NCT06911983

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 4, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

April 20, 2025

Status Verified

March 1, 2025

Enrollment Period

5 months

First QC Date

March 28, 2025

Last Update Submit

April 17, 2025

Conditions

Diabetes Mellitis

Keywords

geneticspolymorphysmsupplementsberberine

Outcome Measures

Primary Outcomes (2)

  • Change in HbA1c

    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)

    12 weeks

Secondary Outcomes (10)

  • Fasting Plasma Glucose change (FPG)

    12 weeks

  • Postprandial Glucose (PPG) change

    12 weeks

  • Serum Insulin Levels

    12 weeks

  • HOMA-IR change

    12 weeks

  • Body Weight in kg change

    12 weeks

  • +5 more secondary outcomes

Study Arms (2)

Metformin Group

ACTIVE COMPARATOR

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

Berberine Group

EXPERIMENTAL

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

Dietary Supplement: Berberine

Interventions

MetforminDRUG

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

Metformin Group
BerberineDIETARY_SUPPLEMENT

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

Berberine Group

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for New Medical Technologies

Novosibirsk, Russia

Location

MeSH Terms

Interventions

MetforminBerberine

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsBerberine AlkaloidsBenzylisoquinolinesAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-Ring

Central Study Contacts

Andrei V Ponomarenko

CONTACT

+79873198946ponomarenko_av@cnmr.ru

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2025

First Posted

April 4, 2025

Study Start

July 1, 2025

Primary Completion

December 1, 2025

Study Completion

March 1, 2026

Last Updated

April 20, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)