| CTRI Number |
CTRI/2025/11/097215 [Registered on: 11/11/2025] Trial Registered Prospectively |
| Last Modified On: |
10/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Impact of Genetic Variations on the Effectiveness of Metformin and Glimepiride Treatment in South Indian People with Type 2 Diabetes" |
|
Scientific Title of Study
|
Influence of SLC22A1 rs628031 and KCNJ11 rs5219 genetic polymorphisms on poor therapeutic response to metformin and glimepiride combined therapy in Type 2 Diabetes Mellitus (T2DM) patients belonging to South India. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 028, Dated 10/07/2025 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr R Kesavan |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Room No 4026,Third Floor, Institute Block, Department of Pharmacology, Jawaharlal Institute of Postgraduate Medical Education and Research
JIPMER Campus Rd, Gorimedu,
Dhanvantari Nagar,
Puducherry, 605006.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9360532592 |
| Fax |
|
| Email |
kes7ramasamy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R Kesavan |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Room No 4026,Third Floor, Institute Block, Department of Pharmacology, Jawaharlal Institute of Postgraduate Medical Education and Research
JIPMER Campus Rd, Gorimedu,
Dhanvantari Nagar,
Puducherry, 605006.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9360532592 |
| Fax |
|
| Email |
kes7ramasamy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R Kesavan |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Room No 4026, Third Floor, Institute Block, Department of Pharmacology, Jawaharlal Institute of Postgraduate Medical Education and Research
JIPMER Campus Rd, Gorimedu,
Dhanvantari Nagar,
Puducherry, 605006.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9360532592 |
| Fax |
|
| Email |
kes7ramasamy@gmail.com |
|
|
Source of Monetary or Material Support
|
| INTRAMURAL RESEARCH FUND COMMITTEE, Jawaharlal Institute of Postgraduate Medical Education and Research
JIPMER Campus Rd, Gorimedu,
Dhanvantari Nagar,
Puducherry, India, 605006.
|
|
|
Primary Sponsor
|
| Name |
INTRAMURAL RESEARCH FUND COMMITTEE JIPMER |
| Address |
JIPMER Campus Rd, Gorimedu,
Dhanvantari Nagar,
Puducherry, India, 605006. |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Suresh Reddy |
Jawaharlal Institute of Postgraduate Medical Education and Research |
Endocrinology OPD, Room No 214, Department of Endocrinology, Super Specialty Block,
JIPMER Campus Rd, Gorimedu,
Dhanvantari Nagar,
Puducherry, 605006.
Pondicherry
PONDICHERRY |
9148376302
sureshreddy.sirwar@gmail.com |
| Dr Suresh Reddy |
Jawaharlal Institute of Postgraduate Medical Education and Research |
Diabetic OPD, Room No 75, Department of Medicine, OPD Block, JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006.
Pondicherry
PONDICHERRY |
9148376302
sureshreddy.sirwar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE FOR OBSERVATIONAL STUDIES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
A) For Cases
1. Patients started on metformin and glimepiride therapy who are on a stable drug regimen for atleast 6 months and reached the maximum tolerated dose and or or required other add-on antidiabetic drug and their Hb1Ac levels more than 7 percent.
2. Patients with type 2 diabetes mellitus of South Indian origin. South Indian origin is defined as patients with a history of three generations living in any of the southern States (Puducherry, Tamil Nadu, Kerala, Karnataka, Andhra Pradesh and Telangana) and speaking the respective local language as their mother tongue.
3. Both male and female gender.
4. Age 30 years and above.
B) For Controls
1. Patients who are on a stable drug regimen of metformin, glimepiride for atleast 6 months and their Hb1Ac levels less than or equal to 7 percent.
2. Patients with type 2 diabetes mellitus of South Indian origin. South Indian origin is defined as patients with a history of three generations living in any of the southern States (Puducherry, Tamil Nadu, Kerala, Karnataka, Andhra Pradesh and Telangana) and speaking the respective local language as their mother tongue.
3. Both male and female gender.
4. Age 30 years and above.
|
|
| ExclusionCriteria |
| Details |
A) For Cases
1. Poor adherence to combination therapy ( adherence rate of less than 90 percent will be considered as poor adherence).
2. Patients with a history of clinically proven renal or hepatic impairment.
3. Patients taking cationic medications like cimetidine, furosemide, nifedipine.
4. Pregnancy and lactation.
5. Patients who regularly consume alcohol [more than 4 standard drinks per day(1 standard drink equals to 10g of pure alcohol)].
6. Patients who diagnosed to have type 1 diabetes, maturity-onset diabetes of the young (MODY), and secondary causes due to endocrinopathies, and chronic intake of steroidal drugs.
B) For Controls
1. Patients with a history of clinically proven renal or hepatic impairment.
2. Patients taking cationic medications like cimetidine, furosemide, nifedipine.
3. Pregnancy and lactation.
4. Patients who regularly consume alcohol [more than 4 standard drinks per day (1 standard drink equals to 10g of pure alcohol)
5. Patients who are diagnosed to have type 1 diabetes, maturity-onset diabetes of the young (MODY) and secondary causes due to endocrinopathies, and chronic intake of steroidal drugs.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the association between variant genotypes of SLC22A1 (rs628031) & KCNJ11 (rs5219) and poor therapeutic response to metformin-glimepiride combined therapy in Type 2 Diabetes Mellitus patients of South Indian origin. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To investigate the role of SLC22A1 (rs628031) & KCNJ11 (rs5219) polymorphisms in affecting dose requirements of metformin-glimepiride combination therapy among responders with type 2 diabetes mellitus. |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
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)
|
25/11/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 is a case-control pharmacogenetic study for evaluating whether SLC22A1 rs628031 and KCNJ11 rs5219 genetic polymorphisms predict poor glycemic response to metformin and glimepiride combined therapy in type 2 diabetes mellitus patients belonging to south India. |