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

April 17, 2025 updated by: S.LAB (SOLOWAYS)

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
Drug: 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
Experimental: Berberine Group
  • Dose: 500 mg three times daily (1,500 mg/day total)
  • Formulation: standardized berberine HCl tablets
  • Duration: 12 weeks
Dietary supplement: Berberine

Berberine

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Fasting Plasma Glucose change (FPG)
Time Frame: 12 weeks
12 weeks
Postprandial Glucose (PPG) change
Time Frame: 12 weeks
12 weeks
Serum Insulin Levels
Time Frame: 12 weeks
12 weeks
HOMA-IR change
Time Frame: 12 weeks
12 weeks
Body Weight in kg change
Time Frame: 12 weeks
12 weeks
Total Cholesterol change
Time Frame: 12 weeks
12 weeks
Triglycerides change
Time Frame: 12 weeks
12 weeks
LDL-C change
Time Frame: 12 weeks
12 weeks
HDL-C change
Time Frame: 12 weeks
12 weeks
Number of any adverce events
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

S.LAB (SOLOWAYS)

Collaborators

Center for New Medical Technologies, Novosibirsk, Russia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2025

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

March 28, 2025

First Submitted That Met QC Criteria

March 28, 2025

First Posted (Actual)

April 4, 2025

Study Record Updates

Last Update Posted (Actual)

April 20, 2025

Last Update Submitted That Met QC Criteria

April 17, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SW026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe