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CTRI Number  CTRI/2025/03/082295 [Registered on: 13/03/2025] Trial Registered Prospectively
Last Modified On: 11/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   A Study on the use of imeglimin 
Scientific Title of Study   Prospective Cohort Study on Imeglimin: Safety, Efficacy, and Acceptability in Type 2 Diabetes Management 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Lakshana K 
Designation  M Pharm- Pharmacy Practice  
Affiliation  Sri Ramachandra Institute of Higher Education & Research  
Address  Department of Pharmacy Practice Faculty of Pharmacy Sri Ramachandra Institute of Higher Education and Research Porur, Chennai

Chennai
TAMIL NADU
600116
India 
Phone  6369003959  
Fax    
Email  lakshana1717@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR A MOHATHASIM BILLAH 
Designation  Professor 
Affiliation  SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH. 
Address  DEPARTMENT OF PHARMACY PRACTICE, FACULTY OF PHARMACY,SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESERACH, PORUR, CHENNAI.

Chennai
TAMIL NADU
600116
India 
Phone  9488588735  
Fax    
Email  amb@sriramachandra.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr. Adlyne Reena Solomon 
Designation  Professor 
Affiliation  Sri Ramachandra Institute of Higher Education & Research  
Address  Department of Endocrinology Sri Ramachandra Institute of Higher Education and Research Porur, Chennai

Chennai
TAMIL NADU
600116
India 
Phone  9843051977  
Fax    
Email  adlynereena@yahoo.co.in  
 
Source of Monetary or Material Support  
Sri Ramachandra Institution of Higher Education and Research, Porur, Chennai 600116. 
 
Primary Sponsor  
Name  Sri ramachandra Institute of higher education and research 
Address  Sri Ramachandra Institution of Higher Education and Research, Porur, Chennai 600116. 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr AMohathasim Billah  Sri ramachandra Hospital  Sri Ramachandra Hospital Department of Endocrinology First Floor, Outpatient-A1
Chennai
TAMIL NADU 		 9488588735

amb@sriramachandra.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICS COMMITEE FOR STUDENT PROJECTS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Patients who are 18 years of age and older.
2. Patients only with type 2 diabetes mellitus .
3. Patients who are receiving Imeglimin.
4. Patients receiving Imeglimin for atleast 3 months.

 
 
ExclusionCriteria 
Details  1. Patient who are intolerant to imeglimin.
2. Patient who have stopped taking imeglimin .
3. Patient unwilling to give written informed consent.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The Study Safety, Efficacy and Patient Acceptability outcomes will focus on identifying adverse drug reactions (ADRs) associated with imeglimin, including their frequency and severity.  1 Month  
 
Secondary Outcome  
Outcome  TimePoints 
The study will likely support oral Imeglimin as an effective and safe treatment option, contributing to better management of diabetes for the population.

 		 1 Month 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   25/03/2025 
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="0"
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 study plans to conduct a cohort monitoring study on the use of Imeglimin in type 2 diabetic patients , incorporating both retrospective and prospective approaches. The research studies on the safety and efficacy of Imeglimin have already been conducted in various countries including japan . This study on Imeglimin aims to address several gaps in the current understanding of type 2 diabetes management.

        AIM: The study aims to determine the Safety, Efficacy, and Patient Acceptability of Imeglimin in the  management of Type 2 Diabetes Mellitus.

       OBJECTIVE: To assess the Safety, Efficacy, and Patient Acceptability of Imeglimin in the management of  Type 2 Diabetes Mellitus.

STUDY DESIGN: Observational Prospective Cohort Study.

SAMPLE SIZE: 70.

Inclusion criteria:

  1.  The study population includes patients who are 18 years of age and older .
  2.  Patients only with type 2 diabetes mellitus .
  3.  Patients who are receiving Imeglimin.
  4. Patients receiving Imeglimin for atleast 3 months.

Exclusion criteria:

  1. Patient who are intolerant to imeglimin.
  2. Patient who have stopped taking imeglimin .
  3. Patient unwilling to give written informed consent.

Clinical Outcomes:

Primary Clinical Outcomes :

Change in HbA1c Levels: Measure the reduction in HbA1c from baseline to the end of the study. A significant decrease indicates improved glycemic control.

Fasting Blood Glucose : Monitor changes in fasting blood glucose levels.

Change in Body Weight: Measure the reduction in body weight in kg from baseline to follow-up.

Change in Body Mass Index : Assess changes in BMI, which provides insight into overall weight status

       
       Secondary Clinical Outcomes:
         
        Weight Loss: Assess weight reduction and changes in BMI over time. Document waist circumference to track central obesity.

        Fasting and Postprandial Glucose: Monitor reductions in fasting plasma glucose and postprandial glucose levels.

        Lipid Profile: Track improvements in lipid levels like total cholesterol, LDL, HDL, and triglycerides to evaluate cardiovascular health.

        Blood Pressure: Observe changes in both systolic and diastolic blood pressure to assess any cardiovascular benefits.

       EXPECTED OUTCOME:

  1.  The study’s safety outcomes will focus on identifying adverse drug reactions associated with imeglimin, including their frequency and severity.
  2.  The efficacy outcomes of the study will focus on the improvement in glycemic control among patients with Type 2 Diabetes Mellitus. This will be assessed by observing reductions in HbA1c levels over the study period, along with decreases in both fasting and postprandial blood glucose levels.
  3.  The study will likely support oral Imeglimin as an effective and safe treatment option, contributing to better management of diabetes for the population. These findings could guide clinical protocols in tertiary care hospitals.
 
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