History of gastrointestinal symptoms with other glucose‐lowering agents is associated with gastrointestinal adverse events after imeglimin initiation: A retrospective real‐world study

Aims/Introduction Imeglimin is an oral antidiabetic agent with a novel mechanism of action. Gastrointestinal (GI) adverse events (AEs) have been reported during imeglimin therapy. However, the factors associated with the occurrence of GI AEs have not been fully elucidated. This study aimed to investigate the incidence of GI AEs and the factors associated with their occurrence following imeglimin initiation. Materials and Methods This retrospective single‐center observational study included patients with type 2 diabetes who initiated imeglimin between September 16, 2021, and June 30, 2025, at our institution. Of the 254 patients who initiated imeglimin, 238 met the eligibility criteria and were included in the analysis. Patients were classified into two groups according to the presence of GI AEs. Baseline characteristics were compared between the groups, and multivariate logistic regression analysis was performed to identify factors associated with GI AEs. Modified Poisson regression with robust error variance was conducted as a sensitivity analysis. Results GI AEs occurred in 77 (32.4%) patients. Multivariate logistic regression analysis showed that a history of GI symptoms associated with glucose‐lowering agents other than imeglimin was independently associated with GI AEs (odds ratio 3.49, 95% CI 1.76–6.94). Modified Poisson regression with robust error variance showed similar results (risk ratio 2.04, 95% CI 1.45–2.88). Conclusions Patients with a history of GI symptoms associated with glucose‐lowering agents other than imeglimin may have a higher risk of developing GI AEs after imeglimin initiation. Incorporating this information into pre‐treatment assessment may support clinical decision‐making at imeglimin initiation.