NCT06911983Not yet recruiting
Comparative Efficacy of Metformin and Berberine Among TCF7L2 (rs7903146) TT vs. CC Genotype Carriers With Type 2 Diabetes
Comparative Efficacy of Metformin and Berberine Among TCF7L2 (rs7903146) TT vs. CC Genotype Carriers With Type 2 Diabetes: A Pilot Randomized Clinical Study
Source: ClinicalTrials.gov · Last updated 20 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 28 Mar 2025
- Start date
- 1 Jul 2025
- Primary completion date
- 1 Dec 2025
- Lead sponsor
- S.LAB (SOLOWAYS)
- Diseases
- Type 2 diabetes
- NCT number
- NCT06911983
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 1 Jul 2025 to the primary completion date, 1 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Severe comorbidities (hepatic, renal, cardiac dysfunction);
- Known allergy or intolerance to metformin or berberine;
Other
- Pregnancy or lactation;
- Participation in another clinical trial within the last 3 months;
- TC genotype (excluded).
Who the study is looking for
- 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)
Age in the registry: 30 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Center for New Medical Technologies Coordinator of this site? Confirm its status | Novosibirsk | Russia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.