NCT06851962CompletedPhase 4
Impact of Pharmacogenetic-Guided Treatment on Type 2 Diabetes.
Open-label, Double-arm, Controlled, Randomized, Multicentre Clinical Trial to Evaluate the Impact of Pharmacogenetic-guided Treatment in Patients With Insufficiently Controlled Type 2 Diabetes.
Source: ClinicalTrials.gov · Last updated 4 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 92 (actual)
- First submitted
- 30 Jan 2025
- Start date
- 26 May 2025
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
- Diseases
- Type 2 diabetes
- NCT number
- NCT06851962
- EU CT number
- 2025-520686-46-00
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 92
- From 26 May 2025 to the primary completion date, 30 Jun 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with insulin at the time of screening.
- Currently receiving treatment in another investigational drug study, or less than 30 days since ending treatment in another investigational drug study.
Other illness
- New York Heart Association (NYHA) Class III or IV congestive heart failure.
Lab values
- 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.
Age
- Life expectancy predicted to be \<2 years.
Other
- Pregnancy or lactation.
- Women of childbearing potential with no effective contraceptive methods.
- 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.
- Subject is study staff directly involved with the study or is a family member of the investigational study staff.
Who the study is looking for
- 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:
- 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.
Age in the registry: 40 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Regional Universitario de Malaga Coordinator of this site? Confirm its status | Málaga | Spain | Completed |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Completed |
| Hospital General Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.