| CTRI Number |
CTRI/2024/11/076574 [Registered on: 11/11/2024] Trial Registered Prospectively |
| Last Modified On: |
11/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study on safety and effectiveness of an anti-diabetic drug in Type-2 Diabetes Mellitus Patients |
|
Scientific Title of Study
|
A Non-Interventional, Multi-center, Post approval, ObseRvatiOnal Study to Understand Safety and EffectiVEness of IMEglimin SR as Add on TreatmeNT in Indian T2DM Patients |
| Trial Acronym |
Improvement |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| TPL2404486 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shrikant Somani |
| Designation |
MD Medicine, DNB Endocrinology |
| Affiliation |
|
| Address |
Somani diabetes and endocrine care center,
508, fifth floor, Above Asopalav showroom, Bhimjipura, Nava Vadaj, Ahmedabad
Ahmadabad
GUJARAT
380013
India |
| Phone |
09825074703 |
| Fax |
|
| Email |
drshrikantsomani@proton.me |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Kalra |
| Designation |
Chairman of the Scientific Committee |
| Affiliation |
Bharti Hospital |
| Address |
H.No 104, Sector 14, Karnal, Haryana
Kunjpura Rd, Saini Colony, Wazir Chand Colony, Sector 12, Karnal, Haryana 132001
Karnal
HARYANA
132001
India |
| Phone |
9896048555 |
| Fax |
|
| Email |
brideknl@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lokesh RV |
| Designation |
|
| Affiliation |
Torrent Pharmaceuticals Ltd. |
| Address |
Torrent Pharma Limited, Off Ashram Road, Ahmedabad 380009
Ahmadabad
GUJARAT
380009
India |
| Phone |
7069000601 |
| Fax |
|
| Email |
LokeshRV@torrentpharma.com |
|
|
Source of Monetary or Material Support
|
| Torrent Pharmaceuticals Ltd., Ashram Road - Navrangpura, Ahmedabad, GUJARAT-380009, India |
|
|
Primary Sponsor
|
| Name |
Torrent Pharmaceuticals Ltd. |
| Address |
Torrent Pharmaceuticals Ltd., Ashram Road - Navrangpura, Ahmedabad, GUJARAT-380009, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Shrikant Somani |
Somani diabetes and endocrine care center |
Somani diabetes and endocrine care center,
508, fifth floor, Above Asopalav showroom, Bhimjipura, Nava Vadaj, Ahmedabad
Ahmadabad
GUJARAT |
09825074703
drshrikantsomani@proton.me |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sangini Hospital Ethics Committee |
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 |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female T2DM patients 18 to 75 years.
2. T2DM cases with uncontrolled Hyperglycemia either with mono or dual or triple (as per discretion of physician) OADs or insulin and having HbA1c 7-10 percent |
|
| ExclusionCriteria |
| Details |
1. HbA1c greater than 10 percent
2. T1DM
3. Clinical history of hypersensitivity or DKA
4. Clinical history of Active or uncontrolled ASCVD or Heart failure or Retinopathy or Neuropathy
5. Clinical history of CKD (eGFR less than 45 ml per min per m2) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Mean change from baseline in HbA1c
2. Mean change in FPG, 2-hr PPBG
|
1. at week 12
2. from baseline at week 4 and week 12
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety of Imeglimin SR |
at week 4 and week 12 |
| Mean change from baseline in HbA1c in patients with DPP4i/Met, SGLT2i/Met, SU/Met and/or insulin and/or GLP1a |
at week 12 |
| Change from baseline in HbA1c assessment for Overall and CV risk cases (with QRISK-3 score greater than 10 percent involving multiple risk factors, LVD, Stage 3a CKD, Age greater than or equal to 40y, Personal or Family History of ASCVD) |
at week 12 |
| Change from baseline in HbA1c assessment for cases with Young Onset Diabetes (Age 18 to 40y) |
at week 12 |
| Treatment responders with target HbA1c achievement of less than 7 percent in Overall, CV risk and YoD cases |
at week 12 |
| Changes in dose of baseline sulfonyl urea/insulin |
at 4 and 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="1750"
Sample Size from India="1750"
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)
|
25/11/2024 |
| 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="0"
Months="3"
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
|
Study design: Post approval, observational, single arm, multicentre study
Objective: To
assess the Safety and Effectiveness of Imeglimin SR as an add on treatment in
T2DM patients in India.
Duration of observation: 12 weeks
Study population: Uncontrolled T2DM patients with HbA1c 7-10 percent. |