Type 1 Diabetes Clinical Trial
Official title:
Adaptive Study of IL-2 Dose Frequency on Regulatory T Cells in Type 1 Diabetes (DILfrequency)
Type 1 diabetes (T1D) is the most common severe autoimmune disease worldwide and is caused by
the body's immune destruction of its own insulin producing pancreatic beta cells leading to
insulin deficiency and development of elevated blood sugars. Currently, medical management of
T1D focuses on intensive insulin replacement therapy to limit complications (retinopathy,
nephropathy, neuropathy); nevertheless clinical outcomes remain suboptimal. 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.
Genetics are in part the cause of T1D and the majority of genes contributing to T1D produce
proteins involved in immune regulation (called "tolerance"). A key player in immune tolerance
is a molecule called interleukin-2 (IL-2) which enhances the ability of cells called T
regulatory (Treg) cells to suppress the destruction the insulin producing beta cells.
Aldesleukin is a human recombinant IL-2 product produced by recombinant DNA technology using
a genetically engineered E. coli strain expressing an analogue of the human IL-2 gene. There
is substantial data to suggest that ultra-low doses (ULD) of IL-2 (aldesleukin) can arrest
the autoimmune mediated destruction of pancreatic beta cells by the induction of functional
Treg cells.
The former study "Adaptive study of IL-2 dose on regulatory T cells in type 1 diabetes"
(DILT1D) (NCT 01827735) was a single dose mechanistic study designed to establish the doses
of IL-2 (aldesleukin) required to induce a minimal Treg increase (0.1 fold from baseline) or
to induce a slightly larger Treg increase (0.2 fold from baseline) (maximal increase).
Following on from the DILT1D study, the goal of the DILfrequency study is to use an adaptive
design to determine the optimal dose and frequency of ULD IL-2 (aldesleukin) to maximize Treg
function by frequently injecting ultra-low doses of IL-2 (aldesleukin). The responsiveness of
each T1D participant to a particular frequency of IL-2 (aldesleukin) administration informs
the frequency of dosing given to the next patient. This strategy focuses on improving the
function of regulatory T cells that are exquisitely sensitive to IL-2 (aldesleukin).
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