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Can a drug save Insulin-Making cells in kids with New-Onset diabetes?

NCT ID NCT03782636

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial is testing whether aldesleukin, a drug that helps regulate the immune system, can preserve insulin production in children and young adults (ages 6-18) recently diagnosed with type 1 diabetes. Participants receive either aldesleukin or a placebo for 6 months, and researchers measure changes in C-peptide levels (a marker of insulin production). The goal is to see if the drug can slow the loss of natural insulin-making ability.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Aldesleukin (a lab-made version of interleukin-2, a protein that helps regulate the immune system)
What this could lead to
If it works, this could point toward a way to preserve natural insulin production in people newly diagnosed with type 1 diabetes, potentially reducing their long-term reliance on insulin injections.
What could go wrong
This is a small, early-phase trial with only 41 participants, so results may not apply to everyone. Aldesleukin can cause flu-like symptoms and skin reactions, and it is unclear if it will meaningfully preserve insulin production over time.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

41 people

The number who actually took part.

Started

Jan 2019

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Have given written informed consent to participate or assent with parental consent 2. Be aged 6-18 years 3. Be diagnosed with T1D (Type 1 Diabetes) (at least one autoantibody positive), requiring insulin treatment 4. Be within 6 weeks from diagnosis of T1D (at screening) 5. Have a random C-peptide \> 200 pmol/l 6. Normal full blood count Exclusion Criteria: 1. Non-type 1 diabetes (type 2 or monogenic diabetes) and secondary diabetes 2. Pre-existing autoimmune disease (excluding type 1 diabetes) 3. Hypersensitivity to aldesleukin or any of the excipients 4. History of severe cardiac disease (NYHA Class III or IV) 5. History of malignancy within the past 5 years (with the exception of adequately treated basal or squamous cell carcinoma or cervical carcinoma in situ) 6. Clinically significant abnormal laboratory values (out of range and associated with clinical symptoms or signs) in haematology, biochemistry, thyroid, liver and kidney function 7. Pre-existing severe major organ dysfunction or seizure disorders 8. Participation in another clinical trial (CTIMP) within 4 months prior to screening 9. Females who are pregnant, lactating or intend to get pregnant during the study 10. Females of childbearing potential who are unwilling or unable to comply with contraceptive advice and regular pregnancy testing throughout the trial 11. Sexually active males who are unwilling or unable to comply with contraceptive advice 12. Current use of immunosuppressive agents or steroids 13. Current treatment with hepatotoxic, nephrotoxic, myelotoxic, or cardiotoxic products 14. Active clinical infections - participants can be recruited after a minimum period of 48 h after last day of feeling unwell or last day of antibiotic/anti-viral treatment 15. Any medical history or clinically relevant abnormality that is deemed by the principal investigator and/or medical monitor to make the participant ineligible for inclusion because of a safety concern 16. Children with compliance problems (families where the local investigators consider that problems with compliance may be an issue)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Addenbrooke's Hospital

    Cambridge, United Kingdom

  • Bristol Royal Hospital for Children

    Bristol, United Kingdom

  • Nottingham Children's Hospital

    Nottingham, United Kingdom

  • Oxford Children's Hospital

    Oxford, Oxfordshire, OX3 9DU, United Kingdom

  • The Great North Children's Hospital

    Newcastle upon Tyne, United Kingdom

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