Tewari Jay, Qidwai Khalid Ahmad, Tewari Ajoy, Rana Anadika, Singh Vanshika, Tewari Vineeta, Mateen Raghda, Khatoon Sabiha, Ahmad Faraz, Haque Shafiul
King George's Medical University, Lucknow, UP, India.
Aasra Hospital, Lucknow, UP, India.
Naunyn Schmiedebergs Arch Pharmacol. 2025 Apr 30. doi: 10.1007/s00210-025-04198-5.
This systematic review and meta-analysis evaluated the efficacy and safety of Imeglimin in managing type-2 diabetes mellitus (T2DM). A systematic search of PubMed, Embase, and Cochrane Central was conducted up to March 26, 2025. Randomized controlled trials (RCTs) in T2DM subjects with at least two treatment arms were included in the qualitative analysis. Imeglimin, as monotherapy or in combination with other anti-diabetic agents, was compared to placebo or other treatments. Data were independently extracted by three authors, with discrepancies resolved by two other authors. Outcomes were pooled using random-effects or fixed-effects models based on heterogeneity. Thirteen RCTs and nine observational studies were included in the quantitative and qualitative analyses, respectively. Imeglimin significantly reduced glycated haemoglobin/haemoglobin A1c (HbA1c) and fasting plasma glucose (FPG), with greater efficacy at higher doses and in combination therapy. It improved β-cell function (HOMA-β) without significant effects on insulin resistance (HOMA-IR). No major adverse events were reported. However, the studies were limited to Japanese (Asian) and Caucasian populations, affecting generalizability. Significant heterogeneity amongst studies for some outcomes further indicates the need for comprehensive clinical trials with greater sample sizes and uniform dose ranges and follow-up periods. Imeglimin is an effective and safe option for T2DM, particularly for improving glycemic control and β-cell function. Further studies in diverse populations are needed to confirm these findings. Trial Registration: PROSPERO (CRD42024564036).
本系统评价和荟萃分析评估了依美格列明治疗2型糖尿病（T2DM）的疗效和安全性。截至2025年3月26日，对PubMed、Embase和Cochrane Central进行了系统检索。定性分析纳入了至少有两个治疗组的T2DM受试者的随机对照试验（RCT）。将依美格列明作为单一疗法或与其他抗糖尿病药物联合使用，与安慰剂或其他治疗方法进行比较。由三位作者独立提取数据，其他两位作者解决分歧。根据异质性，使用随机效应或固定效应模型汇总结果。定量和定性分析分别纳入了13项RCT和9项观察性研究。依美格列明显著降低糖化血红蛋白/血红蛋白A1c（HbA1c）和空腹血糖（FPG），在高剂量和联合治疗时疗效更佳。它改善了β细胞功能（HOMA-β），而对胰岛素抵抗（HOMA-IR）无显著影响。未报告重大不良事件。然而，这些研究仅限于日本（亚洲）和白种人群体，影响了结果的普遍性。一些结果在研究之间存在显著异质性，这进一步表明需要进行样本量更大、剂量范围和随访期统一的全面临床试验。依美格列明是治疗T2DM的一种有效且安全的选择，特别是在改善血糖控制和β细胞功能方面。需要在不同人群中进行进一步研究以证实这些发现。试验注册：PROSPERO（CRD42024564036）。
