Interleukin-2 Therapy of Autoimmunity in Diabetes (ITAD)

Launched by UNIVERSITY OF OXFORD · Dec 19, 2018

Keywords

ClinConnect Summary

Investigators know that the longer people with diabetes can produce their own insulin, the better it is for the control of their blood glucose levels and long-term complications.

People get type 1 diabetes because their immune system, the part of the body, which helps fight infections, mistakenly attacks and destroys the beta cells in the pancreas that produce insulin. As the immune system destroys these insulin-producing cells, the body's own ability to produce insulin decreases and diabetes develops.

At diagnosis, there are usually a small number of beta cells (10-20%) left in the pancr...

Gender

ALL

Eligibility criteria

• 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)