Can a drug save Insulin-Making cells in kids with New-Onset diabetes?
NCT ID NCT03782636
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.
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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
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Jan 2019
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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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
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6 to 18 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Bristol Royal Hospital for Children
Bristol, United Kingdom
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Nottingham Children's Hospital
Nottingham, United Kingdom
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Oxford Children's Hospital
Oxford, Oxfordshire, OX3 9DU, United Kingdom
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The Great North Children's Hospital
Newcastle upon Tyne, United Kingdom
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