Li Chen, Y. Zhang, Dalong Zhu
Jun 1, 2021
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Quality indicators
Journal
Diabetes
Abstract
Improvement of glucose and insulin sensitivity in T2D remains as an unfulfilled task for the treatment of underlying cause of disease. Dorzagliatin is a first-in-class antidiabetic drug that acts as a glucose sensitizer, which repairs the sensor function of glucokinase(GK) and improves glucose sensitivity. The study aimed to confirm the efficacy and safety of dorzagliatin as a monotherapy in T2D patients. In this randomized, double-blind, placebo-controlled trial, 463 eligible drug-naive Chinese patients were randomized to 75 mg dorzagliatin or placebo (2:1) twice daily (BID) groups for 24 weeks, followed by the dorzagliatin treatment (75 mg BID) for 28 weeks in both groups. The primary endpoint was the change in the HbA1c from baseline to week 24. The mixed models for repeated measures results suggested that the least squares mean change in HbA1c from baseline at week 24 was -1.07% in the dorzagliatin group, significantly lower than the placebo (P Disclosure L. Chen: None. Y. Zhang: Employee; Self; Hua Medicine. D. Zhu: None.