Impact of Pharmacogenetic-Guided Treatment on Type 2 Diabetes Clinical Trial

Launched by FUNDACIÓN PARA LA INVESTIGACIÓN DEL HOSPITAL CLÍNICO DE VALENCIA · Feb 21, 2025

Keywords

ClinConnect Summary

This clinical trial is designed to see if a treatment plan tailored to a person's genetic makeup can help better control type 2 diabetes compared to the usual treatment. Researchers want to find out if using this personalized approach leads to improved management of diabetes symptoms and to learn about any side effects patients might experience while on the treatment.

To participate, you need to be between 40 and 70 years old, have a body mass index (BMI) between 25 and 40, and be diagnosed with type 2 diabetes that is not well-controlled despite being on standard treatment for at least six months. Participants will visit the clinic every three months for checkups, receive specific medications, and keep a diary of their symptoms to share with the study team. It's important to note that the trial is not yet recruiting participants, so you will need to wait until it officially begins.

Gender

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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 \<1%, during the study intervention period (to be effective before starting the intervention).
• • A WOCBP must have a negative urine pregnancy test before the first administration of study intervention.
• Exclusion Criteria:
• • 1. Treatment with insulin at the time of screening.
• • 2. HbA1c \>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) \<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.
• • 5. Hepatic insufficiency, which contraindicates the use of glucose-lowering drugs.
• • 6. Currently receiving treatment in another investigational drug study, or less than 30 days since ending treatment in another investigational drug study.
• • 7. Pregnancy or lactation.
• • 8. Women of childbearing potential with no effective contraceptive methods.
• • 9. New York Heart Association (NYHA) Class III or IV congestive heart failure.
• • 10. Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and investigator's knowledge.
• • 11. Subject is study staff directly involved with the study or is a family member of the investigational study staff.
• • 12. Life expectancy predicted to be \<2 years.