Imeglimin in Indian Adults with Type 2 Diabetes: A Prospective Multicenter Real-world Cohort Study of Prescription Patterns, Glycemic Change, and Safety.

BACKGROUND

Imeglimin is a novel oral glucose-lowering agent targeting mitochondrial dysfunction. While randomized trials demonstrate its efficacy, real-world data in diverse populations remain limited. We evaluated the effectiveness, safety, and utilization patterns of imeglimin in Indian adults with inadequately controlled type 2 diabetes (T2D).

MATERIALS AND

METHODS

This prospective, multicenter, observational cohort study enrolled adults with T2D newly initiated on imeglimin across 11 Indian centers. Participants were followed for 6 months. The primary outcome was the change in HbA1c from baseline. Effectiveness was analyzed in a complete-case cohort using linear mixed-effects models to adjust for covariates, while safety was assessed in all participants with at least one post-baseline evaluation.

FINDINGS: The baseline cohort included 736 participants (mean age 52.4 years, mean baseline HbA1c 9.8%). Imeglimin was predominantly prescribed as an add-on therapy (84.6%), most frequently alongside three or more other agents (57.9%). In the complete-case cohort (n = 337; 46% of baseline), adjusted mean HbA1c decreased by 1.28% (95% CI -1.41 to -1.14) at 3 months and 2.27% (-2.41 to -2.13) at 6 months (p <0.001). Greater reductions were significantly associated with higher baseline HbA1c. Adverse events were reported in 9.9% of the safety cohort (n = 573), most commonly mild gastrointestinal symptoms (5.2%). Hypoglycemia occurred in 1.2%. Two cases of lactic acidosis were reported, though causality with imeglimin was not established.

CONCLUSION

In routine clinical practice, the initiation of imeglimin among Indian adults with T2D was associated with clinically meaningful reductions in HbA1c, fasting plasma glucose, and postprandial glucose over a 6-month period, alongside a favorable safety profile. These real-world findings support the clinical utility and tolerability of imeglimin as an effective therapeutic option for glycemic management in this population. Future randomized controlled trials with extended follow-up are warranted to establish definitive causal treatment effects and evaluate long-term clinical outcomes.