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CTRI Number  CTRI/2024/03/064846 [Registered on: 27/03/2024] Trial Registered Prospectively
Last Modified On: 27/03/2024
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A Phase IV clinical trial to evaluate the safety and efficacy of Imeglimin 500 mg and 1000 mg tablets. 
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  IME 
Secondary IDs if Any  
Secondary ID  Identifier 
SYN/CT/016/IME/2022 Ver No. 1.1 date 27 Feb 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mukesh Kumar  
Designation  Director-Clinical Operations 
Affiliation  RAHE Life Science 
Address  Plot 32 UG4 Utkarsh tower Vijay Block Laxmi Nagar New Delhi East DELHI 110032 India

East
DELHI
110092
India 
Phone  9873038019  
Fax    
Email  mukesh@rahelife.com  
 
Details of Contact Person
Scientific Query  
Name  Mukesh Kumar  
Designation  Director-Clinical Operation 
Affiliation  RAHE Life Science 
Address  Plot 32 UG4 Utkarsh tower Vijay Block Laxmi Nagar New Delhi East DELHI 110032 India

East
DELHI
110092
India 
Phone  9873038019  
Fax    
Email  mukesh@rahelife.com  
 
Details of Contact Person
Public Query  
Name  Mukesh Kumar  
Designation  Director-Clinical Operation 
Affiliation  RAHE Life Science 
Address  Plot 32 UG4 Utkarsh tower Vijay Block Laxmi Nagar New Delhi East DELHI 110032 India

East
DELHI
110092
India 
Phone  9873038019  
Fax    
Email  mukesh@rahelife.com  
 
Source of Monetary or Material Support  
Synokem Pharmaceuticals Limited 
 
Primary Sponsor  
Name  Synokem Pharmaceuticals Limited 
Address  14/486, Sunder Vihar Outer Ring Rd, Block 12, Paschim Vihar, New Delhi- 110087, India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Nil   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sagorika Mullick  Abhayahasta Multispeciality Hospital  Kaggadasapura Main Road CV Raman Nagar Bengaluru
Bangalore
KARNATAKA 		 9591646261

cr@abhayahastahospital.com 
Dr Anil Samaria  Jawahar Lal Nehru Medical College  Kala Bagh Ajmer
Ajmer
RAJASTHAN 		 01452431842

anilsamria14@gmail.com 
Dr Pradeep Jain  Poddar Hospital  Gangori Bazar Jaipur
Jaipur
RAJASTHAN 		 9782075213

poddardiagnostic@gmail.com 
Dr Sunil Kumar Aren  Raj Bahadur Memorial Hospital   Attached to Shri Jagannath Pahadiya medical college Vikas Nagar Bharatpur
Bharatpur
RAJASTHAN 		 8955653703

drsunilaren57@gmail.com 
Dr Ashok Kumar  Santosh Medical college Hospital  1 Ambedkar Rd Opposite Old Bus Stand Maliwara Nehru Nagar Ghaziabad
Ghaziabad
UTTAR PRADESH 		 999038457

dr_ashk2006@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
IEC, Abhayahasta Superspeciality Hospital  Approved 
Institutional Ethics Committe Jawahar Lal Nehru Medical Collegee  Submittted/Under Review 
P R Poddar Institutional Ethics Committee Poddar Hospital  Approved 
Shri Jagannath Pahadiya Medical College IEC  Submittted/Under Review 
Society for Research Welfare  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 1000 mg  Imeglimin 1000 mg Tablets once a day orally for 112 days 
Intervention  Imeglimin 500 mg   Imeglimin 500 mg Tablets twice a day orally for 112 days 
 
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/IRB approved Informed Consent Form (ICF) prior to initiation of any study procedures.
2.Male and Female subjects of group age ≥18 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 ≥7.5 to ≤ 8.5 %.
4.Type 2 diabetes (fasting glucose ≥126 mg/dl).
5.Women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study. WOCBP must have a negative urine pregnancy test at screening/ base line.
 
 
ExclusionCriteria 
Details  1. Subjects who are not able to or not willing to sign an IRB/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/lactating mothers.
4. Fasting plasma glucose > 200 mg/dl (>15 mmol/L).
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   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Mean Change in HbA1c   from base line to Day 84 week 12. 
 
Secondary Outcome  
Outcome  TimePoints 
Mean Change in fasting plasma glucose from baseline to EOT (Day 112, week16).
 		 from base line to EOT Day 112 week 16 
Mean Change in 2-hr post prandial plasma glucose (2-hr PPG)
 		 from baseline
to EOT (Day 112, week16). 
Proportion of patients achieving a therapeutic glycemic response, defined as
HBA1C 7%  		 at the EOT (Day 112, week16). 
 
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   N/A 
Date of First Enrollment (India)   10/04/2024 
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   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.

Primary Objective

To evaluate the safety 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.

Secondary Objective

To evaluate the 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.

 
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