1845-P: Efficacy and Safety of Simplified SGLT2i-Based Stepwise Intensive Therapy in Inducing of Diabetes Remission in Newly Diagnosed Type 2 Diabetes with Severe Hyperglycemia: A Pilot Study

Introduction and Objective: Short-term intensive insulin therapy(SIIT) is able to induce remission in T2DM, but traditional inpatient strategy is limited by prolonged hospital stays(2-3 weeks). This pilot study aimed to explore the efficacy and safety of a SGLT-2i-based stepwise intensive therapy in achieving drug-free remission in newly diagnosed T2DM patients. Methods: This pilot randomized controlled trial enrolled 60 newly diagnosed T2DM patients, randomized 1:1 to the stepwise intensive group (Group A, n=30) or conventional SIIT group (Group B, n=30). Group A received inpatient SIIT to achieved nearnormoglycemia (FBG<6.0 mmol/L, 2hBG<7.8 mmol/L) for 3 days, followed by 8-week outpatient therapy with insulin glargine, Henagliflozin (10 mg/d), metformin (up-titrated to 1.5 g/d or maximum tolerance), and remote lifestyle management. Group B received 2-3 week inpatient SIIT. All patients were followed up for 24 weeks post intervention. The primary endpoint was diabetes remission rate (HbA1c<6.5%) at week 24. Results: A total of 57 patients (Group A: 29, Group B: 28) completed the study. Baseline characteristics were balanced between groups, with mean HbA1c of 10.5±1.5%. At week 24, the remission rate was 48.3% (95% CI: 31.4%-65.6%) in Group A and 46.4% (95% CI: 29.5%-65.7%) in Group B (P=0.95). Group A showed superior insulin sensitivity (Matsuda index: 6.5 [5.6,7.5] vs. 4.5 [3.4,5.6], P=0.01; HOMA-IR: 2.3 [1.5,3.0] vs. 4.5 [3.7,5.4], P<0.01), and reduced BMI (24.4±0.8 vs. 25.7±0.8 kg/m², P=0.02) versus Group B. Improvements of β-cell function was observed in both groups without statistical significance. No serious adverse events or treatment discontinuations occurred. Conclusion: This pilot study demonstrates that SGLT-2i-based stepwise intensive therapy achieves comparable 24-week remission rates to conventional SIIT, with advantages in improving insulin sensitivity and weight reduction. Disclosure L. Liu: None. W. Ke: None. S. Tang: None. X. Wan: None. L. Xu: None. J. Liu: None. Z. Zheng: None. Y. Li: None.