Diabetes MellitisNCT06911983
Comparative Efficacy of Metformin and Berberine Among TCF7L2 (rs7903146) TT vs. CC Genotype Carriers With Type 2 Diabetes
A study testing Metformin and Berberine in people with Diabetes Mellitis, run by S.LAB (SOLOWAYS) at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Diabetes Mellitis
- What is being tested?
- Metformin and Berberine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jul 2025to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site
Center for New Medical Technologies
Novosibirsk
Andrei V Ponomarenko, ++9873198946, ponomarenko_av@cnmt.ru
About this study
Official title: 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.
- Conditions
- Diabetes Mellitis
- Being tested
- Metformin, Berberine
- Keywords
- genetics, polymorphysm, supplements, berberine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
BerberineDietary supplement
Berberine
- Dose: 500 mg three times daily (1,500 mg/day total)
- Formulation: standardized berberine HCl tablets
- Duration: 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Metformin |
| Berberine Group | Experimental | * Dose: 500 mg three times daily (1,500 mg/day total)
* Formulation: standardized berberine HCl tablets
* Duration: 12 weeks Receives: Dietary Supplement: Berberine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
Change in HbA1c from baseline to Week 12 in each genotype group (TT or CC), comparing: TT + Berberine vs. TT + Metformin
Measured: 12 weeks
Change in HbA1c from baseline (CC + Berberine vs. CC + Metformin)
Measured: 12 weeks
Secondary outcomes (10)
Fasting Plasma Glucose change (FPG)
Measured: 12 weeks
Postprandial Glucose (PPG) change
Measured: 12 weeks
Serum Insulin Levels
Measured: 12 weeks
HOMA-IR change
Measured: 12 weeks
Body Weight in kg change
Measured: 12 weeks
Total Cholesterol change
Measured: 12 weeks
Triglycerides change
Measured: 12 weeks
LDL-C change
Measured: 12 weeks
HDL-C change
Measured: 12 weeks
Number of any adverce events
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- S.LAB (SOLOWAYS)
- Sponsor type
- University, hospital or other
- Collaborators
- Center for New Medical Technologies, Novosibirsk, Russia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06911983
- Sponsor's protocol ID
- SW026
- Status last verified
- Mar 2025
- First submitted
- 28 Mar 2025
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Metformin and Berberine Among TCF7L2 (rs7903146) TT vs. CC Genotype Carriers With Type 2 Diabetes: A Pilot Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT06911983
- Acronym / sponsor ID
- SW026
- Conditions
- Diabetes Mellitis
- Keywords
- genetics, polymorphysm, supplements, berberine
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- S.LAB (SOLOWAYS)University, hospital or other
- Collaborators
- Center for New Medical Technologies, Novosibirsk, Russia
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 4 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin Group | Active comparator | Drug: MetforminInitial 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 Group | Experimental | Dietary Supplement: Berberine* Dose: 500 mg three times daily (1,500 mg/day total) * Formulation: standardized berberine HCl tablets * Duration: 12 weeks |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminMetformin • 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 Group |
| BerberineBerberine * Dose: 500 mg three times daily (1,500 mg/day total) * Formulation: standardized berberine HCl tablets * Duration: 12 weeks | Dietary supplement | Berberine Group |
Primary outcome
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
Change in HbA1c from baseline (CC + Berberine vs. CC + Metformin)
Time frame: 12 weeks
10 secondary outcomes
Fasting Plasma Glucose change (FPG)
Time frame: 12 weeks
Postprandial Glucose (PPG) change
Time frame: 12 weeks
Serum Insulin Levels
Time frame: 12 weeks
HOMA-IR change
Time frame: 12 weeks
Body Weight in kg change
Time frame: 12 weeks
Total Cholesterol change
Time frame: 12 weeks
Triglycerides change
Time frame: 12 weeks
LDL-C change
Time frame: 12 weeks
HDL-C change
Time frame: 12 weeks
Number of any adverce events
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metformin and Berberine in people with Diabetes Mellitis, run by S.LAB (SOLOWAYS) at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrei V Ponomarenko (+79873198946, ponomarenko_av@cnmr.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2025.