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CTRI Number  CTRI/2024/04/065835 [Registered on: 16/04/2024] Trial Registered Prospectively
Last Modified On: 15/04/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   Study of efficacy and side effects of imeglimin as an antidiabetic agent as single drug or as an add on drug 
Scientific Title of Study   To study the efficacy and safety of imeglimin as monotherapy or as an add on therapy with existing antidiabetic agents in North Indian population with type 2 diabetes 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Abhinav Garg 
Designation  Assistant Professor 
Affiliation  Adesh institute of medical sciences and research 
Address  B-306, Adesh Campus, Adesh institute of medical sciences and research, NH-7 Barnala road, Bathinda, Punjab

Bathinda
PUNJAB
151101
India 
Phone  7888993130  
Fax    
Email  abhinavgarg24@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Abhinav Garg 
Designation  Assistant Professor 
Affiliation  Adesh institute of medical sciences and research 
Address  B-306, Adesh Campus, Adesh institute of medical sciences and research, NH-7 Barnala road, Bathinda, Punjab


PUNJAB
151101
India 
Phone  7888993130  
Fax    
Email  abhinavgarg24@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Abhinav Garg 
Designation  Assistant Professor 
Affiliation  Adesh institute of medical sciences and research 
Address  B-306, Adesh Campus, Adesh institute of medical sciences and research, NH-7 Barnala road, Bathinda, Punjab


PUNJAB
151101
India 
Phone  7888993130  
Fax    
Email  abhinavgarg24@yahoo.co.in  
 
Source of Monetary or Material Support  
Adesh institute of medical sciences and research, NH-7, Barnala road, Bathinda, Punjab, Pin 151101 
 
Primary Sponsor  
Name  Abhinav Garg 
Address  B-306, Adesh Campus, Adesh institute of medical sciences and research, NH-7 Barnala road, Bathinda, Punjab 
Type of Sponsor  Other [Self] 
 
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 Abhinav Garg  Adesh institute of medical sciences and research  Room no. 1523, Department of General Medicine, Ground floor, Adesh hospital, Adesh institute of medical sciences and reseach, NH-7, Barnala road, Bathinda, Punjab
Bathinda
PUNJAB 		 7888993130

abhinavgarg24@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee, Adesh University, Bathinda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  The drug will be given in a dose of 1000 mg twice a day orally for a period of 6 months. 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients who are 18 years or older with type 2 diabetes with diet/exercise alone or together with a single or combination antidiabetic therapy will be enrolled in this 24 weeks study.
Inclusion criteria for the patients who will receive imeglimin monotherapy includes: Patients who were treated with diet and exercise without an antihyperglycaemic agent during at least 12 weeks prior to screening. Hba1c of 7.0%-10.5%, and an estimated glomerular filtration rate(as per MDRD equation) greater than or equal to 50 ml/min/1.73m2.
Inclusion criteria for the patients who will receive imeglimin add on therapy includes: Patients who were treated with diet and exercise plus treatment with an antihyperglycaemic agent that are alpha-glucosidase inhibitors(AGI), biguanide(BIG), dipeptidyl peptidase-4 inhibitors(DPP4-I), glinide(GLIN), injectable glucagon-like inhibitor(GLP1-RA), Sodium-glucose co-transporter inhibitor(SGLT2-I), sulphonylurea(SU), or thiazolidinedione(TZD), will be included in the long term combination therapy. Type, dose and regimen of background antidiabetic therapy will be unchanged for at least 12 weeks prior to screening. Hba1c of 7%-10.5%, and an estimated glomerular filteration rate(as per MDRD equation) greater than or equal to 50 ml/min/1.73m2. 
 
ExclusionCriteria 
Details  Pregnant and lactating women,Cirrhosis- CTP class C, Insulin therapy 30 days prior to screening.
Heart failure-NYHA class III or IV and acute coronary events or cerebrovascular event 24 weeks before screening
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
HBa1c reduction and adeverse effects  3 months and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Lipid profile reduction  3 months and 6 months 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   28/04/2024 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  Data will be avaiable in soft copy form from principal investigator

  6. For how long will this data be available start date provided 01-05-2024 and end date provided 31-05-2028?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - For more information contact at abhinavgarg24@yahoo.co.in
Brief Summary  

After screening, all participants will receive 1000mg Imeglimin twice a day for 24 weeks either as monotherapy in treatment naïve patients or as combination therapy in those who are already receiving oral antidiabetic therapy. Patients will be assessed(physical examination, vital signs, efficacy and safety assessments) at week 12 and 24 after starting the treatment.

In case of combination therapy-

metformin (500- 2500 mg) + vildagliptin (50-100 mg) or,

metformin (500- 2500 mg) + dapagliflozin (5- 10 mg) or ,

metformin (500- 2500 mg) + glimepride (1- 8 mg) or,

metformin (500- 2500 mg) + sitagliptin (50- 100 mg) or,

metformin (500- 2500 mg) + glimepride (1- 8 mg) + pioglitazone (15 mg)

or any other combination.

Above combinations will be used as combination therapy and Imeglimin 1000mg as add on antidiabetic agent will be used.

Patients with unacceptable hyperglycemia (i.e. fasting plasma glucose >250 mg/dl from baseline to week 4 or any HBA1C of at least 10.5% for long term monotherapy group and >10.5% for long term combination therapy) should discontinue the study drug and a rescue therapy will be initiated. The initiation, choice and dose of rescue medication used will be at the discretion of the physician, according to the local prescribing information, but insulin will not be used. Any increase in the dosing of background antidiabetic therapy will be considered as a rescue medication.

 

 
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