An interventional study of Metformin and Berberine in Diabetes Mellitis, sponsored by S.LAB (SOLOWAYS). Not yet recruiting at 1 site in Russian Federation. Open to participants aged 30 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-04-20.
Sponsored by S.LAB (SOLOWAYS) · Not applicable, Interventional, and Treatment
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.
S.LAB (SOLOWAYS) is the lead sponsor of 29 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
* Dose: 500 mg three times daily (1,500 mg/day total) * Formulation: standardized berberine HCl tablets * Duration: 12 weeks
Dietary Supplement: Berberine
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 * Dose: 500 mg three times daily (1,500 mg/day total) * Formulation: standardized berberine HCl tablets * Duration: 12 weeks
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
Change in HbA1c from baseline (CC + Berberine vs. CC + Metformin)
Time frame: 12 weeks
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
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Berberine
S.LAB (SOLOWAYS)