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Effectiveness and safety of imeglimin in routine clinical practice among Indian patients with type 2 diabetes mellitus: a prospective, non-interventional, real-world observational study (INDI-TIMES 2.0)

Year: 2026

Type: article

Abstract: Introduction: class of glucose-lowering medication. Clinical trials have demonstrated that imeglimin is effective and well-tolerated in patients with Type 2 Diabetes Mellitus (T2DM). This prospective, non-interventional, single-arm, open-label, multi-center observational study evaluates the effectiveness and safety of imeglimin in routine clinical practice in India. Methods: The study was conducted across 145 centers in India. Adults (≥18 years) with T2DM who were prescribed imeglimin 1000 mg twice daily, either as monotherapy or as add-on therapy, were enrolled and followed for 16 weeks. The primary endpoint was the change in glycated hemoglobin (HbA1c) from baseline to Week 16. Secondary endpoints included changes in fasting blood glucose (FBG), postprandial blood glucose (PPBG), and safety outcomes. Results: Of 2,705 screened, 2,704 participants with T2DM were included in the analysis. Mean HbA1c decreased significantly from 8.78% (SD 1.16) at baseline to 7.38% (SD 0.98) at Week 16, with a mean reduction of -1.40% (SD 0.99; p < 0.0001). Significant reductions were also observed in FBG (-46.1 mg/dL) and PPBG (-72.0 mg/dL) from baseline to Week 16 (both p < 0.0001). Improvements in HbA1c levels were consistent across age and gender subgroups. No adverse events (AEs) were reported among participants with the available safety data. Conclusion: These findings demonstrate that imeglimin 1000 mg twice daily was associated with clinically meaningful improvements in glycemic control over 16 weeks and was generally well tolerated, supporting its effectiveness and safety for the management of T2DM in real-world settings.

Source: Frontiers in Endocrinology

DOI: 10.3389/fendo.2026.1973270