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

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Aldesleukin; Interleukin-2

Criteria

Inclusion Criteria:

• Age [18-50] years;

• With a T1D:

• Treated with insulin for ≤ 2 years,

• With at least one auto-antibody among: anti-islet, anti-GAD, anti-IA2, anti-ZnT8 ;

• No clinically relevant abnormal value for hematology, biochemistry, liver and kidney function

• Lymphocyte [1000-4000]/ mm3

• Informed consent signed by the patient and the investigator before any intervention necessary for the trial.

Exclusion Criteria:

• Contra-indications to IL2 :

• Hypersensibility to IL-2 or its excipients,

• Severe cardiopathy

• Ongoing infection requiring antibiotherapy,

• O2 Saturation ≤ 90 %

• Severe impairment of a vital organ

• Previous organ allograft

• Non authorized concomitant treatment : i.e. immuno-modulators, cytotoxic, drug modifying glycemia

• Cancer progressing or cured for less than 5 years except for primary basal cell carcinoma or carcinoma in situ of the uterine cervix.

• Participation to another clinical investigation in < 3 months

• Pregnant or lactating women

• Male or female in age of procreation without efficient contraception during the study

• No affiliation to National Health Insurance