About this trial
This prospective observational study will evaluate whether the SLC16A11 risk variant influences the response to metformin in adults with type 2 diabetes. Participants will be classified as carriers or noncarriers and followed for 6 months while receiving extended-release metformin titrated to the maximum tolerated dose, between 1,500 and 2,250 mg/day. The primary outcome is the change in glycated hemoglobin, with additional assessment of seven-point capillary glucose profiles, liver enzymes, visceral fat, lipid profile, and lactate concentrations. The study plans to include 154 participants to compare treatment response between both genetic groups and explore the potential value of a more personalized therapeutic approach.
Eligibility criteria
Qualifiers
Male and female participants
Aged 18 to 65 years
Diagnosis of type 2 diabetes
Estimated glomerular filtration rate (eGFR) >60 mL/min
Disqualifiers
Participants receiving treatment with three glucose-lowering medications
Participants receiving insulin therapy
Pregnancy
Breastfeeding
Trial design
Treatments tested in this trial
- Not listed