1*(Junior Resident) Department of Pharmacology, Sarojini Naidu Medical College, Agra. Email: tinudevu123@gmail.com (Corresponding Author)
2(Associate Professor) Department of Pharmacology, Sarojini Naidu Medical College, Agra. Email: alka.dly@gmail.com
3(Professor) Department of Medicine, Sarojini Naidu Medical College, Agra. Email: prabhatagrawal321@gmail.com
4(Associate Professor) Department of Pharmacology, Sarojini Naidu Medical College, Agra. Email: dr.vipin2001@gmail.com
5(Associate Professor) Department of Pharmacology, Sarojini Naidu Medical College, Agra. Email: dranurag2008@rediffmail.com
Background: Type 2 Diabetes Mellitus (T2DM) is a chronic metabolic disorder caused by insulin resistance and impaired secretion, affecting millions globally. In India, the prevalence of diabetes is 11.4%. Management includes lifestyle changes and medications like Metformin, which is the first-line treatment. Despite available therapies, glycaemic control remains suboptimal in many patients, leading to the need for combination treatments. Imeglimin is a novel anti-hyperglycaemic agent approved in Japan (2021) and India (2022). It offers a unique mechanism of action by enhancing insulin secretion and decreasing insulin resistance. This study compares the efficacy and safety of Imeglimin versus Metformin in newly diagnosed T2DM patients.
Methods: This was an observational, analytical, open-label, cohort study. A total of 180 newly diagnosed T2DM patients were enrolled, who were not on any medications. Patients were enrolled into two groups of 90 each, depending on the treatment given by the clinician: one group received Imeglimin 500mg/1gm BD, while the other received Metformin 500mg/1gm BD for 6 months. Follow-ups were done at 1,3, and 6 months. The primary outcome was the change in FBS, PPBS, and HbA1c from baseline to 6 months (week 24).
Results: Both groups showed a clinically significant reduction in FBS, PPBS, and HbA1c levels; however, the difference between the two groups was not clinically significant. Both groups experienced a reduction in TC, TG, and LDL with no statistically significant differences between the groups. However, the Metformin group showed a significantly higher increase in HDL compared to the Imeglimin group. Abdominal fullness and constipation were the most common side effects seen in patients in the metformin group. Hypoglycemia was not observed with either Imeglimin or Metformin during the study.
Conclusion: This study suggests that Imeglimin provides glycemic control comparable to Metformin, making it a hopeful alternative for diabetes management.
Keywords: Type 2 diabetes mellitus, Imeglimin, Metformin, HbA1c, efficacy, safety
How to cite this article: Panchal S, Yadav A, Agrawal P, Kumar V, Jain A. A Comparative Evaluation of Imeglimin and Metformin Monotherapy in Newly Diagnosed Type 2 Diabetes Patients. Int J Drug Deliv Technol. 2026;16(11s): 601. DOI: 10.25258/ijddt.16.11s.60
Source of support: Nil.
Conflict of interest: None