Comparative Efficacy of Metformin and Berberine Among TCF7L2 (rs7903146) TT vs. CC Genotype Carriers With Type 2 Diabetes
NCT ID: NCT06911983
Last Updated: 2025-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2025-07-01
2026-03-01
Brief Summary
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The central hypothesis is that berberine, through its additional effect on TCF7L2-linked pathways, will provide superior glycemic control in high-risk TT carriers compared to metformin, whereas both treatments will yield comparable results in CC carriers. By enrolling only TT and CC genotypes, this study aims to estimate effect sizes and feasibility, guiding a future, larger-scale trial on genotype-tailored diabetes therapies.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Metformin Group
Initial dose: 500 mg twice daily
* Titration: increased to 1,000 mg twice daily by Week 2 if tolerated
* Maximal dose: 2,000 mg/day
Metformin
Metformin • Initial dose: 500 mg twice daily • Titration: increased to 1,000 mg twice daily by Week 2 if tolerated • Maximal dose: 2,000 mg/day
Berberine Group
* Dose: 500 mg three times daily (1,500 mg/day total)
* Formulation: standardized berberine HCl tablets
* Duration: 12 weeks
Berberine
Berberine
* Dose: 500 mg three times daily (1,500 mg/day total)
* Formulation: standardized berberine HCl tablets
* Duration: 12 weeks
Interventions
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Metformin
Metformin • Initial dose: 500 mg twice daily • Titration: increased to 1,000 mg twice daily by Week 2 if tolerated • Maximal dose: 2,000 mg/day
Berberine
Berberine
* Dose: 500 mg three times daily (1,500 mg/day total)
* Formulation: standardized berberine HCl tablets
* Duration: 12 weeks
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* Pregnancy or lactation;
* Known allergy or intolerance to metformin or berberine;
* Participation in another clinical trial within the last 3 months;
* TC genotype (excluded).
30 Years
65 Years
ALL
No
Sponsors
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Center for New Medical Technologies, Novosibirsk, Russia
OTHER
S.LAB (SOLOWAYS)
OTHER
Responsible Party
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Locations
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Center for New Medical Technologies
Novosibirsk, , Russia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SW026
Identifier Type: -
Identifier Source: org_study_id
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