Once-weekly Basal Insulin Fc versus daily insulin degludec for glycemic control in diabetes: a systematic review, meta-analysis, and meta-regression.

IF 1.6 Q4 ENDOCRINOLOGY & METABOLISM

Journal of Diabetes and Metabolic Disorders Pub Date : 2025-03-20 eCollection Date: 2025-06-01 DOI:10.1007/s40200-025-01602-y

Sandesh Raja, Adarsh Raja, Azzam Ali, Muhammad Sohaib Asghar

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引用次数: 0

Abstract

Introduction: Diabetes management often requires insulin therapy, yet adherence to daily injections can be challenging due to complexity, injection pain, and fear of hypoglycemia. Basal Insulin Fc (BIF) is a novel once-weekly insulin analog designed to simplify regimens, improve adherence, and enhance glycemic control. This meta-analysis evaluates the efficacy and safety of BIF compared to once-daily insulin degludec.

Methods: A systematic search of PubMed, Google Scholar, EBSCO, ScienceDirect, and the Cochrane Library, along with ClinicalTrials.gov, was conducted up to November 2024 to identify RCTs comparing BIF with insulin degludec. The search employed MeSH terms like "type 1 diabetes mellitus," "type 2 diabetes mellitus," "once weekly basal insulin Fc," and "insulin degludec." Studies were screened in accordance with PRISMA guidelines, and data on glycemic outcomes, safety, and patient demographics were extracted. Statistical analysis included pooled mean differences (MD) and risk ratios (RR) with 95% confidence intervals (CIs) using random-effects models. Heterogeneity was assessed using the I² statistic, and sensitivity analyses were conducted for cases of high heterogeneity. Subgroup and meta-regression analyses assessed moderators such as diabetes type, insulin status, follow-up duration, and heterogeneity.

Results: Five RCTs with 2,562 participants (Type 1 and Type 2 diabetes) were included. BIF showed non-inferiority to degludec in HbA1c reduction (MD 0.03, p = 0.37) and percentage time in range (MD 0.56, p = 0.27). No significant differences were observed in self-monitored fasting blood glucose (MD 2.73, p = 0.40) or clinically significant hypoglycemia (RR 1.00, p = 0.95). However, BIF increased time spent below range (MD 0.30, p = 0.0004) and was associated with higher treatment-emergent adverse events (RR 1.12, p = 0.006). The subgroup analysis highlighted differences in hypoglycemia risks between Type 1 and Type 2 diabetes.

Conclusion: BIF offers comparable glycemic control to insulin degludec while reducing injection frequency, potentially enhancing adherence. However, increased hypoglycemia risks in certain subgroups and higher adverse event rates warrant further evaluation.

Supplementary information: The online version contains supplementary material available at 10.1007/s40200-025-01602-y.

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每周一次基础胰岛素 Fc 与每日胰岛素 degludec 对糖尿病血糖控制的比较：系统综述、荟萃分析和荟萃回归。

糖尿病管理通常需要胰岛素治疗，但由于复杂性、注射疼痛和对低血糖的恐惧，坚持每日注射可能具有挑战性。基础胰岛素Fc （BIF）是一种新的每周一次的胰岛素类似物，旨在简化方案，改善依从性，并加强血糖控制。本荟萃分析评估了BIF与每日1次降葡萄糖胰岛素相比的有效性和安全性。方法：系统检索PubMed，谷歌Scholar， EBSCO, ScienceDirect, Cochrane Library，以及ClinicalTrials.gov，直到2024年11月，以确定比较BIF和胰岛素degludec的rct。搜索使用的MeSH术语包括“1型糖尿病”、“2型糖尿病”、“每周一次的基础胰岛素Fc”和“去葡萄糖糖胰岛素”。根据PRISMA指南筛选研究，并提取血糖结局、安全性和患者人口统计数据。统计分析采用随机效应模型，采用95%置信区间（ci）合并平均差异（MD）和风险比（RR）。采用I2统计量评估异质性，对异质性高的病例进行敏感性分析。亚组和荟萃回归分析评估了糖尿病类型、胰岛素状态、随访时间和异质性等调节因素。结果：纳入了5项随机对照试验，共有2562名参与者（1型和2型糖尿病）。BIF对糖化血红蛋白的降低（MD为0.03,p = 0.37）和作用时间百分比（MD为0.56,p = 0.27）无劣效性。自我监测空腹血糖（MD 2.73, p = 0.40）和临床显著低血糖（RR 1.00, p = 0.95）无显著差异。然而，BIF增加了低于范围的时间（MD为0.30,p = 0.0004），并与更高的治疗不良事件相关（RR为1.12,p = 0.006）。亚组分析强调了1型和2型糖尿病之间低血糖风险的差异。结论：BIF在降低注射频率的同时，提供了与去糖葡萄糖胰岛素相当的血糖控制，潜在地增强了依从性。然而，某些亚组的低血糖风险增加和不良事件发生率较高值得进一步评估。补充资料：在线版本提供补充资料，网址为10.1007/s40200-025-01602-y。

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来源期刊

Journal of Diabetes and Metabolic Disorders Medicine-Internal Medicine

CiteScore

4.80

自引率

3.60%

发文量

210

期刊介绍： Journal of Diabetes & Metabolic Disorders is a peer reviewed journal which publishes original clinical and translational articles and reviews in the field of endocrinology and provides a forum of debate of the highest quality on these issues. Topics of interest include, but are not limited to, diabetes, lipid disorders, metabolic disorders, osteoporosis, interdisciplinary practices in endocrinology, cardiovascular and metabolic risk, aging research, obesity, traditional medicine, pychosomatic research, behavioral medicine, ethics and evidence-based practices.As of Jan 2018 the journal is published by Springer as a hybrid journal with no article processing charges. All articles published before 2018 are available free of charge on springerlink.Unofficial 2017 2-year Impact Factor: 1.816.