Masouri Mohammad Mahdi, Ebrahimi Rasoul, Noori Shokoofe
School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Department of Biochemistry, Faculty of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Endocrinol Diabetes Metab. 2025 Jul;8(4):e70060. doi: 10.1002/edm2.70060.
This study aims to perform an updated meta-analysis evaluating the efficacy and safety of metformin adjunct therapy in type 1 diabetes mellitus (T1DM) patients.
Cochrane, PubMed and Embase were searched for randomised controlled trials (RCTs) that reported the efficacy and safety of metformin in T1DM patients. Statistical analyses were performed using STATA software.
Twenty-nine placebo-controlled RCTs enrolling 2051 T1DM patients were included. Adolescents experienced a notable reduction in total insulin daily dose (TIDD) (mean difference [MD] = -0.61 [95% confidence interval (CI): -1.02, -0.20] units/kg per day) and levels of haemoglobin A1c (HbA1c) (MD = -0.45 [95% CI: -0.79, -0.11]), total cholesterol (TC) (MD = -0.78 [95% CI: -1.54, -0.02]), and low-density lipoprotein (LDL) (MD = -0.69 [95% CI: -1.36, -0.02]) at 3 months of follow-up with metformin. In adults, metformin significantly reduced Body Mass Index (BMI) (MD = -0.71 [95% CI: -1.23, -0.19]), TIDD (MD = -0.44 [95% CI: -0.73, -0.16]), and levels of HbA1c (MD = -0.70 [95% CI: -1.10, -0.30]) and TC (MD = -0.60 [95% CI: -1.09, -0.10]) at 6 months. The risk of gastrointestinal adverse events (GIAEs) was significantly higher in both adolescents (Relative Risk [RR] = 1.74 [95% CI: 1.38, 2.21]) and adults (RR = 3.24 [95% CI: 1.49, 7.02]). All of the above had p-values less than 0.05. The metformin group showed no differences in BMI Z-score, high-density lipoprotein (HDL) level, or diabetic ketoacidosis (DKA) risk. No statistical difference was identified for any of the outcomes at other follow-up endpoints.
Metformin may reduce TIDD and levels of HbA1c, TC, triglycerides (TG), and LDL in T1DM adolescents. BMI, TIDD, and levels of HbA1c and TC may decrease in adults. Moreover, it may raise the risk of GIAEs in both age groups.
本研究旨在进行一项更新的荟萃分析，评估二甲双胍辅助治疗1型糖尿病（T1DM）患者的疗效和安全性。
检索Cochrane、PubMed和Embase数据库，查找报告二甲双胍治疗T1DM患者疗效和安全性的随机对照试验（RCT）。使用STATA软件进行统计分析。
纳入了29项安慰剂对照的RCT，共2051例T1DM患者。在接受二甲双胍治疗3个月的青少年中，每日总胰岛素剂量（TIDD）（平均差[MD]=-0.61[95%置信区间（CI）：-1.02，-0.20]单位/千克/天）、糖化血红蛋白（HbA1c）水平（MD=-0.45[95%CI：-0.79，-0.11]）、总胆固醇（TC）（MD=-0.78[95%CI：-1.54，-0.02]）和低密度脂蛋白（LDL）（MD=-0.69[95%CI：-1.36，-0.02]）均显著降低。在成人中，二甲双胍在6个月时显著降低了体重指数（BMI）（MD=-0.71[95%CI：-1.23，-0.19]）、TIDD（MD=-0.44[95%CI：-0.73，-0.16]）、HbA1c水平（MD=-0.70[95%CI：-1.10，-0.30]）和TC（MD=-0.60[95%CI：-1.09，-0.10]）。青少年（相对风险[RR]=1.74[95%CI：1.38，2.21]）和成人（RR=3.24[95%CI：1.49，7.02]）发生胃肠道不良事件（GIAE）的风险均显著更高。上述所有结果的P值均小于0.05。二甲双胍组在BMI Z评分、高密度脂蛋白（HDL）水平或糖尿病酮症酸中毒（DKA）风险方面无差异。在其他随访终点，任何结局均未发现统计学差异。
二甲双胍可能降低T1DM青少年的TIDD以及HbA1c、TC、甘油三酯（TG）和LDL水平。成人的BMI、TIDD以及HbA1c和TC水平可能降低。此外，它可能增加两个年龄组发生GIAE的风险。
