| CTRI Number |
CTRI/2023/08/056584 [Registered on: 17/08/2023] Trial Registered Prospectively |
| Last Modified On: |
23/08/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Effectiveness and Safety of Imeglimin and Metformin monotherapy in type 2 Diabetes: A Study |
|
Scientific Title of Study
|
Comparison of Effectiveness and Safety of Imeglimin and Metformin monotherapy in type 2 Diabetes Mellitus: A Randomised Open Label Parallel Group Phase IV Controlled Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arjun Baidya |
| Designation |
Associate Professor |
| Affiliation |
NRS Medical College and Hospital |
| Address |
Department of Endocrinology,
NRS Medical College and Hospital,
138, AJC Bose Road,
Kolkata- 700014
Kolkata
WEST BENGAL
700014
India |
| Phone |
6351239897 |
| Fax |
|
| Email |
arjun.baidya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arjun Baidya |
| Designation |
Associate Professor |
| Affiliation |
NRS Medical College and Hospital |
| Address |
Department of Endocrinology,
NRS Medical College and Hospital,
138, AJC Bose Road,
Kolkata- 700014
WEST BENGAL
700014
India |
| Phone |
6351239897 |
| Fax |
|
| Email |
arjun.baidya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arjun Baidya |
| Designation |
Associate Professor |
| Affiliation |
NRS Medical College and Hospital |
| Address |
Department of Endocrinology,
NRS Medical College and Hospital,
138, AJC Bose Road,
Kolkata- 700014
WEST BENGAL
700014
India |
| Phone |
6351239897 |
| Fax |
|
| Email |
arjun.baidya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Arjun Baidya Dept of Endocrinology at NRS Medical College and Hospital 138 AJC Bose Road Kolkata 700014 |
|
|
Primary Sponsor
|
| Name |
Other Self |
| Address |
NRS Medical College and Hospital,
138, AJC Bose Road,
Kolkata -700014,
West Bengal |
| Type of Sponsor |
Other [Investigator] |
|
|
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 Arjun Baidya |
NRS Medical College and Hospital |
Dept of Endocrinology, 3rd floor,
138, AJC Bose Road,
Kolkata- 700014
Kolkata
WEST BENGAL |
6351239897
arjun.baidya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NRS Medical College and Hospital |
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
|
| Type |
Name |
Details |
| Intervention |
Imeglimin |
1000 mg twice daily Orally for 16 weeks |
| Comparator Agent |
Metformin |
1000 mg twice daily |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Newly Diagnosed cases with Type 2 Diabetes Mellitus
HbA1c>7.5% and <9% |
|
| ExclusionCriteria |
| Details |
Female patient who are pregnant and lactating
Patients on any other glucose lowering agent
Establised Cardiovascular disease, Compromised renal Function(eGFR<60) AND Liver function (enzymes>3 ULN) and psychiatric illness |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change of HBA1c at week 16th with respect to week 0 |
Change of HBA1c at week 16th with respect to week 0 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in FPG & PPPG
Adverse reaction
Adherence to medication |
Week 8,12,16 |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
31/08/2023 |
| 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="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Diabetes mellitus (DM) is a syndrome characterized by chronic hyperglycemia and disturbances of carbohydrate, fat, and protein metabolism due to deficiency of insulin (type 1) or insensitivity of the target tissues to insulin (type 2). Oral therapy for type 2 diabetes, when used appropriately, can safely assist patients to achieve glycemic target in the short term to medium term. In the current standard of care treatment for newly diagnosed type 2 diabetes mellitus patient, Metformin still finds a place as the first line drug. Although lifestyle modification remains the mainstay for all patients of type 2 diabetes. The therapeutic armamentarium for diabetes is growing day-by-day. In this rapidly growing list of pharmacotherapy for type 2 diabetes is a very new group of oral antidiabetic tetrahydrotriazineâ€containing drug Imeglimin. |