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 range
40 Years – 70 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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 Clínico de Valencia
. 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.
. 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.