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

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

Outcome

Met primary endpoint

paper IL2 induced a dose-dependent increase in the proportion of Treg cells, significant at all doses compared with placebo PMID 24622415 ↗

paper 0.33 MIU 2.8% [1.2], p=0.0039; 1 MIU 3.9% [1.8], p=0.0039; 3 MIU 4.8% [1.9] p=0.0039. PMID 24622415 ↗

Publications

• Hartemann A, Bensimon G, Payan CA, Jacqueminet S, Bourron O, Nicolas N, Fonfrede M, Rosenzwajg M, Bernard C, Klatzmann D. Low-dose interleukin 2 in patients with type 1 diabetes: a phase 1/2 randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2013 Dec;1(4):295-305. doi: 10.1016/S2213-8587(13)70113-X. Epub 2013 Oct 8.

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

Indications