| CTRI Number |
CTRI/2025/08/092573 [Registered on: 07/08/2025] Trial Registered Prospectively |
| Last Modified On: |
07/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study Comparing the Effect and Safety of Imeglimin and Glimepiride in People with Type 2 Diabetes in a Tribal Area of Gujarat |
|
Scientific Title of Study
|
A comparative evaluation of Imeglimin versus Glimepiride in patients with type 2 Diabetes Mellitus in a tribal population of Gujarat |
| 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 Yash Rajubhai Pathak |
| Designation |
Post Graduate Resident |
| Affiliation |
Zydus Medical College and Hospital |
| Address |
Department of Pharmacology, Zydus Medical College and Hospital, Nimnaliya, Muvaliya, Dahod
Dohad
GUJARAT
389151
India |
| Phone |
6358279598 |
| Fax |
|
| Email |
yashpathak5656@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suraj Tripathi |
| Designation |
Professor and Head of Department |
| Affiliation |
Zydus Medical College and Hospital |
| Address |
Department of Pharmacology, Zydus Medical College and Hospital, Nimnaliya, Muvaliya, Dahod
Dohad
GUJARAT
389151
India |
| Phone |
9926396896 |
| Fax |
|
| Email |
surajpharmacol@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suraj Tripathi |
| Designation |
Professor and Head of Department |
| Affiliation |
Zydus Medical College and Hospital |
| Address |
Department of Pharmacology, Zydus Medical College and Hospital, Nimnaliya, Muvaliya, Dahod
GUJARAT
389151
India |
| Phone |
9926396896 |
| Fax |
|
| Email |
surajpharmacol@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self Funded.Zydus Medical College and Hospital Civil Hospital, Opp.Naheru Baug, Behind Bhagini Samaj, Station Road, Dahod-389151,Gujarat-India. |
|
|
Primary Sponsor
|
| Name |
Dr Yash Pathak |
| Address |
Department of Pharmacology, Zydus Medical College and Hospital, Nimnaliya-Muvaliya, Dahod |
| Type of Sponsor |
Other [Self funded] |
|
|
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 |
| Yash Pathak |
Zydus Medical Hospital |
Room No.2,Ground Floor,Department Of Medicine,NCD Clinic.
Ahmadabad
GUJARAT |
6358279598
yashpathak5656@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E11||Type 2 diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Glimepiride |
Glimepiride 2 mg oral tablet, administered once daily, as add-on to Metformin, for a duration of 3 months |
| Intervention |
Imeglimin |
Imeglimin 500 mg oral tablet, administered twice daily, as add-on to Metformin, for a duration of 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Informed consent from participants as documented by signature
2. Type 2 Diabetes Mellitus
4. HbA1c 7 to 10%
5. Patient already on metformin with uncontrolled Type 2 diabetes
|
|
| ExclusionCriteria |
| Details |
1. Type 1 Diabetes Patients
2. Hypersensitivity to Imeglimin, Sulfonylureas & Metformin
3. Chronic Kidney Diseases (eGFR less than 45ml/min)
4. Liver dysfunction (AST/ALT more than 3× upper limit).
5. Pregnant and lactating women
6. Corticosteroids within 3 months before enrollment or during period of study
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients achieving HbA1c less than 7% |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| possible secondary outcome - Reduced Incidence of hypoglycemic episodes. |
|
|
|
Target Sample Size
|
Total Sample Size="170"
Sample Size from India="170"
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
|
N/A |
|
Date of First Enrollment (India)
|
21/08/2025 |
| 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) |
Not Yet Recruiting |
|
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 an academic, hospital-based, interventional, prospective cohort study designed to compare the efficacy and safety of Imeglimin versus Glimepiride as add-on therapy to Metformin in patients with Type 2 Diabetes Mellitus (T2DM) belonging to a tribal population of Gujarat. The trial is being conducted at Zydus Medical College and Hospital, Dahod, as part of a postgraduate academic research project.
A total of 170 participants with uncontrolled T2DM on Metformin (HbA1c 7–10%) will be enrolled and randomized into two groups:
Participants will be followed for 3 months with monthly assessments of glycemic parameters (HbA1c, FBS, PPBS) along with body weight, blood pressure, and safety outcomes (including adverse events). Ophthalmic evaluation and relevant laboratory investigations (lipid profile, RFT, LFT, electrolytes, CBC) will also be performed.
The primary objective is to compare glycemic efficacy (HbA1c, FBS, PPBS).
The secondary objectives include evaluating safety, changes in body weight, and blood pressure.
The study adheres to ethical standards, with Institutional Ethics Committee approval and written informed consent from all participants. Data will be analyzed using appropriate statistical tests (independent t-test). Being a single-center, self-funded academic trial, the results aim to provide evidence on whether Imeglimin offers superior efficacy and safety compared to Glimepiride in this specific population. |