A Study on the Effect of Adding Imeglimin to Existing Treatment on HbA1c Reduction in Adults with Uncontrolled Type 2 Diabetes.

Not Applicable

Not yet recruiting

• Conditions: Type 2 diabetes mellitus without complications,

• Registration Number: CTRI/2025/06/089609
• Lead Sponsor: Tambaram Medical Center and Research Institute TMCRI Pvt Ltd

Brief Summary

This is a single arm, prospective, real-world interventional study evaluating the efficacy and safety of Imeglimin 500 mg twice daily as an add-on therapy in South Indian patients with uncontrolled type 2 diabetes mellitus (T2DM), despite being on a stable oral antidiabetic regimen. Participants with HbA1c greater than 7.5% will be enrolled. Mitochondrial dysfunction is a key contributor to both impaired insulin secretion and insulin resistance in T2DM. Imeglimin acts by improving mitochondrial bioenergetics, enhancing ATP production in pancreatic beta cells to restore glucose stimulated insulin secretion. Additionally, it improves insulin sensitivity in peripheral tissues, thereby addressing both core defects of T2DM. With a favorable safety and tolerability profile and limited data in South Indian populations, this study aims to generate real-world evidence on its effectiveness and safety. The primary endpoint is change in HbA1c at 3 and 6 months. Secondary endpoints include changes in fasting and postprandial glucose levels, weight, BMI, lipid profile, tolerability, and adverse drug reactions (assessed using the Naranjo scale). The study will be conducted at a tertiary care hospital in South India, with drug and laboratory support provided by Sans Labs LLP.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-02-07
• Last Update Posted: 2025-06-17

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Diagnosed Type 2 Diabetes Mellitus for more than 1 year HbA1c greater than 7.5 percentage despite stable antidiabetic therapy for 3 months and more Willing to provide written informed consent.

Exclusion Criteria

Type 1 diabetes or other specific types of diabetes Chronic Kidney Disease Patient or hepatic dysfunction Recent cardiovascular event within 6 months Pregnant or lactating women Known hypersensitivity to Imeglimin.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Glycated Hemoglobin HbA1c	3 month and 6 month

Secondary Outcome Measures

Name	Time	Method
Change in Body Weight and Body Mass Index (BMI)	1 month, 3 month and 6 month
Change in Lipid Profile (Total Cholesterol, LDL, HDL, Triglycerides)	3 month and 6 month
Incidence, type, and causality of Adverse Drug Reactions (ADRs)	Monitored Everyday via tele calling.
Change in Fasting Plasma Glucose (FPG) and Postprandial Blood Sugar (PPBS)	Month 1,Month 3 and 6 month

Trial Locations

Locations (1)

TAMBARAM MEDICAL CENTER AND RESEARCH INSTITUTE (TMCRI PVT LTD); 🇮🇳 Kancheepuram, TAMIL NADU, India

TAMBARAM MEDICAL CENTER AND RESEARCH INSTITUTE (TMCRI PVT LTD)

🇮🇳Kancheepuram, TAMIL NADU, India

DR ASHWIN KARUPPAN V

Principal investigator

09884551515

drashwinkaruppan@tambarammedicalcenter.com