1799-P: Safety and Efficacy of Dorzagliatin in Patients with Type 2 Diabetes under Real-World Clinical Practice: Preliminary Results from a Large-Scale Post-Marketing Study

Introduction and Objective: Dorzagliatin, the first-in-class glucokinase activator approved in China (2022), offers a novel mechanism for T2DM management. This multicenter study evaluates its long-term safety and real-world effectiveness. Methods: We enrolled 2,024 T2DM patients across 80 Chinese centers receiving dorzagliatin for 52 weeks. Primary endpoints included the incidence of adverse drug reactions (ADRs) and serious adverse events (SAEs) during the 52-week treatment observation period. Secondary endpoints were HbA1c changes after 52 weeks and target response rates (HbA1c <7%) at Week 52. Results: The preliminary analysis included 2,024 T2DM patients (62% male, mean age 55.46 years, BMI 25.06 kg/m², T2DM duration 7.87 years, baseline HbA1c 7.80%) who received dorzagliatin as monotherapy (18%), with metformin (17%), or with insulin (20%). Remarkably, no drug-related SAEs or severe hypoglycemia occurred during the 52-week treatment period. Clinically significant hypoglycemia (blood glucose <3.0 mmol/L) remained <1%. Liver/kidney function and lipid profiles showed no significant changes. HbA1c improved significantly across all groups (overall and subgroups) at Week 52, with substantial target response rates (HbA1c <7%) at Week 52: 61% (dorzagliatin monotherapy) and 45% (combination with metformin). Conclusion: Dorzagliatin demonstrates excellent safety with robust glycemic control across diverse T2DM populations and treatment regimens, supporting its role in real-world clinical practice. Disclosure W. Yang: None. L. Li: None. X. Gao: None. Y. Zhao: None. X. Liu: None. A. Wang: None. J. Chen: None. Y. Tang: None. Y. Zhang: None. L. Chen: None.