Safety and Efficacy of Imeglimin in Type 2 Diabetes Individuals with Metformin Intolerance: A Case-Control Study

Objective: Metformin is recommended as first-line treatment for type 2 diabetes (T2D), but its adverse gastrointestinal (GI) effects often lead to discontinuation. Imeglimin, a new drug like metformin, has been approved in several countries. This study evaluates the efficacy and safety of imeglimin in individuals with T2D who are metformin intolerant. Materials and methods: This case-control study, which was conducted for a period of 24 weeks, included 104 metformin intolerant participants comprising 53 cases (individuals on imeglimin and other oral antihyperglycemic agents [OHA]) and 51 controls (individuals on OHAs excluding imeglimin). The primary outcome was the change in HbA1c from baseline to 24 weeks. Secondary outcomes included changes in body weight and safety profile. Statistical analysis was performed using ANOVA and t-tests for continuous variables and chi-square for categorical variables. Results: The mean age of the total sample was 45.9 years (cases 46.8 years, controls 45.1 years). At 24 weeks, the mean HbA1c reduction was 1.0% (8.3–7.3%) in the cases and 0.8% (8.2–7.4%) in the controls. The imeglimin group exhibited a weight-neutral profile (mean difference: 0.1 kg), while the control reported a slight increase in weight (0.5–0.6 kg). Seven cases (13.21%) and 6 controls (11.76%) reported adverse events leading to dose adjustments or symptomatic treatment. Conclusions: Imeglimin shows potential as an effective alternative for glycemic control among metforminintolerant T2D individuals. It offers reduction in HbA1c with minimal impact on weight and a tolerable side effect profile. Further studies are warranted to establish fully the long-term benefits and safety profile.