Chen Binbin, Tao Lanqiu, Tian Min, Ji Zhaohua
Department of Gastroenterology, Xijing Hospital,Air Force Medical University, Xi'an 710032, China.
Department of Thyroid and Breast, Division of General Surgery, Shanghai Tenth People's Hospital, Tongji University School of Medicine, Shanghai 200072, PR China.
Clin Nutr ESPEN. 2025 Apr;66:564-572. doi: 10.1016/j.clnesp.2025.01.056. Epub 2025 Jan 30.
BACKGROUND & AIMS: Semaglutide has demonstrated efficacy in both glycemic control and weight loss. This systematic review and meta-analysis aimed to assess the efficacy and safety of the combined use of semaglutide and basal insulin in individuals diagnosed with type 2 diabetes mellitus (T2DM).
PubMed, Cochrane Library, Web of Science, China National Knowledge Infrastructure (CNKI), and China Science and Technology Journal Database (VIP) were searched to identify relevant publications. The primary outcome measure was the change in HbA1c levels. Secondary outcome measures encompassed change in body weight, fluctuations in FPG levels, occurrence of adverse events, serious adverse events, hypoglycemic episodes, and gastrointestinal reactions including nausea, vomiting, and diarrhea. Mean differences (MDs) and relative risk (RR) with confidence intervals (CI) of 95 % were used to analyze the deference.
7 RCTs with 2354 patients were incorporated into the study. Compared to placebo or other active treatment, the addition of semaglutide to basal insulin demonstrated significant reductions in hemoglobin A1c (HbA1c) [mean differences (MD): -1.17 %, P < 0.00001], body weight [MD -5.99 kg, P < 0.00001], and fasting blood glucose (FPG) [MD -1.08 %, P < 0.00001]. No evidence indicated a higher risk of adverse events [RR 1.46, P = 0.13]. However, it did result in increased rates of gastrointestinal adverse events, including nausea, vomiting and diarrhea.
The combination treatment of semaglutide and basal insulin demonstrates significant improvements in glycemic control and reduction in body weight, without an increased risk of hypoglycemia. Our findings provided support for the utilization of a combination therapy involving semaglutide and basal insulin in T2DM.
司美格鲁肽已在血糖控制和体重减轻方面显示出疗效。本系统评价和荟萃分析旨在评估司美格鲁肽与基础胰岛素联合使用对2型糖尿病（T2DM）患者 的疗效和安全性。
检索了PubMed、Cochrane图书馆、科学网、中国知网和维普中文科技期刊数据库，以确定相关出版物。主要结局指标是糖化血红蛋白（HbA1c）水平的变化。次要结局指标包括体重变化、空腹血糖（FPG）水平波动、不良事件、严重不良事件、低血糖发作的发生情况，以及包括恶心、呕吐和腹泻在内的胃肠道反应。采用95%置信区间（CI）的平均差（MD）和相对风险（RR）来分析差异。
该研究纳入了7项随机对照试验，共2354例患者。与安慰剂或其他活性治疗相比，在基础胰岛素中添加司美格鲁肽可显著降低糖化血红蛋白（HbA1c）[平均差（MD）：-1.17%，P<0.00001]、体重[MD -5.99kg，P<0.00001]和空腹血糖（FPG）[MD -1.08%，P<0.00001]。没有证据表明不良事件风险更高[RR 1.46，P=0.13]。然而，它确实导致胃肠道不良事件发生率增加，包括恶心、呕吐和腹泻。
司美格鲁肽与基础胰岛素联合治疗在血糖控制方面有显著改善，体重减轻，且低血糖风险没有增加。我们的研究结果为司美格鲁肽与基础胰岛素联合治疗T2DM的应用提供了支持。
