1753-P: CGM-Based Metrics in Insulin-Naive Adults with T2D Receiving IcoSema vs. Glargine U100: Post Hoc Analysis of COMBINE 4.

Introduction and Objective: IcoSema is a once-weekly combination therapy of insulin icodec + semaglutide. This post hoc analysis assessed CGM-based metrics of IcoSema vs glargine U100 using blinded CGM data from COMBINE 4, a 40-week, phase 3b trial in T2D. Methods: Adults with T2D inadequately controlled on oral glucose-lowering medications were randomized 1:1 to IcoSema or glargine U100. Time in tight range (TITR, 70-140 mg/dL); achievement of the double composite CGM target (>70% time in range [70-180mg/dL] + <4% time <70 mg/dL); coefficient of variation (CV%); and duration of CGM-based overall hypoglycemic episodes (<70 mg/dL for >=15 consecutive min) were assessed during weeks 36-40. Results: Mean percentage of TITR was statistically significantly higher with IcoSema vs glargine U100 (p<0.0001; Table). Odds of achieving the double composite CGM target were statistically significantly higher with IcoSema vs glargine U100 (p=0.0004). Geometric mean CV% was <36% in both groups, with a numerically higher proportion of participants achieving CV% <36% with IcoSema vs glargine U100. Median duration of overall hypoglycemic episodes was comparable between groups. Conclusion: Compared with glargine U100, IcoSema was associated with improved glycemic control. These findings support IcoSema as a potential once-weekly alternative to daily basal insulin for treatment intensification in insulin-naive adults with T2D. Disclosure C. Irace: Board Member; Ended; Abbott Diabetes. Board Member; Current; Novo Nordisk. Speaker's Bureau; Ended; Medtronic. Board Member; Current; Roche Diabetes Care. Speaker's Bureau; Ended; Novo Nordisk, Lilly. R. Maltesen: Employee; Current; Novo Nordisk. L. Pletsch Borba: Employee; Current; Novo Nordisk A/S. Stock/Shareholder; Current; Novo Nordisk A/S. T.M. Pagliaro Rocha: None. Y. Terauchi: Speaker's Bureau; Current; Astellas Pharma Inc., AstraZeneca, Eli Lilly and Company, Kowa Company, Ltd., Mitsubishi Tanabe Pharma Corporation, Merck Sharp & Dohme Corp., Nippon Boehringer Ingelheim Co. Ltd., Novo Nordisk, Sanofi, Sumitomo Pharma. Research Support; Current; Eli Lilly and Company, Nippon Boehringer Ingelheim Co. Ltd., Sumitomo Pharma. C. Mathieu: Advisory Panel; Current; Abbott Diagnostics, Dexcom, Inc. Board Member; Current; European Association for the Study of Diabetes. Advisory Panel; Current; Novo Nordisk, Eli Lilly and Company, Sanofi, Vertex Pharmaceuticals Incorporated, Medtronic.