Type 1 Diabetes Clinical Trial
Official title:
Adaptive Study of IL-2 Dose on Regulatory T Cells in Type 1 Diabetes (DILT1D)
Type 1 diabetes is the most common severe chronic autoimmune disease worldwide and is caused
by the autoimmune (loss of self tolerance) mediated destruction of the insulin producing
pancreatic beta cells thus leading to insulin deficiency and development of hyperglycaemia.
Currently, medical management of type 1 diabetes focuses on intensive insulin replacement
therapy to limit complications (retinopathy, nephropathy, neuropathy); nevertheless clinical
outcomes remain sub optimal. There are intensive efforts to design novel immunotherapies that
can arrest the autoimmune process and thereby preserve residual insulin production leading to
fewer complications and better clinical outcomes.
The vast majority of genes that contribute to susceptibility to type 1 diabetes have been
found to encode proteins involved in immune regulation and function. In particular, several
susceptibility proteins are involved in the interleukin 2 (IL-2) pathway that regulates T
cell activation and tolerance to self antigens. Aldesleukin is a human recombinant IL-2
product produced by recombinant DNA technology using genetically engineered E. coli stain
containing an analog of the human interleukin-2 gene. There is substantial nonclinical,
preclinical and clinical data that ultra low dose IL-2 (aldesleukin) therapy can arrest the
autoimmune mediated destruction of pancreatic beta cells by induction of functional T
regulatory cells. However, prior to embarking on large proof of concept trials in type 1
diabetes it is essential that the optimum dose of IL-2 (aldesleukin) is determined. The
objective of this study is to establish in patients with type 1 diabetes the optimal dose of
IL-2 (aldesleukin) to administer in order to increase T regulatory cell response.
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