Impact of Pharmacogenetic-Guided Treatment on Type 2 Diabetes. (NCT06851962) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Impact of Pharmacogenetic-Guided Treatment on Type 2 Diabetes.
Spain504 participantsStarted 2025-05-26
Plain-language summary
The goal of this clinical trial is to assess the efficacy of a pharmacogenetics-guided treatment, compared to standard optimized treatment, in patients with inadequately controlled type 2 diabetes. The main questions it aims to answer are:
* Is the disease better controlled when the treatment prescribed is based on the participant's pharmacogenetic profile?
* What medical problems do participants experience while taking the treatment?
Participants will:
* Take the treatment described according to the Summary of Product Characteristics (SmPC).
* Visit the clinic once every 12 weeks for checkups and tests.
* Keep a diary of their symptoms to inform the Investigator.
Who can participate
Age range40 Years – 70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age 40-70 years old, included.
✓. Body Mass Index (BMI) between 25-40 kg/m².
✓. Diagnosis of Type 2 Diabetes (T2D) according to the American Diabetes Association (ADA) criteria.
✓. Patients with T2D insufficiently controlled (Hemoglobin A1c (HbA1c) 7-9.5%) with current (≥6 months) "standard of care" treatment, excluding the use of insulin.
✓. The subject has provided written informed consent prior to any study-specific procedure.
✓. Able and willing to comply with requested study visits and procedures.
✓. Contraceptive measures, only for female participants:
Exclusion criteria
✕. Treatment with insulin at the time of screening.
✕. HbA1c \>9.5% at screening.
✕. Treatment with more than 3 glucose-lowering drugs at the time of screening.
What they're measuring
1
Comparison of HbA1c ≤7% goal at Week 24 between Pharmacogenetic-Guided and Standard Treatment in Type 2 Diabetes
Timeframe: From baseline to the end of treatment at 24 weeks
Trial details
NCT IDNCT06851962
SponsorFundación para la Investigación del Hospital ClÃnico de Valencia
✕. Chronic renal disease defined as estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m² (many glucose-lowering drugs are not approved or require dosage adjustments for use in these patients) at the screening visit.
✕. Hepatic insufficiency, which contraindicates the use of glucose-lowering drugs.
✕. Currently receiving treatment in another investigational drug study, or less than 30 days since ending treatment in another investigational drug study.
✕. Pregnancy or lactation.
✕. Women of childbearing potential with no effective contraceptive methods.