Conditions: Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 708
Healthy volunteers: no

Brief summary:
The objective of the study is to investigate the efficacy, safety and tolerability of linagliptin 5 mg qd compared to placebo given for 24 weeks in inadequately controlled T2DM patients on empagliflozin 10 mg or 25 mg and maximum tolerated dose of metformin. The primary objective of efficacy evaluation is planned after 24 weeks of treatment. The study is designed to show superiority of the combination of empagliflozin and linagliptin over empagliflozin alone.

Detailed description:

Arms:
arm 1: Empagliflozin open label treatment period arm 2: Empagliflozin / Linagliptin 10/5 mg Dose FDC placebo add on run-in arm 3: Empagliflozin / Linagliptin 25/5 mg Dose FDC active arm 4: Empagliflozin / Linagliptin 10/5 mg Dose FDC placebo arm 5: Empagliflozin / Linagliptin 10/5 mg Dose FDC active arm 6: Empagliflozin open label treatment period arm 7: Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo arm 8: Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo add on run-in

Interventions: intervention 1: BI 10773 intervention 2: BI 10773 Placebo intervention 3: BI 10773 / BI 1356 intervention 4: BI 10773 intervention 5: BI 10773 / BI 1356 intervention 6: BI 10773 / BI 1356 Placebo intervention 7: BI 10773 intervention 8: BI 10773 intervention 9: BI 10773 intervention 10: BI 10773 / BI 1356 Placebo intervention 11: BI 10773 Placebo intervention 12: BI 10773 / BI 1356 Placebo intervention 13: BI 10773 intervention 14: BI 10773 / BI 1356 Placebo
Intervention descriptions: intervention 1: Empagliflozin active intervention 2: Empagliflozin placebo intervention 3: Empagliflozin / Linagliptin 25/5 mg Dose FDC active intervention 4: Empagliflozin active intervention 5: Empagliflozin / Linagliptin 10/5 mg Dose FDC active intervention 6: Empagliflozin / Linagliptin 10/5 mg Dose placebo FDC intervention 7: Empagliflozin active intervention 8: Empagliflozin active intervention 9: Empagliflozin active intervention 10: Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo intervention 11: Empagliflozin placebo intervention 12: Empagliflozin / Linagliptin 10/5 mg Dose FDC placebo intervention 13: Empagliflozin active intervention 14: Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo

Protocol document: