Type 2 diabetes mellitus (T2DM) accounts for approximately 90% of diabetes cases worldwide, and imeglimin is a novel oral antidiabetic agent with a unique mechanism of action targeting glucose homeostasis, insulin secretion, and oxidative stress. This Phase IV, randomized, open-label, prospective, non-comparative, multicentre study evaluated the efficacy, safety, and tolerability of imeglimin hydrochloride 500 mg and 1000 mg as monotherapy in treatment-naïve adults with T2DM inadequately controlled by diet and exercise. The study was conducted across multiple centres in India between June 2023 and January 2024 over 16 weeks and was registered with the Clinical Trials Registry–India (CTRI/2023/06/053621). Participants aged 18–65 years with HbA1c >7.0% to ≤8.5% despite at least three months of diet and exercise therapy were randomized to receive imeglimin 500 mg or 1000 mg. Changes in HbA1c, fasting plasma glucose (FPG), 2-hour postprandial glucose (PPG), and adverse events were assessed. In the 500 mg group, 210 participants were randomized and 204 completed the study, while in the 1000 mg group, 210 were randomized and 206 completed the study. At week 16, mean HbA1c decreased by 0.82% and 0.72% in the 500 mg and 1000 mg groups, respectively. Mean FPG decreased by 18.86 mg/dL and 16.45 mg/dL at week 16 in the 500 mg and 1000 mg groups, respectively, with improvements also observed in 2-hour PPG. Adverse events occurred in 18.57% of participants receiving 500 mg and 13.33% receiving 1000 mg, with abdominal pain, dyspepsia, nausea, headache, and vomiting among the commonly reported events. No serious adverse events were reported. Imeglimin monotherapy at both 500 mg and 1000 mg demonstrated improvements in glycemic parameters and was generally well tolerated in adults with T2DM inadequately controlled with diet and exercise, suggesting its potential as a therapeutic option for glycemic management in this patient population.

Prashant Kumthekar is a clinical research professional with more than 14 years of experience in the pharmaceutical and clinical research sector. He completed his Master’s degree in Pharmacology from Dr. M.G.R. Medical University, Chennai, India. He currently heads the Clinical Research Department at Exemed Pharmaceuticals, where he is involved in clinical research and pharmacovigilance activities. His professional experience includes clinical trial management, site selection and vendor qualification, Phase III and Phase IV clinical trials, bioavailability and bioequivalence studies, and assessment of medicinal product safety profiles. He has contributed to clinical research publications and presentations, particularly in the areas of diabetes and other therapeutic indications. His work reflects a strong commitment to clinical research, pharmacovigilance, regulatory compliance, and evidence-based healthcare. He has also been involved in research on imeglimin and other pharmaceutical therapies, contributing to the generation of clinical evidence supporting their efficacy and safety.