863-P: A Multicenter, Randomized, Open-Label, Controlled Study on Evaluating the Efficacy and Safety of Switching from Daily DPP-4 Inhibitors to Cofrogliptin in Patients with Type 2 Diabetes Mellitus in China

Introduction and Objective: Cofrogliptin is a novel ultra-long-acting DPP-4 inhibitor (DPP-4i) which could maintain good glycemic control in type 2 diabetes (T2D) patients with 10mg dose once biweekly. This study aims to assess the efficacy and safety of switching daily DPP-4i to cofrogliptin in Chinese T2D patients, focusing on blood glucose fluctuations. Methods: T2D patients previously treated by daily DPP-4i with or without metformin for at least 12 weeks were included. Eligible patients were randomly 1:1 assigned to the daily DPP-4i group (continued their medication) or the cofrogliptin group (switched the daily DPP-4i to biweekly cofrogliptin) for the treatment of 24 weeks. 14-day CGM was conducted from week -2 to 0 and from week 22 to 24. The primary endpoint was the change in time in range (TIR, 3.9-10.0 mmol/L) from baseline to 24 weeks. Results: A total of 64 participants with mean HbA1c of 7.04% and TIR of 83.79% were enrolled. After 24-week treatment, the mean TIR (%) relative to baseline changed by an increase of 0.545 in the cofrogliptin group and a decrease of 9.614 in the daily DPP-4i group. There was a significant difference between the two groups with least-squares (LS) mean difference of 10.159 (95%CI: 3.194, 17.124, P=0.0050). The change in mean glucose (MG, mmol/L) and coefficient of variation (CV, %) from baseline also showed significant difference with LS Mean difference of -1.016 (95%CI: -1.644, -0.388, P=0.0020) and -3.370 (95%CI: -5.998, -0.741, P=0.0129) in favor of the cofrogliptin group. There were no severe hypoglycemia events in both groups and the incidence of adverse events was similar between the two groups. Conclusion: The treatment of switching to cofrogliptin from daily DPP-4i resulted in better maintenance of TIR, MG, and CV in T2D patients, irrespective of metformin co-use, and showed good tolerability and safety. Clinical trial information: NCT06703268. Disclosure C. Pan: None. L. Chen: None. H. Jiang: None. Y. Feng: None. S. Wang: None. J. Zhang: None. Z. Wang: None. Y. Zhou: None.