SAL067 Treatment in Patients With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

Summary

This is the first phase 3 randomized, double-blind, placebo/active-controlled clinical study to evaluate the efficacy and long-term safety of SAL067 in treatment-naive T2DM patients uncontrolled with diet and exercise intervention, comprising 24 weeks of double-blind treatment period followed by an open-label treatment period, making up a total of 52 weeks.

Timeline

Start

2019-06-13

Primary completion

2022-03-25

Completion

2022-03-25

Publications

• Xu M, Sun K, Xu W, Wang C, Yan D, Li S, Cong L, Pi Y, Song W, Sun Q, Xiao R, Peng W, Wang J, Peng H, Zhang Y, Duan P, Zhang M, Liu J, Huang Q, Li X, Bao Y, Zeng T, Wang K, Qin L, Wu C, Deng C, Huang C, Yan S, Zhang W, Li M, Sun L, Wang Y, Li H, Wang G, Pang S, Zheng X, Wang H, Wang F, Su X, Ma Y, Zhang W, Li Z, Xie Z, Xu N, Ni L, Zhang L, Deng X, Pan T, Dong Q, Wu X, Shen X, Zhang X, Zou Q, Jiang C, Xi J, Ma J, Sun J, Yan L. Fotagliptin monotherapy with alogliptin as an active comparator in patients with uncontrolled type 2 diabetes mellitus: a randomized, multicenter, double-blind, placebo-controlled, phase 3 trial. BMC Med. 2023 Oct 9;21(1):388. doi: 10.1186/s12916-023-03089-x.

Drugs

Indications