Interleukin-2 Therapy of Autoimmunity in Diabetes (ITAD)

Open to Recruitment

Recruiting sites

  • Bristol
  • Nottingham

Summary 

ITAD is a multicentre, randomised, double-blind, placebo-controlled clinical trial of  to see if a drug called aldesleukin, can preserve insulin production in children and young adults recently diagnosed with type 1 diabetes.

We 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.

At diagnosis, there are usually a small number of beta cells (10-20%) left in the pancreas, which still produce small amounts of insulin.  We call this ‘beta cell function’ and we assess this by measuring C-peptide, which is made by the pancreas when insulin is produced.  Most people with type 1 diabetes eventually stop producing insulin themselves, this may occur rapidly in a few months, or more slowly over several years.

New treatments preserving insulin production could improve management of diabetes. This could be done by using drugs acting on cells of the immune system.  In type 1 diabetes, there is an imbalance between cells of the immune system, and there is evidence that one protein produced by our body, called Interleukin-2, could help in resetting the balance between those cells. It is important to start this treatment soon after diagnosis because this is when there is the best chance of saving the beta cells still left in the pancreas.

45 participants aged 6 to 18 will be recruited within 6 weeks of diagnosis of Type 1 Diabetes from a minimum of 6 UK sites and will be randomised 2:1 to either aldesleukin or placebo, as subcutaneous injection, twice a week for 6 months.  Participants will then be followed up for a further 6 months. Participants will have 7 study visits during their 12 months on the study.

Eligibility to take part

  1. Can give informed consent
  2. Aged 6 – 18 years
  3. Diagnosed with T1D (at least one autoantibody positive), requiring insulin treatment
  4. Within 6 weeks from diagnosis
  5. Have random C-peptide > 200 pmol/l
  6. Normal full blood count