A Phase 1/2 interventional study of Aldesleukin in Type 1 Diabetes, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2012-04-23.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 1/2, Interventional, and Treatment
IL-2 is an inducer of regulatory T cells (Treg), a population of lymphocytes that fail to control the autoimmune destruction of beta-cells in patients with Type 1 Diabetes (T1D). The investigators recently showed that low dose IL-2 is well tolerated in patients with an autoimmune disease. The investigators aim to use IL-2 to induce/stimulate Treg in T1D patients. This study will investigate the dose effect relationship of low dose IL-2 for Treg induction such as to optimize the risk benefit ratio for this treatment in T1D. By Treg induction, the investigators aim to protect the remaining/regenerating β-cells from autoimmune destruction, thus improving or even curing T1D.
Rationale:
Type 1 diabetes (T1D) results from an autoimmune destruction of beta-pancreatic cells that regulatory T cells (Treg) fail to control. This is in part due to a deficit in production of, or response to, interleukin 2 (IL-2). This cytokine is essential to Treg development, survival and function. Importantly, while IL-2 also contributes to the activation of effector T cells (Teff), IL-2/IL-2 receptor signal transduction threshold is much lower for Treg than Teff. Thus low-dose IL-2 could be a specific Treg inducer/stimulator.
The investigators then recently showed that low-dose IL-2 could cure recent onset diabetes in NOD mice that develop spontaneous diabetes considered as the best model of human T1D. A 5-day treatment with IL-2 could cure over 30% of the mice versus 0% for controls.
With these premises, the investigators propose to explore if Treg induction could be obtained in patients who may have a deficit in production of, or response to, IL-2. Defining the dose effect relationship of low dose IL-2 for Treg induction will optimize the risk benefit ratio for IL-2 in T1D.
Principal objective:
To define the dose-effect relationship of low dose IL-2 for Treg induction in patient with recent onset diabetes
Evaluation Criteria:
Study plan:
After inclusion (Day0), the patient receives a 5-day course of IL-2 or placebo. Patients are randomized in 4 arms receiving either a placebo, or IL-2 doses of 0,33 - 1 or 3 millions UI/day. Laboratory follow-up of peripheral blood T cell subsets will be performed at D0 to D6 (daily), D15, D22 and D60 by immunophenotyping and transcriptomics.
Tolerance will be evaluated at D0-6, D15, D22 and D60.
Methodology:
Double blind placebo controlled randomized study, with 4 parallel groups. Patients will have T1D of autoimmune origin attested by the presence of auto-antibodies (at least one of: anti-islet, anti-GAD, anti-IA2 or anti-ZnT8), with a diagnostic inferior or equal to 24 months.
Study length:
Study length = 9 months Patient participation = 2 months Inclusion period = 6 months
3,614 studies on the registry are indexed under Diabetes Mellitus, Type 1; 586 are open to participants now.
This study's enrollment of 25 is below the median of 40 across 2,718 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,576 studies on the registry; 1,028 are open to participants now.
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Exclusion Criteria:
Drug: Aldesleukin
1 millions IU of IL-2 per day
Drug: Aldesleukin
3 millions IU of IL-2 per day
Drug: Aldesleukin
0.33 millions IU of IL-2 per day
Drug: Aldesleukin
0.33 ; 1 ; 3 ; 0 millions IU of IL-2 per day for arm 1 to 4, respectively. 1 s.c. injection per day for 5 days.
Also known as: IL2
Kinetic parameters of Treg proportions variation within CD4+ T cells in peripheral blood
Time frame: from Day+0 to Day+60
Improvement of residual secretion of insulin assessed by the AUC of peptide C during a standardized test meal in IL-2 vs placebo treated patients
Time frame: at Day+0 and Day+60
The record gives a start of May 2011, a primary completion of Oct 2011 and a completion of Apr 2012. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in May 2011. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Aldesleukin
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