Dorzagliatin for Type 2 Diabetes Mellitus: A Systematic Review and Meta-analysis of Randomized Phase II/III Trials

Clin Ther. 2023 Dec;45(12):1277-1283. doi: 10.1016/j.clinthera.2023.09.011. Epub 2023 Sep 29.

Abstract

Purpose: Dorzagliatin is a glucokinase agonist with effects on type 2 diabetes mellitus (T2DM). This study included a meta-analysis on the efficacy and safety of dorzagliatin in the treatment of T2DM.

Methods: The Cochrane Central Registry of Controlled Trials, PubMed, and Embase were searched from inception to July 25, 2022. A total of 3 studies including 1333 patients were identified in this meta-analysis.

Findings: Overall, the meta-analysis showed that dorzagliatin remarkably reduced glycated hemoglobin levels versus placebo by 0.66%. The results of the meta-analysis showed a significant reduction in fasting plasma glucose of 6.77 mg/dL between dorzagliatin and placebo. In addition, dorzagliatin reduced 2-hour postprandial glucose (2h-PPG) by 43.87 mg/dL compared with placebo. Furthermore, the meta-analysis of available data revealed a significant reduction in the Homeostasis Model Assessment of Insulin Resistance of 0.07 between dorzagliatin and placebo. The risk of adverse events was slightly higher with dorzagliatin than with placebo.

Implications: Dorzagliatin significantly reduced glycated hemoglobin levels, fasting plasma glucose levels, 2h-PPG, and homeostasis model assessment 2 of insulin resistance in patients with T2DM. It was well tolerated and had good liver and kidney safety profiles.

Keywords: Dorzagliatin; Efficacy; Glucokinase agonists; Systematic review; Type 2 diabetes mellitus.

Publication types

  • Meta-Analysis
  • Systematic Review

MeSH terms

  • Blood Glucose
  • Clinical Trials, Phase II as Topic
  • Diabetes Mellitus, Type 2* / drug therapy
  • Glycated Hemoglobin
  • Humans
  • Hypoglycemic Agents / adverse effects
  • Insulin Resistance*
  • Randomized Controlled Trials as Topic

Substances

  • Blood Glucose
  • Dorzagliatin
  • Glycated Hemoglobin
  • Hypoglycemic Agents