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Effect of genetic polymorphism on antidiabetic medication in Indian patients with Type 2 Diabetes

Evaluation of effect of genetic polymorphism on antidiabetic medication in Indian patients with Type 2 Diabetes for development of a pharmacogenomic test for T2DM patients - NIL

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/10/058414
Enrollment
200
Registered
2023-10-06
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Chellaram Diabetes Research Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Subjects from Indian population diagnosed with Type 2 diabetes according to the criteria of the American Diabetes Association. Subjects having with HbA1c in the range of 7.5–12% and either on monotherapy or combination therapy on antidiabetic drugs. Subjects over 18 years old and below 60 years Subjects who agree with the written informed consent to participate in the study

Exclusion criteria

Exclusion criteria: Other than Indian ethnicity Under 18 years old Pregnant or lactating women Patients with malignancies, and chronic kidney disease stage 3–5, liver cirrhosis Presently suffering from congestive heart failure requiring pharmacologic treatment (medical history) Past history of urinary or gastric retention or narrow-angle glaucoma Presently severe anaemia Taking a medication that could confound study results, such as known substrates or inhibitors of OCT3 and MATE1, such as cimetidine. They do not provide consent to participate in the study.

Design outcomes

Primary

MeasureTime frame
Genetic association of response to anti-diabetic drugs with a particular SNP or SNPs Responders and non-responders based on HbA1c % (less than 7% and above 7%) - allele frequency of each SNP Timepoint: 0 month 3 months 6 months

Secondary

MeasureTime frame
Information on genetic polymorphism and variant allele frequency at the studied loci in the study population will be obtained. Development of a SNP Genotyping assay for pharmacogenomic assessment of T2D patients. Development of matrix for treatment decision based on the pharmacogenomic information. Timepoint: After 6 months

Countries

India

Contacts

Public ContactYashwant Chavan

geneOmbio Technologies Pvt Ltd

yashwant.chavan@geneombiotechnologies.com9766363481

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026