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/m2 (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.