drugset / Trial / NCT01422876
Efficacy and Safety of Empagliflozin (BI 10773) / Linagliptin (BI 1356) Fixed Dose Combination in Treatment naïve and Metformin Treated Type 2 Diabetes Patients
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2011-08
- Primary completion
- 2013-09
- Completion
- 2013-09
Publications
- DeFronzo RA, Lee C, Kohler S. Safety and Tolerability of Combinations of Empagliflozin and Linagliptin in Patients with Type 2 Diabetes: Pooled Data from Two Randomized Controlled Trials. Adv Ther. 2018 Jul;35(7):1009-1022. doi: 10.1007/s12325-018-0724-y. Epub 2018 Jun 15.
- Lewin A, DeFronzo RA, Patel S, Liu D, Kaste R, Woerle HJ, Broedl UC. Initial combination of empagliflozin and linagliptin in subjects with type 2 diabetes. Diabetes Care. 2015 Mar;38(3):394-402. doi: 10.2337/dc14-2365. Epub 2015 Jan 29.
- DeFronzo RA, Lewin A, Patel S, Liu D, Kaste R, Woerle HJ, Broedl UC. Combination of empagliflozin and linagliptin as second-line therapy in subjects with type 2 diabetes inadequately controlled on metformin. Diabetes Care. 2015 Mar;38(3):384-93. doi: 10.2337/dc14-2364. Epub 2015 Jan 12.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Empagliflozin | Small molecule | 10 mg | Oral |
| Comparator | Empagliflozin | Small molecule | 25 mg | Oral |
| Comparator | Linagliptin | Small molecule | 5 mg | Oral |