Comparative Efficacy of Metformin and Berberine Among TCF7L2 (rs7903146) TT vs. CC Genotype Carriers With Type 2 Diabetes
Launched by S.LAB (SOLOWAYS) · Mar 28, 2025
Trial Information
Current as of June 09, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at two treatments, metformin and berberine, to see which one works better for controlling blood sugar in people with newly diagnosed type 2 diabetes. The study focuses on individuals based on their genetic makeup, specifically those with the TCF7L2 gene variations (TT or CC). The main goal is to compare how these treatments affect blood sugar levels over 12 weeks. Researchers believe that berberine may work better for people with the TT genotype, while both treatments might be equally effective for those with the CC genotype.
To participate in this study, you need to be an adult aged 30 to 65, diagnosed with type 2 diabetes within the last year, and have certain blood sugar levels. You should not have taken diabetes medications before or for at least four weeks. Participants will undergo a genetic test to determine their TCF7L2 genotype and will receive either metformin or berberine during the trial. As this is a pilot study, it’s a chance to help researchers understand how to tailor diabetes treatments in the future.
Gender
ALL
Eligibility criteria
- 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).
About S.Lab (Soloways)
s.lab (soloways) is a pioneering clinical trial sponsor dedicated to advancing medical research through innovative study designs and robust methodologies. With a focus on enhancing patient outcomes, s.lab (soloways) collaborates closely with healthcare professionals, regulatory bodies, and trial participants to ensure the highest standards of ethical conduct and scientific integrity. Leveraging cutting-edge technology and data analytics, the organization aims to streamline the clinical trial process, facilitating the rapid development of effective therapies across various therapeutic areas. Committed to transparency and excellence, s.lab (soloways) is at the forefront of transforming clinical research into tangible health solutions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Novosibirsk, , Russian Federation
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported