drugset / Trial / NCT01353833

Dose-effect Relationship of Low-dose IL-2 in Type 1 Diabetes

NCT01353833

Phase 1/2 Completed 25 enrolled Assistance Publique - Hôpitaux de Paris
RandomizedParallel-groupDouble-blindTreatment

Summary

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.

Timeline

Start
2011-05
Primary completion
2011-10
Completion
2012-04

Drugs

EvaluationDrugModalityDoseRoute
Subject aldesleukin Protein / enzyme biologic 330000 iu Subcutaneous
Subject aldesleukin Protein / enzyme biologic 1e+06 iu Subcutaneous
Subject aldesleukin Protein / enzyme biologic 3e+06 iu Subcutaneous