Active not recruitingPHASE2INTERVENTIONAL

Interleukin-2 Therapy of Autoimmunity in Diabetes (ITAD)

If you or someone you know has been recently diagnosed with Type 1 diabetes, you might be interested in a research study called Interleukin-2 Therapy of Autoimmunity in Diabetes (ITAD). The main goal of this study is to see if a drug called aldesleukin can help people recently diagnosed with Type 1 diabetes continue to produce their own insulin. This is important because the longer someone with Type 1 diabetes makes their own insulin, the better it is for controlling their blood sugar and avoiding long-term health problems. Researchers believe that aldesleukin might help rebalance the body's immune system, which mistakenly attacks the cells that make insulin. Participants will either receive the study drug or a placebo (a dummy treatment) to compare their effects. This study is for children and young adults aged 6-18 who were diagnosed with Type 1 diabetes within the last six weeks.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

University of Oxford

Enrolment target

Start

28 Jan 2019

Estimated completion

01 Sep 2026

Type1 Diabetes

What is this study about?

When someone gets Type 1 diabetes, their body's own defense system, called the immune system, starts attacking and destroying the cells in the pancreas that produce insulin. Insulin is a hormone that helps the body use sugar for energy. Without enough insulin, blood sugar levels become too high, which can lead to serious health problems. At the time of diagnosis, there are usually still some of these insulin-producing cells left, and they're still making a small amount of insulin. This ability to make some insulin is really helpful for managing the condition.

Over time, most people with Type 1 diabetes stop making their own insulin completely. This can happen quite quickly for some, or more slowly over a few years for others. If we could find ways to protect these remaining insulin-producing cells and help them keep working for longer, it could make a big difference. It would make it easier to control blood sugar levels and potentially reduce the risk of future health complications.

This study is trying to do just that. We're looking at a drug called aldesleukin because we think it might help by rebalancing the immune system. In Type 1 diabetes, the immune system gets a bit out of whack. Aldesleukin is a version of a natural protein (called Interleukin-2) that our bodies already make, and it might help to restore that balance. It's thought that starting this kind of treatment soon after diagnosis is crucial because that's when there's the best chance of saving those remaining insulin-producing cells.

Key takeaways

This study is for children and young adults (6-18) with newly diagnosed Type 1 diabetes.
It aims to see if a drug called aldesleukin can help preserve natural insulin production.
Preserving insulin production can make it easier to manage diabetes.
Participants will receive either the study drug or a placebo.
The study involves regular clinic visits, blood tests, and injections.

Who may be eligible?

To join this study, participants need to be between 6 and 18 years old and have been diagnosed with Type 1 diabetes within the last six weeks. They must also still be making some of their own insulin, which doctors can check with a simple blood test. It's important that they don't have other types of diabetes, like Type 2, or other serious health conditions like certain heart problems, severe kidney disease, or currently active infections. If a participant has other autoimmune diseases (apart from Type 1 diabetes) or certain cancers, they wouldn't be able to join.

We also can't include people who are taking certain medications that affect the immune system or could be harmful to the liver, kidneys, or heart. For female participants, they cannot be pregnant, breastfeeding, or planning to become pregnant during the study. If they are able to have children, they must agree to use effective contraception and have regular pregnancy tests. Male participants must also agree to use contraception if they are sexually active.

Finally, participants shouldn't have taken part in another clinical trial recently (within the last four months) or have any other medical issue that the study doctor thinks would make it unsafe for them to participate.

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 between 6 and 18 years old?
Were you diagnosed with Type 1 diabetes in the last 6 weeks?
Do you not have other serious health conditions like certain heart or kidney problems?
Are you not currently pregnant or breastfeeding, and if able to have children, willing to use contraception?
Are you not taking certain medications that affect the immune system?
Have you not recently participated in another clinical trial?

Answer every question to see your result.

What does participation involve?

If you join this study, it will involve several visits to the clinic over a period of time. You will receive either the study drug, aldesleukin, or a placebo (a treatment that looks the same but contains no active medicine). The medication will be given as injections. Throughout the study, you'll have regular check-ups, blood tests, and other assessments to monitor your health and see how your body is responding. The total duration of your participation in the study will be explained in detail by the study team, along with all the procedures and what to expect at each visit. The team will be there to answer any questions you have.

Potential risks and benefits

Taking part in this study may offer some potential benefits, such as helping to preserve your body's own insulin production for longer, which could improve your diabetes management. However, there's no guarantee that you will personally benefit from taking part. As with any medication, aldesleukin may have side effects, and some people might experience discomfort from injections or blood tests. The study team will carefully monitor your health throughout. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (5)

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

Oxford Children's Hospital
Verified postcode
Oxford, United Kingdom
Bristol Royal Hospital for Children
Verified postcode
Bristol, United Kingdom
Addenbrooke's Hospital
Verified postcode
Cambridge, United Kingdom
The Great North Children's Hospital
Verified postcode
Newcastle upon Tyne, United Kingdom
Nottingham Children's Hospital
Verified postcode
Nottingham, United Kingdom

Common questions

What is Type 1 diabetes?

Type 1 diabetes is a health condition where your body's immune system mistakenly attacks and destroys the cells in your pancreas that make insulin, a hormone needed to control blood sugar.

What is aldesleukin?

Aldesleukin is a medicine being tested in this study. It's a version of a natural protein your body already makes, and it's thought to help rebalance your immune system.

What is a placebo?

A placebo is a treatment that looks just like the study drug but contains no active medicine. It helps researchers compare the effects of the active drug.

Will I know if I'm getting the drug or the placebo?

No, you won't know whether you are receiving aldesleukin or the placebo during the study. This is common in clinical trials to ensure fair and unbiased results.

How long will the study last?

The full duration of the study for each participant will be explained by the study team. It involves several clinic visits and regular check-ups.