Efficacy and Safety of Empagliflozin (BI 10773) in Patients With Type 2 Diabetes and Renal Impairment
Summary
This study will investigate the efficacy and safety of the BI 10773 in type 2 diabetic patients with renal impairment in order to provide these data for approval for BI 10773 as an antidiabetic agent by regulatory authorities.
Timeline
- Start
- 2010-07
- Primary completion
- 2012-07
- Completion
- 2012-07
Outcome
Met primary endpoint
registry Placebo vs Empa 25mg; p <0.0001; Mean Difference (Final Values) -0.51 (95% CI -0.62 to -0.39); ANCOVA NCT01164501 ↗
registry Placebo vs Empa 10mg; p <0.0001; Mean Difference (Final Values) -0.52 (95% CI -0.72 to -0.32); ANCOVA NCT01164501 ↗
registry Placebo vs Empa 25mg; p <0.0001; Mean Difference (Final Values) -0.68 (95% CI -0.88 to -0.49); ANCOVA NCT01164501 ↗
registry Placebo vs Empa 25mg; p <0.0001; Mean Difference (Final Values) -0.42 (95% CI -0.56 to -0.28); ANCOVA NCT01164501 ↗
release “for empagliflozin 25 mg, reduction in HbA1c was 0.42 percent (p < 0.001) in patients with moderate renal impairment versus placebo” lilly.com ↗
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.
- Barnett AH, Mithal A, Manassie J, Jones R, Rattunde H, Woerle HJ, Broedl UC; EMPA-REG RENAL trial investigators. Efficacy and safety of empagliflozin added to existing antidiabetes treatment in patients with type 2 diabetes and chronic kidney disease: a randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2014 May;2(5):369-84. doi: 10.1016/S2213-8587(13)70208-0. Epub 2014 Jan 24.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Empagliflozin | Small molecule | 10 mg | Oral |
| Subject | Empagliflozin | Small molecule | 25 mg | Oral |