Real-World Effectiveness and Safety of Imeglimin in Type 2 Diabetes: Prospective Multi-Center Study in Bangladesh

Background: This study assessed the real-world effectiveness and safety of imeglimin among Bangladeshi patients with type 2 diabetes mellitus (T2DM). Methods: This prospective, multi-center observational study was conducted across 15 specialized diabetes care centers in Bangladesh from January 2024 to December 2024. Adults with uncontrolled T2DM (HbA1c > 7%) prescribed imeglimin (500– 2000 mg daily) either as monotherapy or combination therapy were enrolled. A total of 898 subjects were assessed at baseline, 3 months, and 6 months. Primary outcomes were changes in HbA1c, fasting plasma glucose (FPG), and postprandial plasma glucose (PPPG). Secondary outcomes included body mass index (BMI), blood pressure, lipids, and safety parameters. Results: The mean age was 46.2 ± 13.1 (SD) years, with 67% being female. Baseline HbA1c decreased from 9.2± 1.4% to 7.1± 1.0% at 6 months (mean change: − 2.1%, p< 0.001). FPG reduced from 9.37± 2.53 to 7.28± 4.63 mmol/L (p< 0.001) and PPPG from 14.36± 3.29 to 8.95± 1.76 mmol/L (p< 0.001). BMI decreased from 28.1± 4.2 to 25.6± 3.6 kg/m 2 (p< 0.001). Significant improvements occurred in blood pressure, lipids, and renal parameters. Adverse events were mild; 3.6% reported ≥ 1 event (gastrointestinal 2.4%, dehydration 1.3%). No serious adverse events occurred. Conclusion: Imeglimin demonstrated substantial glycemic improvements and favorable safety in real-world Bangladeshi patients with poor glycemic control. Keywords: type 2 diabetes mellitus, imeglimin, glycemic control, real-world effectiveness, Bangladesh