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

StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record status
This record was last updated April 20, 2025 (before its estimated December 1, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Eligibility criteria revisedv3
  2. Eligibility criteria shortened, about 11 wordsv2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
S.LAB (SOLOWAYS)
8 trials monitored
See all monitored trials
Diabetes
5,087 trials monitored
See 222 trials at risk
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 Details
NCT Number NCT06911983
Lead Sponsor S.LAB (SOLOWAYS)
Collaborators: Center for New Medical Technologies, Novosibirsk, Russia
Conditions
(from sponsor)		 Diabetes Mellitis
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov