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Randomized trial compared treatment satisfaction in insulin-naive adults, indicating IcoSema may enhance patient satisfaction.
Introduction and Objective: COMBINE 4 compared the efficacy and safety of IcoSema, a once-weekly combination of insulin icodec + semaglutide, vs once-daily glargine U100 in insulin-naïve adults with T2D. At week 40, the change from baseline in Diabetes Treatment Satisfaction Questionnaire - status version (DTSQs) total treatment satisfaction score (TTSS) was statistically significantly greater with IcoSema vs glargine U100. Here, we consider individual DTSQs items contributing to the TTSS. Methods: COMBINE 4 was a 40-week, open-label, treat-to-target, phase 3b trial. Adults (≥ 18 years) with T2D (A1C ≥ 8.0%) on oral glucose-lowering medications were randomized 1:1 to IcoSema (n=243) or glargine U100 (n=242). DTSQs was completed at baseline and week 40. Results: At week 40, changes from baseline in all contributing DTSQs item scores were statistically significantly greater with IcoSema vs glargine U100 (Fig. A). The odds of achieving a clinically meaningful change in DTSQs TTSS, and in item scores for convenience and flexibility, were statistically significantly greater with IcoSema vs glargine U100; all other contributing item EORs numerically favored IcoSema (Fig. B). Conclusion: The statistically significantly greater change in DTSQs TTSS in favor of IcoSema vs glargine U100 was driven by improvements in all contributing items. Disclosure L. Chen: Research Support; Current; AstraZeneca, Lilly, Gan & Lee Pharmaceuticals, Novo Nordisk, Sanofi. M. Benamar: Employee; Current; Novo Nordisk A/S. B. Harvey: Employee; Current; Novo Nordisk A/S. S. Kim: None. L. Pletsch Borba: Employee; Current; Novo Nordisk A/S. Stock/Shareholder; Current; Novo Nordisk A/S. P. Fiorina: Board Member; Ended; Novo Nordisk, Lilly, AstraZeneca, Boehringer Ingelheim International GmbH.
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CHEN et al. (2026) studied this question.
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