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CTRI Number  CTRI/2024/07/069793 [Registered on: 01/07/2024] Trial Registered Prospectively
Last Modified On: 28/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Association of genetic factors present in people of southern Indian with their response to blood sugar lowering medications namely metformin and glimepiride 
Scientific Title of Study   Influence of SLC22A1 480C to G and CYP2C93 1075A to C genetic polymorphisms on poor response to metformin and glimepiride combined therapy in South Indian Type 2 Diabetes Mellitus (T2DM) patients 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aditya V Reddy 
Designation  Junior resident 
Affiliation  Jawaharlal institute of post graduate medical education and research Puducherry  
Address  Institute block, 3rd Floor, Genomics Lab, Department of Pharmacology, JIPMER Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  7021139954  
Fax  605006  
Email  adityalvr16@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. R. Kesavan 
Designation  Associate Professor 
Affiliation  Jawaharlal institute of post graduate medical education and research Puducherry  
Address  Institute block, 3rd floor, Department of Pharmacology, JIPMER Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9360532592  
Fax  605006  
Email  jd1083@jipmer.ac.in  
 
Details of Contact Person
Public Query  
Name  Aditya V Reddy 
Designation  Junior resident 
Affiliation  Jawaharlal institute of post graduate medical education and research Puducherry  
Address  Institute block, 3rd Floor, Genomics Lab, Department of Pharmacology, JIPMER Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  7021139954  
Fax  605006  
Email  adityalvr16@gmail.com  
 
Source of Monetary or Material Support  
JIPMER intramural fund, JIPMER Puducherry, Puducherry, India, 605006 
 
Primary Sponsor  
Name  JIPMER Intramural Fund 
Address  JIPMER, Dhanvantri Nagar, Gorimedu, Puducherry, 605006 
Type of Sponsor  Government medical college 
 
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 Aditya V Reddy  JIPMER PUDUCHERRY  Genomics Laboratory, Department of Pharmacology. Diabetes Clinic, OPD No. 211,212. Endocrinology clinic, OPD No.214.
Pondicherry
PONDICHERRY 		 7021139954

adityalvr16@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee (Human studies) for observational studies  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified 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  Cases
Patients started on metformin and glimepiride therapy who are on a stable drug regimen for at least 6 months and reached the maximum tolerated dose and or required other addon antidiabetic drug and their Hb1Ac cutoff more than equal to 8
Patients with type 2 diabetes mellitus of South Indian origin. South Indian origin is defined as patients with history of three generations living in any of the southern states namely Puducherry Tamil Nadu Kerala Karnataka Andhra Pradesh and Telangana and speaking the respective local language as mother tongue
Both male and female gender
Age 30 years and above

Controls
Patients who are on a stable drug regimen for at least 6 months started on metformin and glimepiride and reached the maximum tolerated dose and other addon antidiabetic drug in addition to above two drugs and their Hb1Ac less than 8
Patients with type 2 diabetes mellitus of South Indian origin. South Indian origin is defined as patients with history of three generations living in any of the southern states namely Puducherry Tamil Nadu Kerala Karnataka Andhra Pradesh and Telangana and speaking the respective local language as mother tongue
Both male and female gender
Age 30 years and above




 
 
ExclusionCriteria 
Details  Cases
Patients with a history of clinically proven renal or hepatic impairment

Patients taking cationic medications like cimetidine furosemide nifedipine

Drugs inhibiting CYP2C9 like Ketoconazole Phenytoin Amiodarone Fluoxetine

Drugs enhancing CYP2C9 Rifampicin Carbamazepine
Primidone

Pregnancy and lactation

Patients who regularly consume alcohol

Patients who diagnosed to have type 1 diabetes, maturity onset diabetes of the young and secondary causes due to endocrinopathies or chronic intake of steroidal drugs

Controls
Patients with a history of clinically proven renal or hepatic impairment

Patients taking cationic medications like cimetidine furosemide nifedipine

Drugs inhibiting CYP2C9 like Ketoconazole Phenytoin Amiodarone Fluoxetine

Drugs enhancing CYP2C9 like Rifampicin Carbamazepine Primidone

Pregnancy and lactation

Patients who regularly consume alcohol

Patients who diagnosed to have type 1 diabetes or maturity onset diabetes of the young and secondary causes due to endocrinopathies 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 SLC22A1 GG and CYP2C9 1075 AA genotypes and poor response to metformin glimepiride combined therapy in Type 2 Diabetes Mellitus patients of south Indian origin  This will be assessed at baseline. 
 
Secondary Outcome  
Outcome  TimePoints 
To study the effect of combined gene gene interaction of SLC22A1 480 C to G & SLC22A1 rs622342 & CYP2C93 1075 A to C affecting dose requirement of metformin & glimepiride combination therapy  Thus will be done 6 months after the beginning of patient recruitment.  
 
Target Sample Size   Total Sample Size="220"
Sample Size from India="220" 
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)   15/07/2024 
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="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 study is being conducted to analyze the influence of SLC22A1 480 C TO G and CYP2C93 1075 A TO C genetic polymorphisms on poor response to metformin and glimepiride combined therapy in patients with type 2 diabetes mellitus from southern India. The current prevalence of Diabetes mellitus is around 101 million in India. Type 2 diabetes accounts for 87% to 91% of the global burden of diabetes. Hence it is of paramount importance to study the genetic factors which may lead to poor response to anti diabetic treatment which may contribute to the increasing morbidity due to diabetes. If positive associations are found between the above mentioned genetic polymorphisms and poor response to diabetes treatment, we can then formulate dose modifications for the selected patients, which will lead to better treatment outcomes. This will lead to a reduction in the burden of diabetes on our healthcare system and the society as whole.   
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