drugset / Trial / NCT01353833
Dose-effect Relationship of Low-dose IL-2 in Type 1 Diabetes
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |