Effectiveness and safety of imeglimin in routine clinical practice among Indian patients with type 2 diabetes mellitus: a prospective, non-interventional, real-world observational study (INDI-TIMES 2.0)
12 affiliations
- 1School Of Medicine and Public Health, The Newcastle University, Newcastle, NSW, Australia
- 2Narayana Health Rabindranath Tagore International Institute Of Cardiac Sciences, Eastern Metropolitan Bypass, Mukundapur Market, Stadium Colony, Mukundapur, Kolkata, West Bengal, India
- 3Kali Prasad Chowdhury Medical College and Hospital, Jadavpur, Kolkata, West Bengal, India
- 4Department of Medicine, Hind Institute of Medical Sciences, Sitapur, India
- 5Binapani Doctors Clinic, Khelar Mat, University, West Bengal, Kolkata, India
- 6Lina Diabetes Care Mumbai Diabetes Research Center, Cosmos Plaza, Opp. Indian Oil Nagar, Andheri West, Mumbai, India
- 7Dept. of Medicine, Shilpa Medical Research Center, Awadhoot Nagar, Dahisar East, Mumbai, Maharashtra, India
- 8ReLiv Healthy India Pvt.Ltd., MLA Colony, Banjara Hills, Hyderabad, Telangana, India
- 9Zyva Life, Ambedkar Colony, Film Nagar, Hyderabad, Telangana, India
- 10Miot Hospital, Chennai, Sivasami Salai, Mylapore, Chennai, India
- 11Chokkikulam, Tamil Nadu, Madurai, India
- 12Zydus Healthcare Limited, Zydus Tower, Goregaon (E), Mumbai, India
Abstract
Introduction: Imeglimin is the first agent of the ‘glimin’ class of glucose-lowering medication. Clinical trials have demonstrated that imeglimin is effective and well-tolerated in patients with Type 2 Diabetes Mellitus (T2DM). This prospective, non-interventional, single-arm, open-label, multi-center observational study evaluates the effectiveness and safety of imeglimin in routine clinical practice in India.
Methods: The study was conducted across 145 centers in India. Adults (≥18 years) with T2DM who were prescribed imeglimin 1000 mg twice daily, either as monotherapy or as add-on therapy, were enrolled and followed for 16 weeks. The primary endpoint was the change in glycated hemoglobin (HbA1c) from baseline to Week 16. Secondary endpoints included changes in fasting blood glucose (FBG), postprandial blood glucose (PPBG), and safety outcomes.
Results: Of 2,705 screened, 2,704 participants with T2DM were included in the analysis. Mean HbA1c decreased significantly from 8.78% (SD 1.16) at baseline to 7.38% (SD 0.98) at Week 16, with a mean reduction of −1.40% (SD 0.99; p < 0.0001). Significant reductions were also observed in FBG (−46.1 mg/dL) and PPBG (−72.0 mg/dL) from baseline to Week 16 (both p < 0.0001). Improvements in HbA1c levels were consistent across age and gender subgroups. No adverse events (AEs) were reported among participants with the available safety data.
Conclusion: These findings demonstrate that imeglimin 1000 mg twice daily was associated with clinically meaningful improvements in glycemic control over 16 weeks and was generally well tolerated, supporting its effectiveness and safety for the management of T2DM in real-world settings.
Related
- A Poly‐L‐Lactic Acid Formulation for Nasolabial Fold Correction: Handling, Tolerability and Effectiveness in a Prospective Observational Study
- Effectiveness and Patient Satisfaction With Zastaprazan in Real-World Practice: A Large-Scale Prospective Observational Study
- Real-world effectiveness and safety of enavogliflozin in patients with type 2 diabetes: A 24-week prospective multicenter observational study in Korea.
- Effectiveness of metformin as initial treatment on the metabolic profile of Saudi patients newly diagnosed with type 2 diabetes mellitus : A prospective observational study
- Safety and Preliminary Clinical Outcomes of Integrating Engineered Synthetic Lipid Vesicles (Biosomes) in a Skin Booster Protocol: A Prospective Observational Study
BibTeX
@article{sanyal2026effectiveness,
title = {{Effectiveness and safety of imeglimin in routine clinical practice among Indian patients with type 2 diabetes mellitus: a prospective, non-interventional, real-world observational study (INDI-TIMES 2.0)}},
author = {Debmalya Sanyal and Anuj Maheshwari and Subrata Chakrabarti and Manoj Chawla and Mangesh Tiwaskar and Soujanya Kunapa Reddy and S Sridhar and Arthur Joseph Ashirvatham and Rituraj Benode Deb and Gayathry V M},
journal = {Frontiers in Endocrinology},
year = {2026},
month = oct,
doi = {10.3389/fendo.2026.1973270},
url = {https://doi.org/10.3389/fendo.2026.1973270},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Effectiveness and safety of imeglimin in routine clinical practice among Indian patients with type 2 diabetes mellitus: a prospective, non-interventional, real-world observational study (INDI-TIMES 2.0)
AU - Debmalya Sanyal
AU - Anuj Maheshwari
AU - Subrata Chakrabarti
AU - Manoj Chawla
AU - Mangesh Tiwaskar
AU - Soujanya Kunapa Reddy
AU - S Sridhar
AU - Arthur Joseph Ashirvatham
AU - Rituraj Benode Deb
AU - Gayathry V M
PY - 2026
DA - 2026/10/12
JO - Frontiers in Endocrinology
DO - 10.3389/fendo.2026.1973270
UR - https://doi.org/10.3389/fendo.2026.1973270
AB - Introduction: Imeglimin is the first agent of the ‘glimin’ class of glucose-lowering medication. Clinical trials have demonstrated that imeglimin is effective and well-tolerated in patients with Type 2 Diabetes Mellitus (T2DM). This prospective, non-interventional, single-arm, open-label, multi-center observational study evaluates the effectiveness and safety of imeglimin in routine clinical practice in India. Methods: The study was conducted across 145 centers in India. Adults (≥18 years) with T2DM who were prescribed imeglimin 1000 mg twice daily, either as monotherapy or as add-on therapy, were enrolled and followed for 16 weeks. The primary endpoint was the change in glycated hemoglobin (HbA1c) from baseline to Week 16. Secondary endpoints included changes in fasting blood glucose (FBG), postprandial blood glucose (PPBG), and safety outcomes. Results: Of 2,705 screened, 2,704 participants with T2DM were included in the analysis. Mean HbA1c decreased significantly from 8.78% (SD 1.16) at baseline to 7.38% (SD 0.98) at Week 16, with a mean reduction of −1.40% (SD 0.99; p < 0.0001). Significant reductions were also observed in FBG (−46.1 mg/dL) and PPBG (−72.0 mg/dL) from baseline to Week 16 (both p < 0.0001). Improvements in HbA1c levels were consistent across age and gender subgroups. No adverse events (AEs) were reported among participants with the available safety data. Conclusion: These findings demonstrate that imeglimin 1000 mg twice daily was associated with clinically meaningful improvements in glycemic control over 16 weeks and was generally well tolerated, supporting its effectiveness and safety for the management of T2DM in real-world settings.
SN - 1664-2392
ER -