- 2024-12-20
- Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists 31(4)
- Deep Dutta
- Lakshmi Nagendra
- Manoj Kumar
- A B M Kamrul-Hasan
- Saptarshi Bhattacharya
Study Design
- Type
- Meta-Analysis
- Sample size
- n = 2,465
- Population
- subjects with T1D and T2D (2465 subjects from 6 studies)
- Methods
- Meta-analysis of clinical trials; once-weekly efsitora alfa vs once-daily basal insulins
- Duration
- 26-54 weeks
- Funding
- Unclear
Objective
No meta-analysis has holistically analyzed and summarized the efficacy and safety of the novel once-weekly basal insulin efsitora alfa in managing type 1 diabetes (T1D) and type 2 diabetes (T2D).Methods
Clinical trials involving subjects with T1D and T2D receiving once-weekly efsitora alfa in the intervention arm and once-daily basal insulins in the control arm were searched throughout the electronic databases. The primary outcome assessed was the change from baseline in glycated hemoglobin (HbA1c).Results
Data from 6 studies (2465 subjects) were analyzed (follow-up 26-54 weeks). Once-weekly efsitora alfa and once-daily degludec achieved comparable HbA1c reduction in study subjects with T2D (mean difference [MD] 0.02% [-0.11, 0.16]; P = .74) and T1D (MD 0.11% [-0.01, 0.22]; P = .08). Efsitora and degludec were similarly effective in reducing fasting plasma glucose and achieving HbA1c < 7% in subjects with T2D. Individuals with T2D and T1D in the 2 groups had comparable time in range, time above range, and time below range. Subjects with T2D receiving efsitora and once-daily basal insulin had comparable total adverse events, severe adverse events, injection-site reactions, hypersensitivity events, and overall and severe hypoglycemia; however, nocturnal hypoglycemia risk was lower with efsitora (risk ratio 0.85 [0.74, 0.98]; P = .03). However, in individuals with T1D, total adverse events, severe adverse events, and injection-site reactions were higher with efsitora, with comparable risks of hypersensitivity events and overall, severe and nocturnal hypoglycemia.Conclusion
Once-weekly basal insulin efsitora alfa is well tolerated with glycemic efficacy similar to once-daily degludec.