Comparative Efficacy of Metformin and Berberine Among TCF7L2 (rs7903146) TT vs. CC Genotype Carriers With Type 2 Diabetes

S.LAB (SOLOWAYS)

Status: Not yet enrolling

Conditions: Diabetes Mellitis

Treatments: Drug: Metformin; Dietary Supplement: Berberine

Study type: Interventional

Funder types: Other

Identifiers

NCT06911983

SW026

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Metformin Group

Active Comparator group

Description:

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

Treatment:

Drug: Metformin

Berberine Group

Experimental group

Description:

* Dose: 500 mg three times daily (1,500 mg/day total) * Formulation: standardized berberine HCl tablets * Duration: 12 weeks

Treatment:

Dietary Supplement: Berberine