Annals of medicine and surgery (2012) · 2026 · 系統性回顧＋統合分析（依標題推測）
Efficacy and safety of once-weekly insulin efsitora alfa versus daily basal insulin analogs in type 2 diabetes: a systematic review and meta-analysis.
代謝・營養・內分泌 · 第二型糖尿病
中文閱讀摘要
系統性回顧與統合分析顯示，每週一次insulin efsitora alfa在HbA1c降低及安全性上與每日基礎胰島素相當，但需更多長期試驗確認。
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原始摘要
Background
Type 2 diabetes mellitus (T2DM) often progresses to require basal insulin therapy. Despite the efficacy of once-daily basal insulins such as glargine and degludec, daily injections remain a barrier to adherence. Insulin efsitora alfa, a novel once-weekly fragment crystallizable (Fc)-fusion basal insulin, may improve treatment convenience while maintaining glycemic control.
Objective
To evaluate the efficacy and safety of once-weekly insulin efsitora alfa compared with once-daily basal insulin analogs in adults with T2DM.
Methods
An updated systematic review and meta-analysis was conducted according to PRISMA 2020 guidelines and registered in PROSPERO (CRD420251118205). PubMed, Embase, and CENTRAL were searched up to 30 July 2025 for randomized controlled trials (RCTs) comparing insulin efsitora alfa with once-daily basal insulins. Pooled analyses were performed using a random-effects model in RevMan 5.4. Risk of bias was assessed with the Cochrane RoB-2 tool, and evidence certainty with the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach.
Results
Six RCTs comprising 4115 participants were included. Once-weekly insulin efsitora showed non-inferior HbA1c reduction compared with daily basal insulin (mean difference = -0.04; 95% confidence interval: -0.13 to 0.05; P = 0.35). No significant differences were observed in fasting serum glucose or body weight change. Incidents of level 1, level 2 (clinically significant), and level 3 (severe) hypoglycemia, as well as adverse and serious adverse events, were comparable between groups.
Conclusion
Once-weekly insulin efsitora alfa demonstrates comparable efficacy and safety to daily basal insulin. However, further large-scale, long-term trials are warranted to confirm its durability, safety, and real-world effectiveness.
至 Europe PMC 閱讀完整來源 ↗ · 擷取日期 2026-10-19
書目、來源與全文狀態
- DOI
- 10.1097/ms9.0000000000005075
- PMID／PMCID
- 42254228 / PMC13236254
- 作者
- Khan BW, Fatima M, Amir R, Junejo R, Nawaz S, Ullah G, Ul-Hayya A, Ahmed A, Shaikh RA, Ullah I, Ud Din S, Qamar A, Shahreyar M, Bhattarai P
- 首次發表日期
- 2026-05-07Europe PMC 提供，部分日期可能依年份或月份推定。
- 卷／期／頁碼或文章編號
- 88 ／ 6 ／ 3512-3521
- 書目來源與查核日期
- Europe PMC · 2026-10-19僅核對書目欄位與來源連結；不代表已評讀研究品質。
- 全文與授權
- 來源列有免費全文（查核 2026-10-19），未逐篇測試 PDF 下載。 來源授權標示：cc by。
可回溯引用
Khan BW, Fatima M, Amir R, Junejo R, Nawaz S, Ullah G, Ul-Hayya A, Ahmed A, Shaikh RA, Ullah I, Ud Din S, Qamar A, Shahreyar M, Bhattarai P. Efficacy and safety of once-weekly insulin efsitora alfa versus daily basal insulin analogs in type 2 diabetes: a systematic review and meta-analysis. Annals of medicine and surgery (2012). 2026;88(6):3512-3521. PMID: 42254228. PMCID: PMC13236254. doi:10.1097/ms9.0000000000005075
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