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

ConditionDiabetes Mellitis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-65
SponsorS.LAB (SOLOWAYS)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Metformin

    Drug

    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

    Dietary supplement

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Metformin GroupActive comparator 1 intervention
Group B: Berberine GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in HbA1c

Change in HbA1c from baseline to Week 12 in each genotype group (TT or CC), comparing: TT + Berberine vs. TT + Metformin

Time frame
12 weeks
2

Change in HbA1c from baseline (CC + Berberine vs. CC + Metformin)

Time frame
12 weeks

Secondary outcomes

1

Fasting Plasma Glucose change (FPG)

Time frame
12 weeks
2

Postprandial Glucose (PPG) change

Time frame
12 weeks
3

Serum Insulin Levels

Time frame
12 weeks
4

HOMA-IR change

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

S.LAB (SOLOWAYS)

Lead sponsor

Center for New Medical Technologies, Novosibirsk, Russia

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: