Key result
Imeglimin associated with a ~0.7% HbA1c reduction in T2D and HF without adverse reactions.
Why the study?
The safety profile of imeglimin in patients with heart failure had not been thoroughly evaluated in real-world clinical settings.
Does imeglimin improve glycemic control and remain safe in patients with type 2 diabetes mellitus and coexisting heart failure?
Observational (n=21)
Does imeglimin improve glycemic control and remain safe in patients with type 2 diabetes mellitus and coexisting heart failure?
Absolute Event Rate: 7.5% vs 8.2%
p-value: p=0.001
Imeglimin demonstrated safety and efficacy in reducing HbA1c levels in a small cohort of patients with type 2 diabetes and coexisting heart failure.
May support glycemic benefit of imeglimin in T2DM-HF without safety signals; hypothesis-generating pending randomized confirmation.
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.
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Nishikawa et al. (2024) conducted an observational in Type 2 diabetes mellitus and heart failure (n=21). Imeglimin vs. Baseline was evaluated on HbA1c levels (p=0.001). Imeglimin therapy significantly reduced HbA1c levels from 8.2% to 7.5% (p=0.001) in patients with type 2 diabetes and heart failure, with no adverse drug reactions observed.
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