Dalong Zhu, Y. Zhang, Li Chen
Jun 1, 2020
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Influential Citations
2
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Quality indicators
Journal
Diabetes
Abstract
GK acts as a ’glucose sensor’ to regulate glucose homeostasis. Dorzagliatin is a novel dual-acting allosteric GKA targeting both pancreatic and liver GK. The study aimed to confirm the efficacy and safety of dorzagliatin as a monotherapy in Chinese T2D patients. It is the first successful Phase III trial for a GKA. It was a multicenter, randomized, double-blind, placebo-controlled trial. 463 drug-naive adult subjects were randomized to 75 mg dorzagliatin or placebo (2:1) BID for 24 wks. The primary endpoint was the change in HbA1c from baseline to wk 24. Secondary endpoints included 2h PPG and other glycemic variables. Safety assessment included AE, hypoglycemia, laboratory tests, ECG, etc. The MMRM results suggested the LS mean change in HbA1c from baseline at wk 24 was -1.07% in dorzagliatin group, significantly lower than the placebo group (P Disclosure D. Zhu: None. Y. Zhang: None. L. Chen: None.