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. 2025 Jan-Feb;39(1):375-380.
doi: 10.21873/invivo.13838.

Safety and Efficacy of Imeglimin for Type 2 Diabetes Mellitus in Patients With Heart Failure

Tomoaki Nishikawa  1 , Akinori Higaki  2 , Keisho Kurokawa  2 , Kohei Yoshimoto  2 , Rikako Horie  2 , Yasuhisa Nakao  2 , Tomoki Fujisawa  2 , Shigehiro Miyazaki  2 , Yusuke Akazawa  2 , Toru Miyoshi  2 , Hiroshi Kawakami  2 , Haruhiko Higashi  2 , Shunsuke Tamaki  2 , Kazuhisa Nishimura  2 , Katsuji Inoue  2 , Shuntaro Ikeda  2 , Osamu Yamaguchi  2
Affiliations

Safety and Efficacy of Imeglimin for Type 2 Diabetes Mellitus in Patients With Heart Failure

Tomoaki Nishikawa et al. In Vivo. 2025 Jan-Feb.

Abstract

Background/aim: Imeglimin, a novel oral antidiabetic agent, was approved in 2021 for the treatment of type 2 diabetes mellitus (T2DM). Phase III clinical trials demonstrated its safety and efficacy in managing T2DM. However, its safety profile in patients with heart failure has not been thoroughly evaluated in real-world clinical settings.

Patients and methods: We analyzed cases of patients with heart failure (stage B or higher) who were newly prescribed imeglimin, based on electronic medical records from June 2022 to June 2024. Baseline clinical data at the initiation of imeglimin therapy were collected, and cardiovascular events, adverse effects (e.g., lactic acidosis), and blood test results, including glycated hemoglobin A1c (HbA1c), were assessed as of July 2024.

Results: A total of 21 patients met the inclusion criteria. HbA1c levels significantly decreased after an average of 312.1±205.8 days of imeglimin therapy (baseline vs. on therapy: 8.2±1.0% vs. 7.5±0.7%, p=0.001). Alanine aminotransferase levels were also significantly reduced (baseline vs. on therapy: 30.9±23.8 IU/l vs. 22.0±12.3 IU/l, p=0.022). No adverse drug reactions were observed during the treatment period. Major adverse cardiovascular events occurred in three patients (14%), although a clear association with imeglimin remains uncertain.

Conclusion: Imeglimin demonstrated safety and efficacy in T2DM in patients with coexisting heart failure.

Keywords: ALT; AST; HbA1c; Imeglimin; heart failure; lactic acidosis; type 2 diabetes.

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Conflict of interest statement

AH received a lecture fee from Sumitomo Pharma Co., Ltd.

Figures

Figure 1
Figure 1
Comparison of laboratory data in the overall study population (n=21). Box plots showing the levels of (A) hemoglobin A1c (HbA1c), (B) estimated glomerular filtration rate (eGFR), (C) aspartate aminotransferase (AST), and (D) alanine aminotransferase (ALT) before and during imeglimin treatment. The center horizontal line represents the median, the box indicates the interquartile range (25th to 75th percentile), the whiskers extend to the 5th and 95th percentiles, and × denotes the mean value.
Figure 2
Figure 2
Comparison of laboratory data in the population with stage B heart failure (n=12). Box plots showing the levels of (A) hemoglobin A1c (HbA1c), (B) estimated glomerular filtration rate (eGFR), (C) aspartate aminotransferase (AST), and (D) alanine aminotransferase (ALT) before and during imeglimin treatment in patients with stage B heart failure. The center horizontal line represents the median, the box indicates the interquartile range (25th to 75th percentile), the whiskers extend to the 5th and 95th percentiles, and × denotes the mean value.
Figure 3
Figure 3
Pre-post comparison of laboratory data in the population with stage C heart failure (n=9). Box plots showing the levels of (A) hemoglobin A1c (HbA1c), (B) estimated glomerular filtration rate (eGFR), (C) aspartate aminotransferase (AST), and (D) alanine aminotransferase (ALT) before and during imeglimin treatment in patients with stage C heart failure. The center horizontal line represents the median, the box indicates the interquartile range (25th to 75th percentile), the whiskers extend to the 5th and 95th percentiles, and × denotes the mean value.
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