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
|
|
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
|
|
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.
|