Interleukin-2 Therapy of Autoimmunity in Diabetes
Research type
Research Study
Full title
Interleukin-2 therapy of Autoimmunity in Diabetes: ITAD
IRAS ID
230456
Contact name
Trial Address
Contact email
Sponsor organisation
University of Oxford
Eudract number
2017-002126-20
Duration of Study in the UK
2 years, 4 months, 30 days
Research summary
Type 1 diabetes is a common autoimmune disorder caused by the immune system mistakenly reacting to the insulin-producing cells (beta cells) in the pancreas, which eventually leads to the destruction of pancreatic β cells and deficiency of insulin secretion, requiring lifelong insulin injections
Insulin is still the only prescribed drug for T1D and unfortunately exogenous insulin replacement does not always provide the metabolic regulation necessary to avoid short- and long-term complications.
We now know that most newly-diagnosed cases still have sufficient insulin production to prevent the complications of diabetes. If this residual insulin secretion could be preserved, then many of these life-threatening complications could be avoided and exogeneous insulin requirements lowered.
There are substantial data to suggest IL-2 (aldesleukin) therapy can arrest the autoimmune-mediated destruction of pancreatic β cells. However, there is a lack of data in newly diagnosed children and adolescents with T1D, leading to the need of a specific assessment of ultra-low dose aldesleukin in this age group.
In this trial, we will treat with aldesleukin or placebo twice-weekly for 6 months so that we can assess long-term safety and tolerability in children and adolescents with T1D, through the study of the effects on both the immune system and β-cell function by measuring C-peptide frequently and other metabolic parameters.
We will be recruiting 45 newly-diagnosed (within 6 weeks of diagnosis), children and young adults with T1D, between the ages of 6 and 18, who still have detectable C-peptide levels that indicate residual β-cell function and in whom we can measure any changes in this C-peptide production over the proposed 12-month period of the trial.
Patients will be on study for approximately 13 months, this includes 1 month for screening, 6 months of trial treatment and 6 months follow-up. During this time, patients will be asked to visit hospital 7 times for study visits. Visits consist of a blood draw, height, weight and BMI, vital signs an AE review and concomitant medications review.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
18/SC/0358
Date of REC Opinion
30 Jul 2018
REC opinion
Further Information Favourable Opinion