Benefits and disadvantages of combination therapy with imeglimin and metformin in patients with type 2 diabetes.

IF 2.5 3区医学 Q3 PHARMACOLOGY & PHARMACY

Expert Opinion on Pharmacotherapy Pub Date : 2025-03-30 DOI:10.1080/14656566.2025.2486354

Hiroyuki Ito, Emiko Tsugami, Chiaki I, Shun Miura, Suzuko Matsumoto, Hideyuki Inoue, Shinichi Antoku, Tomoko Yamasaki, Toshiko Mori, Michiko Togane

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Abstract

Background: We retrospectively examined the benefits and disadvantages of adding imeglimin to metformin therapy in patients with type 2 diabetes.

Research design and methods: Ninety-four patients with type 2 diabetes who had been administered imeglimin were included in the safety analysis set (SAS). Sixty-four patients who had been treated with imeglimin for over 6 months were included in the full analysis set (FAS). The primary outcome was the change in HbA1c levels in the FAS. The secondary outcomes were gastrointestinal adverse events (AEs) in the SAS and changes in body weight and FIB-4 in theFAS.

Results: In the SAS, gastrointestinal AEs occurred in 15 of 40 (38%) metformin users and 6 of 54 (11%) non-users. In the FAS, HbA1c levels were significantly reduced in both metformin users (n = 27, baseline, 8.5 ± 1.1%;6 months, 7.7 ± 1.2%) and non-users (n = 37, baseline, 8.0 ± 0.9%; 6 months,7.4 ± 0.9%). While body weight (from 72.0 ± 20.5 kg to 70.9 ± 20.8 kg) and FIB-4 (from 1.27 ± 0.57 to 1.17 ± 0.49) significantly decreased in metformin users, they did not significantly differ in non-users.

Conclusions: Adding imeglimin to metformin therapy demonstrated favorable reductions in HbA1c, body weight, and FIB-4 in patients with type 2 diabetes, although it was associated with the incidence of gastrointestinal AEs.

Trial registration: UMIN000055241.

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研究背景我们回顾性地研究了在二甲双胍治疗中添加伊迈格列明对2型糖尿病患者的利弊：94名接受过伊迈格列明治疗的2型糖尿病患者被纳入安全性分析组（SAS）。64名接受伊迈格列明治疗超过6个月的患者被纳入全面分析集（FAS）。FAS 的主要结果是 HbA1c 水平的变化。次要结果是 SAS 中胃肠道不良事件（AEs）以及 FAS 中体重和 FIB-4 的变化：结果：在 SAS 中，40 位二甲双胍使用者中有 15 位（38%）出现了胃肠道不良反应，54 位非使用者中有 6 位（11%）出现了胃肠道不良反应。在 FAS 中，二甲双胍使用者（n = 27，基线，8.5 ± 1.1%；6 个月，7.7 ± 1.2%）和非使用者（n = 37，基线，8.0 ± 0.9%；6 个月，7.4 ± 0.9%）的 HbA1c 水平均显著降低。二甲双胍使用者的体重（从 72.0 ± 20.5 千克降至 70.9 ± 20.8 千克）和 FIB-4（从 1.27 ± 0.57 降至 1.17 ± 0.49）显著下降，而非使用者则无显著差异：结论：在二甲双胍治疗的基础上加用伊迈格列明可有效降低2型糖尿病患者的HbA1c、体重和FIB-4，但与胃肠道AEs的发生率有关：试验注册：UMIN000055241。

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来源期刊

Expert Opinion on Pharmacotherapy 医学-药学

CiteScore

5.60

自引率

3.10%

发文量

163

审稿时长

4-8 weeks

期刊介绍： Expert Opinion on Pharmacotherapy is a MEDLINE-indexed, peer-reviewed, international journal publishing review articles and original papers on newly approved/near to launch compounds mainly of chemical/synthetic origin, providing expert opinion on the likely impact of these new agents on existing pharmacotherapy of specific diseases.