Empa Add on to Insulin in Japanese Patient With Type 1 Diabetes Mellitus

NCT02702011 ↗

Phase 2 Completed 48 enrolled Boehringer Ingelheim Eli Lilly and Company · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

To assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of once daily oral doses of empagliflozin in Japanese patients with type 1 diabetes mellitus as adjunctive therapy to insulin.

Timeline

Start: 2016-03-20
Primary completion: 2016-09-05
Completion: 2016-10-03

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo vs Empagliflozin 2.5 mg; p <0.0001; Mean Difference (Net) 65.10 (95% CI 43.29 to 86.90); ANCOVA NCT02702011 ↗

paper Empagliflozin resulted in a dose-dependent significant increase in 24-hour UGE compared with placebo PMID 29766633 ↗

Publications

Shimada A, Hanafusa T, Yasui A, Lee G, Taneda Y, Sarashina A, Shiki K, George J, Soleymanlou N, Marquard J. Empagliflozin as adjunct to insulin in Japanese participants with type 1 diabetes: Results of a 4-week, double-blind, randomized, placebo-controlled phase 2 trial. Diabetes Obes Metab. 2018 Sep;20(9):2190-2199. doi: 10.1111/dom.13351. Epub 2018 Jun 5.

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