Real-world effectiveness and safety of imeglimin in Japanese patients with type 2 diabetes: a retrospective observational study
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Masahiko Kimura1,2, Masashi Yoshida3, Hodaka Yamada3
1Department of Pharmacy, Jichi Medical University Saitama Medical Center, 1-847 Amanuma-cho, Omiya-ku, Saitama, 330-8503 Japan.
Abstract:
Imeglimin is a novel antidiabetic drug that has demonstrated efficacy and safety in clinical trials; however, real-world evidence remains limited. This study retrospectively investigated the efficacy and safety of imeglimin in real-world settings. Patients who received imeglimin for ≥ 6 months without switching to other antidiabetic drugs were enrolled. Monthly changes in glycated hemoglobin (HbA1c) and glycated albumin (GA) concentrations from baseline to 6 months were assessed using a linear mixed model. Subgroup analyses were performed by classifying patients based on age, sex, body mass index, diabetes duration, number of concomitant antidiabetic drugs, baseline HbA1c, type of incretin-based drugs, and chronic kidney disease stage. Baseline and 6-month biomarkers were also compared. Fifty-four patients were included. The mean duration of diabetes was 14 years, and patients were taking an average of 2.9 antidiabetic medications. HbA1c and GA concentrations markedly decreased after initiation, and this change remained significant at 6 months. Subgroup analysis revealed that HbA1c concentration markedly decreased at 6 months in all groups, with no notable differences. Compared to baseline, aspartate aminotransferase, alanine aminotransferase, red blood cells, and hemoglobin concentrations markedly decreased at 6 months. No significant changes were observed in the estimated glomerular filtration rate, weight, and lipid parameters. Among patients who continued imeglimin for 6 months without changes in concomitant antidiabetic therapy, HbA1c and GA improved, with no major safety signals identified. These findings suggest that add-on imeglimin may contribute to improved glycemic control in patients able to continue treatment without regimen modification.
Supplementary Information:
The online version contains supplementary material available at 10.1007/s13340-026-00924-3.
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