A Study to Test How Well Empagliflozin Works in Japanese People With Type 2 Diabetes Who Are Older Than 65 Years

Summary

This study is to assess the efficacy of empagliflozin 10 mg after 52 weeks compared to placebo in elderly patients with Type 2 diabetes mellitus (T2DM) and to explore if empagliflozin has any impact on patient physical condition compared to placebo in elderly patients with T2DM.

Timeline

Start

2020-10-05

Primary completion

2022-08-19

Completion

2022-08-26

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs Empagliflozin 10 mg; p <0.0001; Mean Difference (Net) -0.57 (95% CI -0.78 to -0.36) NCT04531462 ↗

Publications

• Yabe D, Shiki K, Suzaki K, Meinicke T, Kotobuki Y, Nishida K, Clark D, Yasui A, Seino Y. Rationale and design of the EMPA-ELDERLY trial: a randomised, double-blind, placebo-controlled, 52-week clinical trial of the efficacy and safety of the sodium-glucose cotransporter-2 inhibitor empagliflozin in elderly Japanese patients with type 2 diabetes. BMJ Open. 2021 Apr 7;11(4):e045844. doi: 10.1136/bmjopen-2020-045844.

Drugs

Indications