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Completed
NCT06851962
Impact of Pharmacogenetic-Guided Treatment on Type 2 Diabetes.
Conditions: Diabetes Mellitus Type 2
Sex: All
Ages: 40 Years – 70 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 92
Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia
Location: Hospital Universitario Regional de Málaga Málaga
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.
Eligibility Criteria
Inclusion Criteria:
1. Age 40-70 years old, included.
2. Body Mass Index (BMI) between 25-40 kg/m².
3. Diagnosis of Type 2 Diabetes (T2D) according to the American Diabetes Association (ADA) criteria.
4. Patients with T2D insufficiently controlled (Hemoglobin A1c (HbA1c) 7-9.5%) with current (≥6 months) "standard of care" treatment, excluding the use of insulin.
5. The subject has provided written informed consent prior to any study-specific procedure.
6. Able and willing to comply with requested study visits and procedures.
7. Contraceptive measures, only for female participants:
* A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:
* Is a woman of non-childbearing potential (WONCBP) OR
* Is a woman of childbearing potential (WOCBP) and agrees to use a contraceptive method that is highly effective, with a failure rate of \9.5% at screening.
3. Treatment with more than 3 glucose-lowering drugs at the time of screening.
4. Chronic renal disease defined as estimated glomerular filtration rate (eGFR) \
Source: ClinicalTrials.gov (NCT06851962). StuddyBuddy aggregates publicly available trial information.