Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Randomized, double-blind, multicenter, parallel group, placebo-controlled study to evaluate the efficacy and safety of phenofibrate treatment on the functions of beta cells in children and adolescents with newly diagnosed of type 1 diabetes

This research study is investigating a medicine called phenofibrate for children and teenagers who have recently been diagnosed with type 1 diabetes. The main goal is to find out if this medicine can help 'beta cells' in the pancreas, which are responsible for making insulin, to work better or survive longer. In type 1 diabetes, these cells are attacked and destroyed, leading to the body not making enough insulin. By testing phenofibrate against a dummy pill (placebo), doctors hope to understand if it could be a new way to help manage the condition and slow down its progression from the start. They will also be looking closely at safety.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Medical University Of Warsaw

Enrolment target

Start

22 Sep 2024

Evaluation of the effect of phenofibrate on the functions of beta cells in children with new diagnosis of type 1 diabetes

What is this study about?

This research study is looking at a new way to help children and teenagers who have recently been told they have type 1 diabetes. When someone has type 1 diabetes, their body's immune system accidentally attacks and destroys special cells in the pancreas called 'beta cells'. These beta cells are super important because they produce insulin, a hormone that helps your body use sugar for energy. Without enough insulin, blood sugar levels rise too high.

The study aims to see if a medicine called phenofibrate can protect these beta cells and help them work better or for longer after diagnosis. Currently, people with type 1 diabetes need to take insulin injections for life. If we can find treatments that protect the beta cells, it could potentially mean that people produce some of their own insulin for longer, which might make managing their diabetes easier.

In this study, some participants will receive the active medicine (phenofibrate), while others will receive a 'placebo' – which looks exactly like the medicine but contains no active ingredients. This helps researchers compare the effects fairly. They will be carefully checking how well the beta cells are working, as well as looking at blood sugar control and the safety of the medicine.

Key takeaways

Targets newly diagnosed children and teenagers with type 1 diabetes.
Investigating a medicine called phenofibrate to protect insulin-producing 'beta cells'.
Compares the active medicine to a dummy pill (placebo).
Focuses on improving beta cell function and overall diabetes control.
Safety of the medicine will be carefully watched.
Aims to find new ways to manage type 1 diabetes from an early stage.

Who may be eligible?

This study is open to all children and teenagers who have recently been diagnosed with type 1 diabetes. Both boys and girls can take part.

There might be other specific health requirements for joining, such as how long it’s been since your diagnosis, or if you have any other health conditions. These specific details would be discussed with you and your family by the study doctor to make sure the study is a good fit.

It’s important that participants are able to attend regular appointments and follow the study instructions carefully.

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.

Are you a child or teenager?
Have you been newly diagnosed with type 1 diabetes?
Are you able to take medication in tablet form?
Can you attend regular hospital or clinic appointments?
Are you interested in contributing to diabetes research?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either the study medicine (phenofibrate) or a dummy pill (placebo) in tablet form. You wouldn't know which one you're taking, nor would the doctors treating you, to ensure the results are unbiased. You would have several visits to the clinic over time, where doctors would perform tests to see how your beta cells are working. This involves a special blood test called a 'C-peptide stimulation test' at the start and at different points during the study. They would also monitor your blood sugar control through regular blood tests like HbA1c, take measurements of your daily insulin use, and check for any inflammation markers. The study will also carefully track your health and any side effects to make sure the medicine is safe. The total duration of your participation would be explained fully by the study team.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as receiving close medical attention and access to a new treatment that might help some individuals, though it's important to remember that new treatments don't always work as expected. On the other hand, there are potential risks, like experiencing side effects from the study medicine, or the medicine might not be effective for you. You will be closely monitored by the study team for any health changes. Remember, you can choose to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

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Unverified
Poland

Common questions

What are 'beta cells' and why are they important?

Beta cells are special cells in your pancreas that make insulin, which helps your body use sugar for energy. In type 1 diabetes, they are destroyed.

What is phenofibrate?

Phenofibrate is a medicine that researchers are testing to see if it can help protect or improve the function of beta cells in people with new type 1 diabetes.

What is a 'placebo'?

A placebo is a dummy pill that looks exactly like the study medicine but doesn't contain any active ingredients. It's used for comparison.

Will I know if I'm getting the real medicine or the placebo?

Neither you nor your doctors will know if you're receiving the active medicine or the placebo during the study. This helps keep the results fair.

What is a 'C-peptide stimulation test'?

This is a special blood test that measures how much insulin your body makes on its own, which helps doctors understand how well your beta cells are working.