Efficacy and Safety of Empagliflozin (BI 10773) in Type 2 Diabetes Patients on a Background of Pioglitazone Alone or With Metformin
Summary
This study will investigate the efficacy and safety of BI 10773 in type 2 diabetic patients in order to provide these data for approval for BI 10773 by regulatory authorities as an antidiabetic agent as add-on therapy to pioglitazone alone or in combination with metformin.
Timeline
- Start
- 2010-09
- Primary completion
- 2012-04
- Completion
- —
Outcome
Met primary endpoint
registry Placebo vs Empa 10mg; p <0.0001; Mean Difference (Final Values) -0.48 (97.5% CI -0.69 to -0.27); ANCOVA; NCT01210001 ↗
registry Placebo vs Empa 25mg; p <0.0001; Mean Difference (Final Values) -0.61 (97.5% CI -0.82 to -0.40); ANCOVA; NCT01210001 ↗
registry Placebo vs Empa 10mg; p <0.0001; Mean Difference (Final Values) -0.45 (97.5% CI -0.69 to -0.21); ANCOVA; NCT01210001 ↗
registry Placebo vs Empa 25mg; p <0.0001; Mean Difference (Final Values) -0.60 (97.5% CI -0.83 to -0.36); ANCOVA; NCT01210001 ↗
Publications
- Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.
- Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsasser A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034.
- Cherney D, Lund SS, Perkins BA, Groop PH, Cooper ME, Kaspers S, Pfarr E, Woerle HJ, von Eynatten M. The effect of sodium glucose cotransporter 2 inhibition with empagliflozin on microalbuminuria and macroalbuminuria in patients with type 2 diabetes. Diabetologia. 2016 Sep;59(9):1860-70. doi: 10.1007/s00125-016-4008-2. Epub 2016 Jun 17.
- Kovacs CS, Seshiah V, Merker L, Christiansen AV, Roux F, Salsali A, Kim G, Stella P, Woerle HJ, Broedl UC; EMPA-REG EXTEND PIO investigators. Empagliflozin as Add-on Therapy to Pioglitazone With or Without Metformin in Patients With Type 2 Diabetes Mellitus. Clin Ther. 2015 Aug;37(8):1773-88.e1. doi: 10.1016/j.clinthera.2015.05.511. Epub 2015 Jun 29.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Empagliflozin | Small molecule | 10 mg | Oral |
| Subject | Empagliflozin | Small molecule | 25 mg | Oral |