The trial comprised 795 type 2 diabetes adults who had never been treated with insulin therapy. Participants were randomly assigned in a ratio of 1:1 to receive once-weekly efsitora or once-daily glargine U100. Dosing with efsitora was initiated at a dose of 100 units weekly and could be increased every 4 weeks to fixed doses of 150, 250, or 400 units according to fasting blood glucose. Conversely, glargine dosages were titrated more often, weekly or more frequently, based on a standard titration algorithm to achieve the same glucose targets. The main aim was to measure the 52-week change in HbA1c with a noninferiority margin of 0.4 percentage points.
Results
• The mean baseline HbA1c was 8.20% in the efsitora group and 8.28% in the glargine group.
• At the end of 52 weeks, HbA1c levels were reduced to 7.05% with efsitora and to 7.08% with glargine.
• The least-squares mean change was −1.19 percentage points for efsitora and −1.16 percentage points for glargine.
• The estimated between-group difference of −0.03 percentage points (95% confidence interval: −0.18 to 0.12) established that efsitora was noninferior to glargine.
• Superiority was not shown (P=0.68). Efsitora also had benefits regarding safety and ease of use.
• The incidence of clinically significant or severe hypoglycemia was less with efsitora (0.50 events per participant-year) than with glargine (0.88 events per participant-year), with an estimated rate ratio of 0.57 (95% CI: 0.39 to 0.84).
• Furthermore, efsitora patients needed fewer dose adjustments during the year, a median of 2 adjustments versus 8 in the glargine group.
Weekly Dose and Burden of Treatment
• At week 52, the median total weekly insulin dose was 289.1 units with efsitora compared with 332.8 units with glargine, with an estimated between-group difference of −43.7 units per week (95% CI: −62.4 to −25.0).
Weekly efsitora, given as a fixed-dose insulin regimen, was noninferior to daily glargine in lowering HbA1c in adults with type 2 diabetes who had not used insulin before. The results indicate that efsitora could provide an uncomplicated and effective option compared to standard daily insulin regimens, with a lower incidence of hypoglycemia and less need for dose adjustments, potentially enhancing patient adherence and quality of life when treating type 2 diabetes.
Reference:
Rosenstock, J., Bailey, T., Connery, L., Miller, E., Desouza, C., Wang, Q., Leohr, J., Knights, A., Carr, M. C., & Child, C. J. (2025). Weekly fixed-dose insulin efsitora in type 2 diabetes without previous insulin therapy. The New England Journal of Medicine. https://doi.org/10.1056/nejmoa250279
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