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.
Trial tests if genetic guidance improves type 2 diabetes control
Plain English Summary
Impact of Pharmacogenetic-Guided Treatment on Type 2 Diabetes. is a Phase 4 clinical trial sponsored by Fundación para la Investigación del Hospital Clínico de Valencia studying Diabetes Mellitus Type 2. This trial tests if tailoring diabetes medication based on a patient's genes leads to better blood sugar control compared to standard treatment. It is for adults aged 40-70 with type 2 diabetes that is not well-controlled by current medications (excluding insulin). Participants will receive either genetically guided treatment or standard optimized treatment and attend clinic visits every 12 weeks. Alternatives include continuing current treatment or discussing other medication options with a doctor. The trial aims to enroll 504 participants.
Official 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
Here is what you need to know about eligibility for this trial. You can join if you are between 40 and 70 years old, have type 2 diabetes, and your blood sugar (HbA1c) is between 7% and 9.5% despite taking at least 3 medications for 6 months (but not insulin). You cannot join if you use insulin, have very high blood sugar (HbA1c >9.5%), have severe kidney or liver problems, are pregnant or breastfeeding, or are participating in another drug trial. A Body Mass Index (BMI) between 25-40 kg/m² is required. Women of childbearing potential must agree to use effective contraception. This trial is studying Diabetes Mellitus Type 2, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures whether patients reach a target blood sugar level (HbA1c below 7%) after 24 weeks, indicating better disease control. The specific primary outcome measures are: Comparison of HbA1c ≤7% goal at Week 24 between Pharmacogenetic-Guided and Standard Treatment in Type 2 Diabetes (From baseline to the end of treatment at 24 weeks). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This is a Phase 4 (post-marketing) study of a treatment that has already received FDA approval. Phase 4 trials monitor long-term safety, effectiveness in broader patient populations, and potential interactions with other treatments in real-world settings. These studies can involve thousands of patients and help identify rare side effects that may not have appeared in earlier, smaller trials.
Why This Trial Matters
This trial matters because it explores a personalized approach to managing type 2 diabetes, aiming to fill the gap in treatments that are not effective for everyone. This research targets Diabetes Mellitus Type 2, where improved treatment options are needed.
Investor Insight
This trial signals a growing interest in precision medicine for diabetes, a large market, with potential for improved treatment efficacy and patient outcomes. This treatment is already approved and on the market. This post-marketing study monitors real-world outcomes. The large enrollment target of 504 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor if your current diabetes treatment is optimized and if genetic testing might be beneficial for you. Participation involves regular clinic visits for check-ups and tests, and you'll need to track your symptoms. Be prepared for potential changes in your medication regimen based on genetic results. The trial is being conducted at 3 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: SINGLE
- Enrollment: 504 participants
Interventions
- DRUG: Metformin — Metformin maximum daily dose 2000 mg
- DRUG: Dulaglutide — Dulaglutide
- DRUG: Semaglutide 1.0 mg — Semaglutide
- DRUG: Empagliflozin (BI 10773) — Empagliflozin
- DRUG: Canagliflozin — Canagliflozin
Primary Outcomes
- Comparison of HbA1c ≤7% goal at Week 24 between Pharmacogenetic-Guided and Standard Treatment in Type 2 Diabetes (From baseline to the end of treatment at 24 weeks)
Secondary Outcomes
- Comparison of Pharmacogenetic Markers and Treatment Response Pre-Randomization (Before randomization to the end of treatment at 24 weeks)
Full 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.
Trial Locations
- Hospital Universitario Regional de Málaga, Málaga, Spain
- Hospital Clínico Universitario de Valencia, Valencia, Spain
- Hospital General Universitario de Valencia (HGUV), Valencia, Spain
Frequently Asked Questions
What is clinical trial NCT06851962?
NCT06851962 is a Phase 4 INTERVENTIONAL study titled "Impact of Pharmacogenetic-Guided Treatment on Type 2 Diabetes.." It is currently active, not recruiting and is sponsored by Fundación para la Investigación del Hospital Clínico de Valencia. The trial targets enrollment of 504 participants.
What conditions does NCT06851962 study?
This trial investigates treatments for Diabetes Mellitus Type 2. The primary condition under study is Diabetes Mellitus Type 2.
What treatments are being tested in NCT06851962?
The interventions being studied include: Metformin (DRUG), Dulaglutide (DRUG), Semaglutide 1.0 mg (DRUG), Empagliflozin (BI 10773) (DRUG), Canagliflozin (DRUG). Metformin maximum daily dose 2000 mg
What does Phase 4 mean for NCT06851962?
Phase 4 trials occur after a treatment is already approved and on the market. They monitor long-term effectiveness and safety in larger populations under real-world conditions.
What is the current status of NCT06851962?
This trial is currently "Active, Not Recruiting." It started on 2025-05-26. The estimated completion date is 2026-06-30.
Who is sponsoring NCT06851962?
NCT06851962 is sponsored by Fundación para la Investigación del Hospital Clínico de Valencia. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06851962?
The trial aims to enroll 504 participants. The trial status is active, not recruiting.
How is NCT06851962 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs single masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT06851962?
The primary outcome measures are: Comparison of HbA1c ≤7% goal at Week 24 between Pharmacogenetic-Guided and Standard Treatment in Type 2 Diabetes (From baseline to the end of treatment at 24 weeks). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06851962 being conducted?
This trial is being conducted at 3 sites, including Málaga; Valencia (Spain).
Where can I find official information about NCT06851962?
The official record for NCT06851962 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06851962. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06851962 testing in simple terms?
This trial tests if tailoring diabetes medication based on a patient's genes leads to better blood sugar control compared to standard treatment. It is for adults aged 40-70 with type 2 diabetes that is not well-controlled by current medications (excluding insulin).
Why is this trial significant?
This trial matters because it explores a personalized approach to managing type 2 diabetes, aiming to fill the gap in treatments that are not effective for everyone.
What are the potential risks of participating in NCT06851962?
Potential risks include side effects from diabetes medications, such as gastrointestinal issues or hypoglycemia (low blood sugar). The genetic guidance might lead to a change in medication that could have unforeseen effects. As with any trial, there's a risk that the treatment may not be more effective than your current one. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06851962?
Ask your doctor if your current diabetes treatment is optimized and if genetic testing might be beneficial for you. Participation involves regular clinic visits for check-ups and tests, and you'll need to track your symptoms. Be prepared for potential changes in your medication regimen based on genetic results. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06851962 signal from an investment perspective?
This trial signals a growing interest in precision medicine for diabetes, a large market, with potential for improved treatment efficacy and patient outcomes. This is a Phase 4 trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will receive either genetically guided treatment or standard optimized treatment and attend clinic visits every 12 weeks. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.