Weekly Fixed-Dose Insulin Efsitora in Type 2 Diabetes without Previous Insulin Therapy

作者：Julio Rosenstock, Timothy S. Bailey, Lisa Connery, Eden Miller, Cyrus Desouza, Qianqian Wang, Jennifer Leohr, Alastair Knights, Molly C. Carr, Christopher J. Child · 发表于：New England Journal of Medicine · 年份：2025 · DOI：10.1056/nejmoa2502796 · 被引用次数：28 · 研究领域：Diabetes Management and Research、Diabetes, Cardiovascular Risks, and Lipoproteins、Diabetes Treatment and Management

BACKGROUND: In previous treat-to-target trials, adjustments to the dose of basal insulin have been made at least weekly, according to fasting blood glucose levels. A fixed-dose regimen of insulin efsitora alfa (efsitora), a once-weekly basal insulin, may provide a benefit in adults with type 2 diabetes who have not received previous insulin therapy. METHODS: We conducted a 52-week, phase 3, open-label, treat-to-target trial involving adults with type 2 diabetes who had not previously received insulin therapy. Participants were randomly assigned in a 1:1 ratio to receive once-weekly efsitora or once-daily insulin glargine U100 (glargine). Treatment with efsitora was initiated as a single dose of 100 U administered once weekly, with dose adjustments made every 4 weeks, as needed, at fixed doses of 150, 250, and 400 U to achieve fasting blood glucose levels of 80 to 130 mg per deciliter. Doses of glargine were adjusted weekly or more often according to a standard algorithm to reach the same glycemic goals. The primary end point, tested for noninferiority (noninferiority margin, 0.4 percentage points), was the change from baseline in the glycated hemoglobin level at 52 weeks. RESULTS: A total of 795 participants underwent randomization. The mean glycated hemoglobin level decreased from 8.20% at baseline to 7.05% at week 52 with efsitora (least-squares mean change, -1.19 percentage points) and from 8.28% to 7.08% with glargine (least-squares mean change, -1.16 percentage points); ...