A Multicenter, Retrospective Study to Evaluate the Effectiveness and Safety of Imeglimin in Patients with Type 2 Diabetes Mellitus in a Real-World Clinical Setting (INDI-TIMES Study).

INTRODUCTION

Imeglimin is a novel oral antidiabetic drug that was approved for use in India in October 2022. Thus far, no large-scale studies on the effectiveness and safety of imeglimin for the treatment of type-2 diabetes mellitus (T2DM) have been conducted in the Indian population. The objective of this study was to evaluate the effectiveness and safety of imeglimin in Indian patients with T2DM in a real-world setting.

METHODS

This observational, retrospective, real-world study was conducted at 191 sites across India from May to June 2024. Adult patients with uncontrolled T2DM (7% ≤ glycated hemoglobin (HbA1c) ≤ 9%) who were prescribed imeglimin 1000 mg twice a day as part of routine clinical practice, who were either treatment naïve or on other antidiabetic agents, and for whom a valid prescription and required data were available were included in the study. The data were collected from the medical records of eligible subjects and analyzed for the changes in glycemic indices from baseline to the 3-month follow-up.

RESULT

The data for 8301 patients (male: 59.39%) were analyzed. Of these, 2009 (24.20%) subjects received imeglimin monotherapy and 5004 (60.28%) received dual therapy. The analysis showed a statistically significant (p < 0.0001) reduction from baseline to the 3-month follow-up in glycemic indices and weight. The mean HbA1c, fasting and postprandial plasma glucose, and weight were decreased by 1.12%, 29.41 mg/dL, 62.41 mg/dL, and 2.01 kg, respectively. A total of 3547 (45.35%) subjects achieved HbA1c < 7%. No adverse events were reported.

CONCLUSION

Imeglimin shows promise as an effective and well-tolerated option for managing T2DM in the Indian population. Also, secondary impacts of imeglimin, such as improvements in the lipid profile, hepatic function, blood pressure, and weight loss, warrant further clinical exploration.