Empagliflozin (BI 10773) Dose Finder Study in Japanese Patients With Type 2 Diabetes Mellitus

Summary

This study is conducted to determine the most appropriate therapeutic doses of BI 10773 in Japanese patients with T2DM at first treatment period. The second treatment period is required to obtain sufficient safety data (one-year exposure to BI 10773) in Japanese patients with T2DM according to the ICH E1 guideline.

Timeline

Start

2010-09

Primary completion

2012-06

Completion

2012-06

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo (12 Week) vs Empa 5mg (12 Week); p <0.0001; Mean Difference (Final Values) -0.72 (95% CI -0.87 to -0.57) NCT01193218 ↗

registry analysis (superiority or other test); Placebo (12 Week) vs Empa 50mg (12 Week); p <0.0001; Mean Difference (Final Values) -0.91 (95% CI -1.06 to -0.76) NCT01193218 ↗

Publications

• Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.
• 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.
• Shiba T, Ishii S, Okamura T, Mitsuyoshi R, Pfarr E, Koiwai K. Efficacy and safety of empagliflozin in Japanese patients with type 2 diabetes mellitus: A sub-analysis by body mass index and age of pooled data from three clinical trials. Diabetes Res Clin Pract. 2017 Sep;131:169-178. doi: 10.1016/j.diabres.2017.07.004. Epub 2017 Jul 8.
• Kadowaki T, Haneda M, Inagaki N, Terauchi Y, Taniguchi A, Koiwai K, Rattunde H, Woerle HJ, Broedl UC. Efficacy and safety of empagliflozin monotherapy for 52 weeks in Japanese patients with type 2 diabetes: a randomized, double-blind, parallel-group study. Adv Ther. 2015 Apr;32(4):306-18. doi: 10.1007/s12325-015-0198-0. Epub 2015 Apr 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Empagliflozin	Small molecule	5 mg	Oral
Subject	Empagliflozin	Small molecule	10 mg	Oral
Subject	Empagliflozin	Small molecule	25 mg	Oral
Subject	Empagliflozin	Small molecule	50 mg	Oral

Indications