Conditions: Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1405
Healthy volunteers: no

Brief summary:
This trial will evaluate use of BI 10773/linagliptin once daily (qd) fixed dose combination (FDC) in treatment naïve and metformin treated patients with type 2 diabetes mellitus to support approval by regulatory authorities.

Detailed description:

Arms:
arm 1: Patients receive BI 10773/linagliptin FDC (high dose) once daily arm 2: Patients receive BI 10773/linagliptin FDC (low dose) once daily arm 3: Patients receive BI 10773 (high dose) once daily arm 4: Patients receive BI 10773 (low dose) once daily arm 5: Patients receive linagliptin once daily

Interventions: intervention 1: high dose FDC intervention 2: BI 10773 high dose intervention 3: high dose FDC placebo intervention 4: low dose FDC placebo intervention 5: high dose FDC placebo intervention 6: high dose FDC placebo intervention 7: low dose FDC placebo intervention 8: low dose FDC placebo intervention 9: high dose BI 10773 placebo intervention 10: low dose FDC intervention 11: high dose FDC placebo intervention 12: BI 10773 low dose intervention 13: high dose BI 10773 placebo intervention 14: high dose BI 10773 placebo intervention 15: linagliptin intervention 16: low dose FDC placebo intervention 17: linagliptin placebo intervention 18: BI 10773 low dose placebo intervention 19: linagliptin placebo intervention 20: low dose BI 10773 placebo intervention 21: linagliptin placebo intervention 22: high dose BI 10773 placebo intervention 23: BI 10773 low dose placebo intervention 24: low dose BI 10773 placebo intervention 25: linagliptin placebo
Intervention descriptions: intervention 1: once daily intervention 2: once daily intervention 3: once daily intervention 4: once daily intervention 5: once daily intervention 6: once daily intervention 7: once daily intervention 8: once daily intervention 9: once daily intervention 10: once daily intervention 11: once daily intervention 12: low dose once daily intervention 13: once daily intervention 14: once daily intervention 15: once daily intervention 16: once daily intervention 17: once daily intervention 18: once daily intervention 19: once daily intervention 20: once daily intervention 21: once daily intervention 22: once daily intervention 23: once daily intervention 24: once daily intervention 25: once daily

Protocol document: