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RecruitingTherapeutic use (Phase IV)Interventional

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

Managing type 2 diabetes can involve trial and error to find the right medicine. This study tests a new approach called pharmacogenetic-guided treatment. This means doctors use information from your genes to predict which medicine is most likely to suit your body. Participants are split into two groups. One group has their diabetes medicine chosen using their genetic results. The other group receives standard care, where doctors choose medicines in the usual way. Both groups will use well-known, approved diabetes treatments, such as tablets or injections like metformin, Ozempic, or Jardiance. The trial lasts 24 weeks. Researchers want to see if using gene tests helps more people reach a healthy blood sugar target (an HbA1c level of 7% or lower). They will also look at blood pressure, cholesterol levels, and any side effects.

At a glance

Status
Recruiting
Phase
Therapeutic use (Phase IV)
Sponsor
Instituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA
Enrolment target
504
Start
28 Apr 2025
Type 2 Diabetes Mellitus

What is this study about?

Type 2 diabetes is a common condition where the body struggles to keep blood sugar levels in a healthy range. There are many different medicines available to treat it, from everyday tablets to weekly injections. However, because everyone's body processes medicine differently, a treatment that works well for one person might cause side effects or fail to lower blood sugar in another.

This clinical trial explores whether personalising care using genetic testing can take the guesswork out of prescribing. Your genes act as an instruction manual for your body, influencing how quickly you break down and use different drugs. In this study, researchers want to find out if using a genetic test to match patients with the most suitable diabetes medication leads to better results than standard prescribing methods.

During the trial, doctors will compare two groups of patients over 24 weeks. One group will receive medicines chosen with the help of their genetic test results, while the other group will follow standard treatment guidelines. All the medicines used in the trial are already approved and widely prescribed for type 2 diabetes.

By comparing the two groups, researchers hope to see whether gene-guided treatment helps more people achieve healthy blood sugar levels, improves cholesterol and blood pressure, and reduces unwanted side effects. If successful, this research could help make diabetes care more personal and effective across the NHS.

Key takeaways

  • Tests whether genetic information helps doctors pick the best diabetes medicine for you.
  • Compares gene-guided prescribing against standard treatment choices over 24 weeks.
  • Uses approved diabetes medications that are already widely available.
  • Open to adults aged 18 and over with type 2 diabetes whose blood sugar is above target.
  • Involves regular check-ups, blood tests, and monitoring of blood pressure and cholesterol.

Who may be eligible?

This study is open to adults aged 18 and older who have been diagnosed with type 2 diabetes. Both men and women can take part.

To join the main comparison group, your blood sugar must currently be higher than recommended. Specifically, your HbA1c level (a test showing your average blood sugar over the past three months) should be above 7%. If your blood sugar is already at or below this target, you will not be placed into the main randomised study groups.

The study team will check your overall health, including your kidney and liver function, to ensure it is safe for you to take part and use the study medicines.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. I am aged 18 or older.
  2. I have been diagnosed with type 2 diabetes.
  3. My recent blood sugar levels (HbA1c) are above 7% (uncontrolled).
  4. I am able to attend clinic visits and blood tests over a 24-week period.
  5. I am willing to take prescribed diabetes tablets or injections.
Answer every question to see your result.

What does participation involve?

If you decide to join, you will first have a health check and give a blood sample for genetic testing. You will then be randomly placed into one of two groups: one where your genetic results guide your treatment choice, and one where your doctor selects your medicine using standard guidelines.

You will be prescribed approved diabetes medications. These may be daily tablets (such as metformin, sitagliptin, or Jardiance) or once-weekly injections (such as Ozempic or Trulicity), depending on what is right for you. You will follow this treatment plan for 24 weeks (about six months).

Throughout the study, you will attend regular clinic appointments. During these visits, doctors will measure your blood sugar, check your blood pressure and cholesterol, and run routine blood tests to monitor your kidney and liver health. You will also be asked about any side effects or changes in how you feel.

Potential risks and benefits

Taking part may help you achieve better control of your blood sugar, and you will receive regular health checks and close medical supervision. However, there is no guarantee that your treatment will work better than standard care. You may experience known side effects from the diabetes medicines, such as an upset stomach, nausea, or low blood sugar. Having blood samples taken may also cause brief discomfort or mild bruising. Joining the study is completely voluntary, and you are free to leave at any time without your regular NHS medical care being affected.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • —
    Unverified
    Spain

Common questions

What is pharmacogenetic testing?

It is a simple test that looks at specific genes in your DNA to see how your body processes and reacts to different medicines.

Are the medications in this study brand new or untested?

No. All the medicines used in this study are already approved, thoroughly tested, and commonly prescribed for type 2 diabetes.

What is HbA1c?

HbA1c is a routine blood test that shows your average blood sugar levels over the past two to three months. A level of 7% (53 mmol/mol) or below is a common target.

Will I have to pay to take part in this study?

No. Clinical trials are free to join, and all study-related tests and medications are provided at no cost to you.

What happens if I change my mind after starting?

You can leave the trial at any point. Your decision will not change the quality of your regular NHS care or your relationship with your doctor.

How to find out more

Official trial record

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Open-label, double-arm, controlled, randomized, multicentre …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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