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Impact of Genetic Variations on the Effectiveness of Metformin and Glimepiride Treatment in South Indian People with Type 2 Diabetes

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. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/11/097215
Enrollment
240
Registered
2025-11-11
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications

Interventions

Intervention1: Nil: Nil

Sponsors

INTRAMURAL RESEARCH FUND COMMITTEE JIPMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Secondary

MeasureTime frame
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.Timepoint: 4 weeks

Primary

MeasureTime frame
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.Timepoint: 4 weeks

Countries

India

Contacts

Public ContactDr R Kesavan

Jawaharlal Institute of Postgraduate Medical Education and Research

kes7ramasamy@gmail.com9360532592

Outcome results

None listed

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