A Multi-center 12-week Study of HMS5552 in T2DM

Summary

This study evaluates the safety, tolerability, efficacy and population PK of HMS5552 in type 2 diabetic adult subjects,there will be 5 groups ,4 groups will receive HMS5552,while 1 will receive placebo.

Timeline

Start

2015-09

Primary completion

2016-09

Completion

2016-09

Outcome

Met primary endpoint

paper change in HbA1c between baseline and 12 weeks was significant in the 50 mg twice daily (p=0·0104) and the 75 mg twice daily (p<0·0001) PMID 29735394 ↗

paper Compared with the placebo group, the change in HbA1c between baseline and 12 weeks was significant PMID 29735394 ↗

Publications

• Zhu D, Gan S, Liu Y, Ma J, Dong X, Song W, Zeng J, Wang G, Zhao W, Zhang Q, Li Y, Fang H, Lv X, Shi Y, Tian H, Ji L, Gao X, Zhang L, Bao Y, Lei M, Li L, Zeng L, Li X, Hou X, Zhao Y, Hu T, Ge X, Zhao G, Li Y, Zhang Y, Chen L. Dorzagliatin monotherapy in Chinese patients with type 2 diabetes: a dose-ranging, randomised, double-blind, placebo-controlled, phase 2 study. Lancet Diabetes Endocrinol. 2018 Aug;6(8):627-636. doi: 10.1016/S2213-8587(18)30105-0. Epub 2018 May 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dorzagliatin	Small molecule	50 mg	Oral
Subject	Dorzagliatin	Small molecule	75 mg	Oral
Subject	Dorzagliatin	Small molecule	100 mg	Oral

Indications