Clinical trial NCT01289990
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2011-02-01; Completion date: 2013-05-01
Enrollment: 2705 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will investigate the efficacy and long term safety and tolerability of BI 10773 in type 2 diabetic patients.

Detailed description:

Arms: arm 1: BI 10773 tablets once daily arm 2: BI 10773 tablets once daily arm 3: Placebo tablets matching BI 10773 / Sitagliptin once daily arm 4: Sitagliptin once daily arm 5: BI 10773 tablets once daily arm 6: BI 10773 tablets once daily arm 7: Placebo tablets matching BI 10773 once daily arm 8: BI 10773 tablets once daily arm 9: BI 10773 tablets once daily arm 10: Placebo tablets matching BI 10773 once daily arm 11: BI 10773 tablets once daily arm 12: BI 10773 tablets once daily arm 13: Placebo tablets matching BI 10773
Interventions: intervention 1: BI 10773 intervention 2: Placebo intervention 3: Placebo intervention 4: Placebo intervention 5: Placebo intervention 6: Placebo intervention 7: BI 10773 intervention 8: Placebo intervention 9: Placebo intervention 10: BI 10773 intervention 11: Placebo intervention 12: Placebo intervention 13: Placebo intervention 14: BI 10773 intervention 15: BI 10773 intervention 16: BI 10773 intervention 17: Placebo intervention 18: BI 10773 intervention 19: Placebo intervention 20: Placebo intervention 21: Placebo intervention 22: Sitagliptin 100mg intervention 23: BI 10773 intervention 24: Placebo intervention 25: Placebo intervention 26: Placebo intervention 27: Placebo intervention 28: Placebo intervention 29: Placebo intervention 30: Placebo
Intervention descriptions: intervention 1: BI 10773 tablets once daily intervention 2: Placebo matching BI 10773 low dose intervention 3: Placebo matching BI 10773 high dose intervention 4: Placebo matching Sitagliptin intervention 5: Placebo matching BI 10773 high dose intervention 6: Placebo matching BI 10773 high dose intervention 7: BI 10773 tablets once daily intervention 8: Placebo matching BI 10773 low dose intervention 9: Placebo matching BI 10773 low dose intervention 10: BI 10773 tablets once daily intervention 11: Placebo matching BI 10773 low dose intervention 12: Placebo matching BI 10773 high dose intervention 13: Placebo matching Sitagliptin intervention 14: BI 10773 tablets once daily intervention 15: BI 10773 tablets once daily intervention 16: BI 10773 tablets once daily intervention 17: Placebo matching BI 10773 high dose intervention 18: BI 10773 tablets once daily intervention 19: Placebo matching BI 10773 low dose intervention 20: Placebo matching BI 10773 high dose intervention 21: Placebo matching Sitagliptin intervention 22: Sitagliptin once daily intervention 23: BI 10773 tablets once daily intervention 24: Placebo matching BI 10773 low dose intervention 25: Placebo matching BI 10773 low dose intervention 26: Placebo matching BI 10773 low dose intervention 27: Placebo matching BI 10773 high dose intervention 28: Placebo matching BI 10773 low dose intervention 29: Placebo matching BI 10773 high dose intervention 30: Placebo matching BI 10773 high dose

Protocol documents: