Empagliflozin as Adjunctive to InSulin thErapy Over 52 Weeks in Patients With Type 1 Diabetes Mellitus (EASE-2)
Summary
Comparison of 2 doses of empagliflozin vs placebo in patients already using either an insulin regimen of multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII). Randomisation to 3 treatments arms (equal assignment) following a screening period, an optimisation period and a run-in period. 52 week double-blind treatment period, and 3 week follow-up period.
Timeline
- Start
- 2015-06-30
- Primary completion
- 2017-04-20
- Completion
- 2017-10-23
Outcome
Met primary endpoint
registry Placebo Matching Empagliflozin vs Empagliflozin 10 mg; p <0.0001; Mean Difference (Final Values) -0.54 (97.5% CI -0.66 to -0.41) NCT02414958 ↗
registry Placebo Matching Empagliflozin vs Empagliflozin 25 mg; p <0.0001; Mean Difference (Final Values) -0.53 (97.5% CI -0.66 to -0.41) NCT02414958 ↗
registry Placebo Matching Empagliflozin vs Empagliflozin 10 mg; p <0.0001; Mean Difference (Final Values) -0.53 (97.5% CI -0.65 to -0.40) NCT02414958 ↗
registry Placebo Matching Empagliflozin vs Empagliflozin 25 mg; p <0.0001; Mean Difference (Final Values) -0.51 (97.5% CI -0.64 to -0.39) NCT02414958 ↗
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 | 10 mg | Oral |
| Subject | Empagliflozin | Small molecule | 25 mg | Oral |