Efficacy and Safety Study of Empagliflozin as add-on to Insulin in Japanese Patients With Type 2 Diabetes Mellitus

Phase 4 Completed 269 enrolled Boehringer Ingelheim Eli Lilly and Company · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

This is a multi-center, randomised, double-blind, placebo-controlled, parallel-group, efficacy and safety study of empagliflozin as add-on to insulin in Japanese patients with Type 2 Diabetes Mellitus with insufficient glycaemic control

Timeline

Start: 2015-10-28
Primary completion: 2017-04-18
Completion: 2018-01-05

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs Empagliflozin 10 mg; p <0.0001; Mean Difference (Final Values) -0.92 (95% CI -1.11 to -0.73); ANCOVA NCT02589639 ↗

registry analysis (superiority test); Placebo vs Empagliflozin 25 mg; p <0.0001; Mean Difference (Final Values) -1.00 (95% CI -1.18 to -0.82); ANCOVA NCT02589639 ↗

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Empagliflozin	Small molecule	10 mg	—
Subject	Empagliflozin	Small molecule	25 mg	—