Transition from Basal Bolus to Once-Weekly Subcutaneous Semaglutide and Basal Insulin in Patients with Type 2 Diabetes Mellitus (TRANSITION-T2D)-A Prospective Randomized Controlled Trial

Background: The treatment of type 2 diabetes (T2D) with multiple daily injections of insulin (MDI) is associated with a significant burden of disease management, along with a high risk of hypoglycemia and weight gain. Objective: To test the ability of once-weekly subcutaneous (sc) semaglutide to safely replace prandial insulin in patients with T2D adequately controlled on a regimen of MDI. Methods: This is a single-center, open-label, randomized controlled trial. Sixty subjects aged 18 to 75, with an HbA1c ≤ 7.5% on MDI (+/-metformin and/or SGLT-2i) were randomized 2:1 to insulin degludec + semaglutide 1.0 mg or to continue MDI with degludec + insulin aspart for 26 weeks. For the intervention arm, prandial insulin was stopped on the same day of the first dose of semaglutide. Semaglutide was initiated at 0.25 mg sc weekly, and increased monthly, as tolerated. The primary outcome was the percentage of subjects maintaining an HbA1c ≤ 7.5% at week 26. Secondary outcomes were mean change in HbA1c, weight, daily insulin requirement, and diabetes treatment satisfaction from baseline to week 26; the cumulative number of hypoglycemic events and percentage of subjects needing to resume prandial insulin through week 26. Results and conclusions: To be presented at the 2023 ADA scientific sessions. Disclosure P. Rodriguez: None. K. M. Pantalone: Consultant; AstraZeneca, Bayer Inc., Corcept Therapeutics, Diasome, Eli Lilly and Company, Merck & Co., Inc., Novo Nordisk, Sanofi, Research Support; Bayer Inc., Merck & Co., Inc., Novo Nordisk, Twin Health, Speaker's Bureau; AstraZeneca, Corcept Therapeutics, Merck & Co., Inc., Novo Nordisk. N. Breslaw: None. J. F. Bena: None. H. Xiao: None. K. Jenkins: None. D. Isaacs: Speaker's Bureau; Dexcom, Inc., Abbott, Eli Lilly and Company, Medtronic, Novo Nordisk. K. Zhou: None. M. L. Griebeler: None. B. Burguera: Research Support; Novo Nordisk. Funding Novo Nordisk