763-P: Dorzagliatin Add-On to Metformin Achieved Sustained Efficacy and Good Safety Profiles in T2D Patients in a 52-Week Phase 3 Trial (DAWN)

Metformin, as recommended in various guidelines, is the currently preferred first-line treatment for T2D and often used in combination with other antidiabetic agents. Despite advances in diabetes therapeutics, there was still a lack of improvement in reaching clinical targets. Previous results on dorzagliatin from a monotherapy trial (SEED) have shown sustained efficacy and safety profiles in drug-naive T2D patients over 52 weeks. In this randomized, double-blind, placebo-controlled trial, the efficacy and safety of dorzagliatin add-on to metformin in T2D patients were evaluated. Patients were treated with metformin at 1500 mg/day as basic therapy throughout the 52-week treatment period. A total of 767 eligible Chinese patients were randomized to 75 mg dorzagliatin or placebo (1:1) BID groups for 24 weeks, followed by another 28 weeks with dorzagliatin (75 mg BID) in both groups. The primary endpoint was the change of the HbA1c from baseline at week 24. The HbA1c from baseline was reduced by 1.02% at week 24 in the dorzagliatin group, superior to the placebo (P Disclosure L. Chen: None. Y. Zhang: Employee; Self; Hua Medicine. W. Yang: None.