Dorzagliatin monotherapy in Chinese patients with type 2 diabetes: a dose-ranging, randomised, double-blind, placebo-controlled, phase 2 study

This study is registered with ClinicalTrials.gov, number NCT02561338.FindingsBetween Sept 29, 2015, and Aug 17, 2016, we randomly assigned 258 patients to one of the five study groups. At the end of 12 weeks, the least squares mean change in HbA1c from baseline was −0·35% (95% CI −0·60 to −0·10) in the placebo group, −0·39% (−0·64 to −0·14) in the 75 mg once daily group, −0·65% (−0·92 to −0·38) in the 100 mg once daily group, −0·79% (−1·06 to −0·52) in the 50 mg twice daily group, and −1·12% (−1·39 to −0·86) in the 75 mg twice daily group. Compared with the placebo group, the 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) groups. The number of adverse events was similar between the treatment groups and the placebo group. There were no reports of drug-related serious adverse events or severe hypoglycaemia.InterpretationDorzagliatin had a beneficial effect on glycaemic control and was safe and well tolerated over 12 weeks in Chinese patients with type 2 diabetes.FundingHua Medicine, National Major Scientific and Technological Special Project for Significant New Drugs Development, Shanghai Science and Technology Innovation Action Project, Shanghai Pudong District Science and Technology Innovation Action Project, and Shanghai Municipal Commission of Economy and Informatisation Innovation Action Project.
Source: The Lancet Diabetes and Endocrinology - Category: Endocrinology Source Type: research