Compares metformin and berberine in type 2 diabetes by TCF7L2 gene type
Tests metformin and berberine in adults with new type 2 diabetes by gene type.
Plain-language title generated from the registry record
Registry title: Comparative Efficacy of Metformin and Berberine Among TCF7L2 (rs7903146) TT vs. CC Genotype Carriers With Type 2 Diabetes
Key facts
- Where
- Novosibirsk, RussiaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 30 and 65 years old?
Source: NCT06911983, who can take part
Where in Russia
- Center for New Medical TechnologiesNovosibirsk, RussiaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- S.LAB (SOLOWAYS)
- Trial code
- NCT06911983
- Record updated
- 20 April 2025
- Original description
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 is to assess changes in HbA1c between metformin and berberine treated groups within each genotype. Secondary outcomes include fasting and postprandial glucose, insulin levels, HOMA-IR, body weight/BMI, lipid profile and adverse events.Read full original descriptionShow less
Comparative Efficacy of Metformin and Berberine Among TCF7L2 (rs7903146) TT vs. CC Genotype Carriers With Type 2 Diabetes: A Pilot Randomized Clinical Study
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 is to assess changes in HbA1c between metformin and berberine treated groups within each genotype. Secondary outcomes include fasting and postprandial glucose, insulin levels, HOMA-IR, body weight/BMI, lipid profile and adverse events.
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.
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); Known allergy or intolerance to metformin or berberine; Pregnancy or lactation; Participation in another clinical trial within the last 3 months; TC genotype (excluded).