| CTRI Number |
CTRI/2025/02/079966 [Registered on: 06/02/2025] Trial Registered Prospectively |
| Last Modified On: |
06/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Interventional, Single arm, open-label study to evaluate the efficacy and safety of Imeglimin using Continuous Glucose Monitoring (CGM) in Type 2 Diabetes Mellitus (T2DM) patients |
|
Scientific Title of Study
|
A prospective, investigator initiated, interventional, single arm, open-label study to evaluate
the efficacy and safety of Imeglimin using Continuous Glucose Monitoring (CGM) in Type 2
Diabetes Mellitus (T2DM) patients |
| 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 Unnikrishnan Ambika Gopalakrishnan |
| Designation |
DM(Endocrinology), MD (General Medicine) |
| Affiliation |
Chellaram Diabetes Institute |
| Address |
Chellaram Diabetes Institute, I Floor, Lalani Quantum, Pune- Bangalore NH4, Bavdhan (BudrukI)
Pune
MAHARASHTRA
411021
India |
| Phone |
9689287337 |
| Fax |
|
| Email |
uagcdi@cdi.org.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Unnikrishnan Ambika Gopalakrishnan |
| Designation |
DM(Endocrinology), MD (General Medicine) |
| Affiliation |
Chellaram Diabetes Institute |
| Address |
Chellaram Diabetes Institute, I Floor, Lalani Quantum, Pune- Bangalore NH4, Bavdhan (BudrukI)
Pune
MAHARASHTRA
411021
India |
| Phone |
9689287337 |
| Fax |
|
| Email |
uagcdi@cdi.org.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Unnikrishnan Ambika Gopalakrishnan |
| Designation |
DM(Endocrinology), MD (General Medicine) |
| Affiliation |
Chellaram Diabetes Institute |
| Address |
Chellaram Diabetes Institute, I Floor, Lalani Quantum, Pune- Bangalore NH4, Bavdhan (BudrukI)
Pune
MAHARASHTRA
411021
India |
| Phone |
9689287337 |
| Fax |
|
| Email |
uagcdi@cdi.org.in |
|
|
Source of Monetary or Material Support
|
| Chellaram Diabetes Institute,
I Floor, Lalani Quantum, Pune- Bangalore NH4, Bavdhan (BudrukI) Pune, Maharashtra, INDIA -411021 |
|
|
Primary Sponsor
|
| Name |
Dr Unnikrishnan Ambika Gopalakrishnan |
| Address |
Chellaram Diabetes Institute, I Floor, Lalani Quantum, Pune- Bangalore NH4, Bavdhan (BudrukI) Pune, Maharashtra, INDIA -411021 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Unnikrishnan Ambika Gopalakrishnan |
Chellaram Diabetes Institute |
Department of Diabetology
1st Floor, Lalani Quantum, Pune- Bangalore NH4, Bavdhan (BudrukI) Pune, Maharashtra, INDIA -411021
Pune
MAHARASHTRA |
9689287337
uagcdi@cdi.org.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chellam Diabetes Institute Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Diabetes |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Imeglimin |
Imeglimin in patients with T2DM. Using CGM technology.
Dose-1000mg twice a day for 12 weeks |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged 18-75 years
2. Patients diagnosed with T2DM for more than 180 days
3. Patients with T2DM, who had poor control of blood glucose levels (HbA1c 7-10.5%) in spite of diet and exercise therapy for 1 month or longer, with or without Oral Anti Diabetic Treatment (up to maximum of 3 OADs)
4. Patients / Legally Acceptable Representative who are willing to provide written informed consent.
5. Patients who are willing and able to comply with study procedures and follow-up assessments |
|
| ExclusionCriteria |
| Details |
1.Patients Diagnosed with type 1 diabetes mellitus, maturityonset diabetes of the young, latent autoimmune diabetes in adults, gestational diabetes or any hyperglycemic state other than T2DM.
2. Female patients who are pregnant, breastfeeding, or planning to become pregnant during the conduct of the study
3. Patients with history or presence of clinically significant disease which as per the investigator might interfere with patient’s participation in the study or would jeopardize the outcome of the trial
4. Patients with any contraindications for Imeglimin, including hypersensitivity to the active substances or any of the excipients
5. Patients with Moderate or severe renal dysfunction (Estimated Glomerular Filtration Rate (eGFR)less than 45 mL/min/1.73 m2)
6. Patients with severe hepatic dysfunction
7. Patients undergoing insulin treatment
8. Patients currently participating in another clinical/investigational study
9. Patients who participated in another interventional T2DM clinical study within 3 months prior enrolment into the current study
10. Patients who, in the opinion of the investigator, are unlikely to comply with the study protocol or follow-up requirements
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Glycemic Profile Assessment, based on pre- & post administration changes in the following parameters: [Time Frame: From Enrolment to EOS (Week 12)]
- Mean amplitude of glycemic excursions (MAGE)
- Time in Range (TIR)
- Time above Range (TAR)
- Time below Range (TBR)
- Glycemic Variability (GV) using the coefficient of variation of blood glucose |
14 to 16 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Efficacy will be determined based on the following parameters:
-Change in Homeostasis Model Assessment of Beta-cell Function (Homa-β) & Homeostasis Model Assessment of Insulin Resistance (Homa-IR)
[Time Frame: Enrolment and EOS (Week 12)]
- Mean change in Hemoglobin A1c (HbA1c)
[Time Frame:Enrolment and EOS (Week 12)]
- Mean change in Fasting Blood Glucose (FBG) levels
[Time Frame: Enrolment and EOS (Week 12)]
- Mean change in Post Prandial Blood Glucose (PPG) levels
[Time Frame: Enrolment and EOS (Week 12)]
- Mean change in Fasting & Post Prandial C- Peptide levels
[Time Frame: Enrolment and EOS (Week 12)]
• Safety will be assessed based on number of Adverse Eventsn(AEs) and Serious Adverse Events (SAEs) reported
[Time Frame: From Enrolment to EOS (12 weeks)
|
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
17/02/2025 |
| 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="6"
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
|
Type 2 diabetes mellitus (T2DM), the most common type of diabetes, is a chronic condition that occurs due to persistently high blood sugar (glucose) levels (hyperglycemia). Blood glucose obtained from food is the main source of energy and Insulin, (a hormone made by the beta cells of pancreas) helps glucose get into the fat, liver and muscle cells to be used for energy.Imeglimin is a first-in-class novel oral antidiabetic drug used to treat T2DM targeting mitochondrial bioenergetics. It improves mitochondrial function by modulating mitochondrial respiratory chain complex activities while decreasing reactive oxygen species production. Imeglimin has been shown to amplify glucose-stimulated insulin secretion by improving β-cell glucose response in patients with T2DM and to improve insulin sensitivity in a rodent model of diabetes, allowing for normalization of glucose tolerance. More recent data suggest that imeglimin prevents the death of human endothelial cells by inhibiting opening of the mitochondrial permeability transition pore—a known cause of cell death—without inhibiting mitochondrial respiration this finding suggests the potential for end organ protection (e.g. kidney or heart)
The current study is an open-label, single-arm interventional trial initiated by the investigator to evaluate the efficacy and safety of Imeglyn® in patients with T2DM. Using CGM technology, the study will capture real-time data on glucose dynamics, such as postprandial spikes and hypoglycemic episodes. This approach aims to provide a deeper understanding of Imeglimin’s clinical benefits, offering insights beyond conventional glycemic measurements. |