Imeglimin versus Vildagliptin as Add-On Therapy to Metformin and Glimepiride in Indian Patients with Type 2 Diabetes Mellitus: A Randomized Open-Label Trial
Noor Husain, Lalit Mohan, Sukalyan Saha Roy, Anand Kumar, Prabhat Kumar Agrawal, Shambo Samrat Samajdar, Shashank R. Joshi
A
BSTRACT
Background:
Type 2 diabetes mellitus (T2DM) is highly prevalent in India and is frequently associated with early β-cell dysfunction and progressive treatment failure. Many patients require escalation to triple oral therapy. Imeglimin is a novel oral antihyperglycemic agent that improves both insulin secretion and insulin sensitivity through modulation of mitochondrial bioenergetics. However, direct comparisons with dipeptidyl peptidase-4 inhibitors in Indian patients remain limited.
Objective:
The objective of this study was to compare the efficacy and safety of imeglimin versus vildagliptin as add-on therapy to metformin and glimepiride in Indian patients with inadequately controlled T2DM.
Methods:
This randomized, open-label, parallel-group study enrolled adults with inadequately controlled T2DM receiving stable doses of metformin and glimepiride. Participants were randomized (1:1) to receive either imeglimin 1000 mg twice daily or vildagliptin 50 mg twice daily for 48 weeks. The primary outcome was change in glycated hemoglobin (HbA1c) from baseline to week 48. Secondary outcomes included fasting plasma glucose (FPG), body weight, and safety outcomes.
Results:
A total of 100 participants were randomized equally into the imeglimin and vildagliptin groups. Baseline characteristics were comparable between groups. At week 48, mean HbA1c decreased by 0.79% (95% confidence interval [CI] −0.85 to −0.73) in the imeglimin group and by 0.72% (95% CI −0.77 to −0.67) in the vildagliptin group, with no significant between-group difference (
Conclusion:
Imeglimin demonstrated glycemic efficacy comparable to vildagliptin when used as add-on therapy to metformin and glimepiride in Indian patients with T2DM. Both therapies showed acceptable tolerability over 48 weeks, supporting imeglimin as a potential alternative third-line oral agent.