DM at first treatment period. The second treatment period is required to obtain sufficient safety data (one-year exposure to BI 10773) in Japanese patients with T2DM according to the ICH E1 guideline.

Detailed description:

Arms:
arm 1: BI 10773 tablets low dose once a day arm 2: BI 10773 tablets mid-low dose once a day arm 3: BI 10773 tablets mid-high dose once a day arm 4: BI 10773 tablets high dose once a day arm 5: Placebo tablets once a day

Interventions: intervention 1: Placebo (low dose) intervention 2: Placebo (low dose) intervention 3: Placebo (mid dose) intervention 4: Placebo (high dose) intervention 5: BI 10773 intervention 6: Placebo (mid dose) intervention 7: Placebo (high dose) intervention 8: Placebo (high dose) intervention 9: BI 10773 intervention 10: BI 10773 intervention 11: Placebo (mid dose) intervention 12: Placebo (high dose) intervention 13: Placebo (low dose) intervention 14: Placebo (low dose) intervention 15: BI 10773 intervention 16: Placebo (mid dose)
Intervention descriptions: intervention 1: Placebo tablets once a day intervention 2: Placebo tablets once a day intervention 3: Placebo tablets once a day intervention 4: Placebo tablets once a day intervention 5: BI 10773 tablets low dose once a day intervention 6: Placebo tablets once a day intervention 7: Placebo tablets once a day intervention 8: Placebo tablets once a day intervention 9: BI 10773 tablets mid-high dose once a day intervention 10: BI 10773 tablets high dose once a day intervention 11: Placebo tablets once a day intervention 12: Placebo tablets once a day intervention 13: Placebo tablets once a day intervention 14: Placebo tablets once a day intervention 15: BI 10773 tablets mid-low dose once a day intervention 16: Placebo tablets once a day

Protocol document: