Diabetes remission in drug‐naïve patients with type 2 diabetes after dorzagliatin treatment: A prospective cohort study

Abstract Aim To investigate the post‐treatment effect of dorzagliatin in drug‐naïve patients with type 2 diabetes (T2D) regarding the achievement of stable glycaemic control and drug‐free diabetes remission. Materials and Methods Patients who completed dorzagliatin treatment in the SEED trial and achieved stable glycaemic control were enrolled in this 52‐week study without any antidiabetic medication. The primary endpoint was the diabetes remission probability at week 52 using the Kaplan–Meier method. The potential factors that contribute to stable glycaemic control and diabetes remission based on the characteristics of patients before and after treatment with dorzagliatin were analysed. A post hoc sensitivity analysis of diabetes remission probability using the American Diabetes Association (ADA) definition was conducted. Results The Kaplan–Meier remission probability was 65.2% (95% CI: 52.0%, 75.6%) at week 52. Based on the ADA definition, the remission probability was 52.0% (95% CI: 31.2%, 69.2%) at week 12. The significant improvements in the insulin secretion index ΔC30/ΔG30 (41.46 ± 77.68, P = .0238), disposition index (1.22 ± 1.65, P = .0030), and steady‐state variables of HOMA2‐β (11.49 ± 14.58, P < .0001) and HOMA2‐IR (−0.16 ± 0.36, P = .0130) during the SEED trial were important factors in achieving drug‐free remission. A significant improvement in time in range (TIR), a measure of glucose homeostasis, in the SEED trial from 60% to more than 80% (estimated treatment difference, 23.8%; 95% CI: 7.3%, 40.2%; P = .0084) was observed. Conclusions In drug‐naïve patients with T2D, dorzagliatin treatment leads to stable glycaemic control and drug‐free diabetes remission. Improvements in β‐cell function and TIR in these patients are important contributors to diabetes remission.