CTRI/2026/03/107198 [Registered on: 30/03/2026] Trial Registered Prospectively
Last Modified On:
23/03/2026
Post Graduate Thesis
No
Type of Trial
PMS
Type of Study
Drug
Study Design
Randomized, Parallel Group Trial
Public Title of Study
A clinical study to evaluate the safety and efficacy of Imeglimin Tablets in diabetes patients.
Scientific Title of Study
A Multi-centric, Open label, Randomized, Non-Comparative, Two-Arm, Phase IV clinical trial to evaluate the safety and efficacy of Imeglimin 500 mg and 1000 mg tablets in the treatment of patients diagnosed with type-II diabetes mellitus in adequate control of diet and exercise alone.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
SYN/CT/016/IME/2022, Version No.:1.1 and Dated Feb 27, 2023
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Institutional Ethics Committee, R. G. Kar Medical College and Hospital
Submittted/Under Review
Institutional Ethics Committee, S N Medical College
Submittted/Under Review
Moraya Institutional Ethics Commmittee, Ashwin Medical Foundations Moraya Multispeciality Hospital
Submittted/Under Review
Sanjivani Lung Centre Ethics Committee (Sanjivini Hospital and Research Center)
Submittted/Under Review
Shalinitai Meghe Hospital and Research Center (SMHRC) Ethics Committee (Datta Meghe Medical College and Shalinitai Meghe Hospital and Research Centre)
Submittted/Under Review
Shree Institutional Ethics Committee, Dhadiwal Hospital In Coalition with Shreeji Health Care (Swastik Dhadiwal Hospital)
Approved
Supe Hospital Ethics Committee, Supe Heart and Diabetes Hospital and Research Centre
Submittted/Under Review
Vidhya Hospitals & Trauma Centre Ethics Committee
Submittted/Under Review
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
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 Tablets 1000 mg
Patients will be advised to take one tablet twice a day orally, swallowed with water in the morning and evening around same time every day for 112 days.
Intervention
Imeglimin Tablets 500 mg
Patients will be advised to take two tablets in the morning and two tablets in the evening orally, swallowed with water around same time every day for 112 days.
Comparator Agent
Not Applicable.
Not Applicable.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1. Subject who agrees for giving informed consent and provide signed and dated written IEC or IRB approved Informed Consent Form prior to initiation of any study procedures.
2. Male and Female subjects of group age Greater than or equal to 18 to Less than or equal to 65 years.
3. Treatment naïve patients with inadequately controlled with diet and exercise therapy alone for the at least 3 months prior to screening and having inadequate glycemic control at screening defined as HbA1c levels of Greater than or equal to 7.5 to Less than or equal to 8.5 Percentage.
4. Type 2 diabetes of fasting glucose Greater than or equal to 126 mg per dL.
5. Women of childbearing potential must be using an acceptable method of contraception to avoid pregnancy throughout the study. WOCBP must have a negative urine pregnancy test at screening or base line.
ExclusionCriteria
Details
1. Subjects who are not able to or not willing to sign an IRB or IEC approved consent form.
2. Subject with positive pregnancy test as confirmed by urine dipstick test.
3. Subject who is planning to become pregnant within the study duration or lactating mothers.
4. Fasting plasma glucose Greater than 200 mg per dL.
5. Type 1 diabetes and Evidence of serious diabetic complications
6. Evidence of serious cardiovascular complications.
7. Laboratory value abnormalities as defined by the protocol.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Mean Change in HbA1c from base line to day 84, Week 12.
Baseline and Week 12 (Day 84).
Secondary Outcome
Outcome
TimePoints
Mean change in fast plasma glucose from baseline to EOT
Proportion of patients achieving a Therapeutics glycemic response defined as HbA1C 7 percent at the day 84, Week 12.
Week 12 (Day 84).
Safety assessments such as Serum Lipid Profile (Triglycerides, HDL and LDL), LFT and RFT (BUN, Serum Creatinine and eGFR) from base line and EOT (Day 112, Week 16).
Baseline and Week 16 (Day 112).
The number of adverse events will be documented to evaluate the safety profile of study drugs from baseline to EOT (Day 112, Week 16).
Throughout the Study.
Target Sample Size
Total Sample Size="490" Sample Size from India="490" 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)
13/04/2026
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)
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 a multi-centric, open label, randomized, non-comparative, two-arm, phase IV clinical trial to evaluate the safety and efficacy of Imeglimin 500 mg and 1000 mg tablets in the treatment of patients diagnosed with type-II diabetes mellitus in adequate control of diet and exercise alone.
The efficacy of Imeglimin 500 mg and 1000 mg tablet is tested and proven in the treatment improve glycemic control in patients with type-II diabetes mellitus as per available clinical data. Therefore, we are conducting this phase IV clinical trial to determine the safety and efficacy of Imeglimin 500 mg 1000 mg tablet in Indian subjects. Eligible patients will be randomized to either Arm 1- Imeglimin 500 mg (two tablets in the morning & two tablets in the evening) or Arm 2- Imeglimin 1000 mg tablet (one tablet in the morning & one tablet in the evening). It would be a multi-centric clinical trial. We will adopt the consecutive enrollment, wherein each patient will be screened and enrolled into the study if found eligible.