8613 Diabetes remission: experience from a randomized control trial conducted in a tertiary care hospital in India

Abstract

Abstract Disclosure: A.M. Chakraborty: None. R. Waila: None. S. Bhansali: None. H. Bhujade: None. N. Sachdeva: None. S. Bhadada: None. Introduction: The usual perception and interpretation of diabetes mellitus is that of an irreversible and chronic persistent disease with little scope for remission. Following the success of metabolic surgery and intensive lifestyle modification, it is time for pharmacotherapy to sept in. Methodology: It was a single-center, randomized controlled trial conducted in patients having HbA1c below 9 % at randomization and having a duration of diabetes less than 2 years. Patients with organ-threatening chronic diseases and severe diabetes-related complications have been excluded. Study populations have been randomized to 1:1 to receive pharmacotherapy with oral semaglutide, dapagliflozin, and metformin in one arm and vildagliptin, metformin, and titrated glimepiride in the control arm. Duration of therapy was 6 months including 2 months of up titration of semaglutide. Patients have been followed up for 3 months after stopping all therapy following 6 months of therapy. The primary outcome was to find out the remission rates in patients with Type 2 diabetes mellitus treated with a combination of oral Semaglutide and dapagliflozin on top of metformin monotherapy and to compare with the standard diabetes practice. The secondary outcome was to assess the anthropometric change and change in beta cell function parameters with a mixed meal tolerance test. Results: A total of 38 patients have completed therapy, 17 were in the trial arm and 21 in the control arm. Among 17 patients in the trial arm, all the patients were in remission as per the prespecified criteria. Among the patients who completed 6 months of follow-up (n-13), 11 patients (84%) maintained remission in the trial arm. The remission rate was 100% in the trial arm and 48% in the conventional arm (p<0.001) after 3 months and 84% and 27.7% in the trial arm and conventional arm respectively after 6 months of follow-up (p<0.05). Reduction in BMI (p <0.001) and percent body fat (p<0.01) and increase in disposition index after mixed meal tolerance test (p<0.01) was statistically related to remission. Conclusion: Remission of diabetes as defined by ADA in the consensus statement (HbA1c < 6.5 % without glucose-lowering therapy for at least 3 months) is a reality. It can be achieved by pharmacotherapy targeting body weight and adiposity. The main predictors of remission were a reduction of BMI and body fat and an increased disposition Index. Since it is an ongoing study, further follow-up is planned to determine the continuation of the remission phase among those who achieved remission with pharmacotherapy. Presentation: 6/3/2024