Confirmatory Study of MT-2412 in Japanese Patients With Type 2 Diabetes (Add-on Study of Teneligliptin)

Summary

The purpose of this study is to evaluate the efficacy and safety of co-administration of Canagliflozin (TA-7284) and Teneligliptin (MP-513) once daily for 24 weeks in Japanese patients with Type 2 diabetes mellitus who are receiving treatment with Canagliflozin and have inadequate glycemic control.

Timeline

Start

2015-01

Primary completion

2016-02

Completion

2016-02

Outcome

Met primary endpoint

registry analysis (superiority test); Teneligliptin+Canagliflozin vs Placebo+Canagliflozin; p <0.001; Least Squares Mean Difference -0.94 (95% CI -1.16 to -0.72); ANCOVA NCT02354222 ↗

Publications

• Results Kadowaki T, Inagaki N, Kondo K, Nishimura K, Kaneko G, Maruyama N, Nakanishi N, Gouda M, Iijima H, Watanabe Y. Efficacy and safety of teneligliptin added to canagliflozin monotherapy in Japanese patients with type 2 diabetes mellitus: A multicentre, randomized, double-blind, placebo-controlled, parallel-group comparative study. Diabetes Obes Metab. 2018 Feb;20(2):453-457. doi: 10.1111/dom.13079. Epub 2017 Sep 15.

Drugs

Indications