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CTRI Number  CTRI/2025/06/089609 [Registered on: 26/06/2025] Trial Registered Prospectively
Last Modified On: 17/06/2025
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   A Study on the Effect of Adding Imeglimin to Existing Treatment on HbA1c Reduction in Adults with Uncontrolled Type 2 Diabetes. 
Scientific Title of Study   Study of Outcomes with Use of Novel Drug in Diabetes: Effectiveness of Imeglimin in the Uncontrolled Diabetes in South Indian population 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR ASHWIN KARUPPAN V 
Designation  FOUNDER AND MEDICAL DIRECTOR, 
Affiliation  Tambaram Medical Center and Research Institute (TMCRI Pvt.Ltd) 
Address  D-3,Department of Internal Medicine and Diabetology , Clinical Research Division,TMCRI Pvt Ltd 30,Bharathamadha St, East Tambaram.

Kancheepuram
TAMIL NADU
600059
India 
Phone  09884551515  
Fax    
Email  drashwinkaruppan@tambarammedicalcenter.com  
 
Details of Contact Person
Scientific Query
 
Name  DR HARIHARAN SUKUMARAN 
Designation  HEAD OF THE DEPARTMENT,CLINICAL RESEARCH 
Affiliation  Tambaram Medical Center and Research Institute (TMCRI Pvt.Ltd) 
Address  D-7,Department of Internal Medicine and Diabetology , Clinical Research Division,TMCRI Pvt Ltd 30, Bharathamadha St, East Tambaram,

Kancheepuram
TAMIL NADU
600059
India 
Phone  6383346130  
Fax    
Email  crchead@tambarammedicalcenter.com  
 
Details of Contact Person
Public Query
 
Name  DR HARIHARAN SUKUMARAN 
Designation  HEAD OF THE DEPARTMENT,CLINICAL RESEARCH 
Affiliation  Tambaram Medical Center and Research Institute (TMCRI Pvt.Ltd) 
Address  D-7,Department of Internal Medicine and Diabetology , Clinical Research Division,TMCRI Pvt Ltd 30, Bharathamadha St, East Tambaram,

Kancheepuram
TAMIL NADU
600059
India 
Phone  6383346130  
Fax    
Email  crchead@tambarammedicalcenter.com  
 
Source of Monetary or Material Support  
Saan Labs LLP,No, 24A, First floor, Rajendran St, Thiru Nagar, Valasaravakkam, Chennai, Tamil Nadu 600087. 
 
Primary Sponsor  
Name  Tambaram Medical Center and Research Institute TMCRI Pvt Ltd  
Address  30,Bharathamadha Street,Tambaram,Kancheepuram, Tamilnadu-600059 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR ASHWIN KARUPPAN V  TAMBARAM MEDICAL CENTER AND RESEARCH INSTITUTE (TMCRI PVT LTD)  D-3,Department of Internal Medicine and Diabetology , Clinical Research Division,TMCRI Pvt Ltd 30, Bharathamadha St, East Tambaram, Tambaram, Kanchepuram, Tamil Nadu 600059
Kancheepuram
TAMIL NADU 
09884551515

drashwinkaruppan@tambarammedicalcenter.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INDIAN MEDICAL ASSOCIATION-TAMBARAM CHENNAI INSTITUTIONAL HUMAN ETHICS COMMITTEE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Imeglimin 500 Mg  Imeglimin 500 Mg for two times a day from Baseline to 6 months. 
Comparator Agent  Not Applicable  Not Applicable  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details 
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
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in Glycated Hemoglobin HbA1c  3 month and 6 month 
 
Secondary Outcome  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   02/07/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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.

 
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