Empagliflozin as Adjunctive to Insulin Therapy Over 26 Weeks in Patients With T1DM (EASE-3)
Summary
The study will investigate the efficacy, safety, tolerability and Pharmacokinetic(PK) of 3 doses of empagliflozin compared with placebo over 26 weeks in 960 patients with type 1 diabetes mellitus as adjunctive therapy to insulin
Timeline
- Start
- 2015-12-22
- Primary completion
- 2017-09-12
- Completion
- 2017-09-20
Outcome
Met primary endpoint
registry analysis (superiority test); Placebo Matching Empagliflozin vs Empagliflozin 2.5 Milligram (mg); p <0.0001; Mean Difference (Final Values) -0.28 (99% CI -0.46 to -0.11) NCT02580591 ↗
registry analysis (superiority test); Placebo Matching Empagliflozin vs Empagliflozin 10 mg; p <0.0001; Mean Difference (Final Values) -0.45 (97.5% CI -0.60 to -0.30) NCT02580591 ↗
registry analysis (superiority test); Placebo Matching Empagliflozin vs Empagliflozin 25 mg; p <0.0001; Mean Difference (Final Values) -0.52 (97.5% CI -0.68 to -0.37) NCT02580591 ↗
registry analysis (superiority test); Placebo Matching Empagliflozin vs Empagliflozin 2.5 Milligram (mg); Mean Difference (Final Values) -0.27 (95% CI -0.40 to -0.14) NCT02580591 ↗
Publications
- Song C, Dhaliwal S, Bapat P, Scarr D, Bakhsh A, Budhram D, Verhoeff NJ, Weisman A, Fralick M, Ivers NM, Cherney DZI, Tomlinson G, Lovblom LE, Mumford D, Perkins BA. Point-of-Care Capillary Blood Ketone Measurements and the Prediction of Future Ketoacidosis Risk in Type 1 Diabetes. Diabetes Care. 2023 Nov 1;46(11):1973-1977. doi: 10.2337/dc23-0840.
- Rosenstock J, Marquard J, Laffel LM, Neubacher D, Kaspers S, Cherney DZ, Zinman B, Skyler JS, George J, Soleymanlou N, Perkins BA. Empagliflozin as Adjunctive to Insulin Therapy in Type 1 Diabetes: The EASE Trials. Diabetes Care. 2018 Dec;41(12):2560-2569. doi: 10.2337/dc18-1749. Epub 2018 Oct 4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Empagliflozin | Small molecule | 2.5 mg | Oral |
| Subject | Empagliflozin | Small molecule | 10 mg | Oral |
| Subject | Empagliflozin | Small molecule | 25 mg | Oral |