Center for New Medical Technologies
Novosibirsk, Russia
Not Yet Recruiting
NCT Number: NCT06911983
Comparative Efficacy of Metformin and Berberine Among TCF7L2 (rs7903146) TT vs. CC Genotype Carriers With Type 2 Diabetes
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.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
30 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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).
Treatment and study plan
metformin
DrugMetformin • 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 SupplementBerberine
- Dose: 500 mg three times daily (1,500 mg/day total)
- Formulation: standardized berberine HCl tablets
- Duration: 12 weeks
Primary outcomes
-
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
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
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
S.LAB (SOLOWAYS)
Other
Collaborators
- Center for New Medical Technologies, Novosibirsk, Russia
Registry information
Official study title
Comparative Efficacy of Metformin and Berberine Among TCF7L2 (rs7903146) TT vs. CC Genotype Carriers With Type 2 Diabetes: A Pilot Randomized Clinical Study
Important dates
- Study start
- 2025
- Primary completion
- 2025
- Study completion
- 2026
- First posted
- Apr 4, 2025
- Registry last updated
- Apr 20, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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