| CTRI Number |
CTRI/2023/06/053822 [Registered on: 13/06/2023] Trial Registered Prospectively |
| Last Modified On: |
15/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A diabetic study to find the safety and efficacy of newer drug Imeglimin. |
|
Scientific Title of Study
|
A Comparative study to Evaluate the Efficacy and Safety of Imeglimin with Metformin versus Metformin in Type 2 Diabetes Mellitus patients in a tertiary care hospital,Chengalpattu-A Randomised Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shaki Sam |
| Designation |
Postgraduate |
| Affiliation |
Karpaga Vinayaga Institute of Medical sciences & Research Centre |
| Address |
Department of Pharmacology,
Karpaga Vinayaga Institute of Medical Sciences and Research Centre
GST Road,Chinna Kolambakkam,
Madhuranthagam Taluk,
Chengalpattu district,
Pin:603308
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
6380757173 |
| Fax |
|
| Email |
drshakisam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr B Prathap |
| Designation |
Professor |
| Affiliation |
Karpaga Vinayaga Institute of Medical sciences & Research Centre |
| Address |
Department of Pharmacology,
Karpaga Vinayaga Institute of Medical Sciences and Research Centre
GST Road,Chinna Kolambakkam,
Madhuranthagam Taluk,
Chengalpattu district,
Pin:603308
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
9600283380 |
| Fax |
|
| Email |
prathap.thap@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shaki Sam |
| Designation |
Postgraduate |
| Affiliation |
Karpaga Vinayaga Institute of Medical sciences & Research Centre |
| Address |
Department of Pharmacology,
Karpaga Vinayaga Institute of Medical Sciences and Research Centre
GST Road,Chinna Kolambakkam,
Madhuranthagam Taluk,
Chengalpattu district,
Pin:603308
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
6380757173 |
| Fax |
|
| Email |
drshakisam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Karpaga Vinayaga Institute of Medical Sciences and Research Centre |
|
|
Primary Sponsor
|
| Name |
Dr Shaki Sam |
| Address |
Department of Pharmacology,
Karpaga Vinayaga Institute of Medical Sciences and Research Centre. |
| Type of Sponsor |
Other [Other] |
|
|
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 |
| Dr Shaki Sam |
Karpaga Vinayaga Institute of Medical Sciences and Research Centre |
Department of Medicine & Department of Pharmacology,
Chinna Kolambakkam,
Madhuranthagam Taluk,
Chengalpattu district,
Pin:603308
Kancheepuram
TAMIL NADU |
6380757173
drshakisam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee of Karpaga Vinayaga Institute of Medical Sciences & Research centre,Madhuranthagam. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Imeglimin |
1000mg for 3 months twice daily |
| Comparator Agent |
Placebo |
Same as the Original drug |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1)Male & Female population
2)HbA1c >6.5 and <10
3)Patients willing to participate and given written informed consent |
|
| ExclusionCriteria |
| Details |
1)Those who are on insulin therapy or any injectable glucose lowering drugs in the past 30 days.
2)Pregnant and lactating mother
3)Patients with impaired hepatic or renal function
4)Patients with hypertension,congestive cardiac failure,ischemic heart disease.
5)Clinically significant micro vascular and macro vascular complications
6)Patients who didn’t give written informed consent. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the primary efficacy outcome change of HbA1c level |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the changes in baseline fasting plasma glucose and pro insulin/insulin ratio |
3 months |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
26/06/2023 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
1) Duration of data collection will be 3 months. 2) The participants will be selected by the given inclusion and exclusion criteria. 3) Selected study participants will be Randomized using Simple Random Method(Computerised Random Number generation method) into 2 groups ie, Group A & Group B. 4)Samples required for baseline investigations for the study will be collected(HbA1c,FBS,PPBS,RFT,LFT,Lipid Profile,Urine microalbiminuria,12 lead ECG). 5)Group A will be treated with Imeglimin+Metformin & the Group B with Metformin+ Placebo.The Placebo is of similar size & color of the test drug. 6)During 4th & 8th week follow up FBS, PPBS & Urine microalbuminuria will be collected. 7)During 12th week follow up all baseline investigations for the study will be repeated. 8)All the collected data will be compared and analysis will be done. |