Status:
NOT_YET_RECRUITING
Comparative Efficacy of Metformin and Berberine Among TCF7L2 (rs7903146) TT vs. CC Genotype Carriers With Type 2 Diabetes
Lead Sponsor:
S.LAB (SOLOWAYS)
Collaborating Sponsors:
Center for New Medical Technologies, Novosibirsk, Russia
Conditions:
Diabetes Mellitis
Eligibility:
All Genders
30-65 years
Phase:
NA
Brief Summary
This pilot 12-week randomized open-label study compares metformin and berberine in newly diagnosed type 2 diabetes patients stratified by the TCF7L2 (rs7903146) genotype (TT vs. CC). The primary goal ...
Eligibility Criteria
Inclusion
- Adults aged 30-65 years;
- Newly diagnosed T2DM ≤1 year;
- Baseline HbA1c: 7.0-9.0% (53-75 mmol/mol);
- No prior use of antihyperglycemic agents or ≤4 weeks of usage;
- Willing to sign informed consent and undergo TCF7L2 genotyping;
- TT or CC genotype (rs7903146)
Exclusion
- Severe comorbidities (hepatic, renal, cardiac dysfunction);
- Pregnancy or lactation;
- Known allergy or intolerance to metformin or berberine;
- Participation in another clinical trial within the last 3 months;
- TC genotype (excluded).
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06911983
Start Date
July 1 2025
End Date
March 1 2026
Last Update
April 20 2025
Active Locations (1)
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1
Center for New Medical Technologies
Novosibirsk, Russia