Conditions: Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 986
Healthy volunteers: no

Brief summary:
The aim of this study is to investigate the efficacy, safety and tolerability of BI 10773 compared to placebo and sitagliptin given for 24 weeks as monotherapy in patients with T2DM with insufficient glycaemic control. For the open-label part of the study the objective is to estimate the efficacy and safety of BI 10773 when given for 24 weeks in patients with T2DM with very poor glycaemic control.

Detailed description:

Arms:
arm 1: Patients receive BI 10773 low dose tablets once daily arm 2: Patients receive BI 10773 high dose tablets once daily arm 3: Patients receive tablets identical to those containing BI 10773 low dose and high dose and to Sitagliptin arm 4: Patients receive Sitagliptin 100 mg tablets once daily arm 5: Patients receive BI 10773 high dose tablets open label once daily

Interventions: intervention 1: Placebo identical to BI10773 high dose intervention 2: BI 10773 intervention 3: BI 10773 open label intervention 4: Placebo identical to BI10773 low dose intervention 5: Placebo identical to BI10773 low dose intervention 6: Placebo identical to BI10773 high dose intervention 7: Placebo identical to Sitagliptin 100mg intervention 8: Placebo identical to Sitagliptin 100mg intervention 9: BI10773 intervention 10: Sitagliptin intervention 11: Placebo identical to Sitagliptin 100mg intervention 12: Placebo identical to BI10773 low dose intervention 13: Placebo identical to BI10773 high dose
Intervention descriptions: intervention 1: placebo tablets once daily intervention 2: BI 10773 low dose tablet once daily intervention 3: Patients receive BI 10773 high dose tablets open label once daily intervention 4: placebo tablets once daily intervention 5: placebo tablets once daily intervention 6: placebo tablets once daily intervention 7: placebo tablets once daily intervention 8: placebo tablets once daily intervention 9: BI 10773 high dose tablets once daily intervention 10: Sitagliptin tablets 100 mg once daily intervention 11: placebo tablets once daily intervention 12: placebo tablets once daily intervention 13: placebo tablets once daily

Protocol document: