| Outcome Measures: |
Primary: Change from baseline of CD4 T regulatory cells, CD4 T effector cells and CD25 expression on T regulatory cells during treatment with ultra low dose IL-2, Fluorescence-activated cell sorting, Visits 2-12 (day 0 up to a maximum of approximately day 98 depending on treatment assignment) | Secondary: T regulatory cell number, phenotype and proliferation, Measured by fluorescence-activated cell sorting, Visits 2-12 (day 0 up to a maximum of approximately day 98 depending on treatment assignment)|T effector cell number, phenotype and proliferation, Measured by fluorescence-activated cell sorting, Visits 2-12 (day 0 up to a maximum of approximately day 98 depending on treatment assignment)|Natural Killer cell number, phenotype and proliferation, Measured by fluorescence-activated cell sorting, Visits 2-12 (day 0 up to a maximum of approximately day 98 depending on treatment assignment)|B lymphocyte cell number, phenotype and proliferation, Measured by fluorescence-activated cell sorting, Visits 2-12 (day 0 up to a maximum of approximately day 98 depending on treatment assignment)|T cell and Natural killer cell intracellular signalling, Measured by fluorescence-activated cell sorting, Visits 2-12 (day 0 up to a maximum of approximately day 98 depending on treatment assignment)|Full blood count, Measured by automatic analyser, Visits 1-12 (between day -30 and day -1 up to a maximum of approximately day 98 depending on treatment assignment)|Blood levels of IL-2, IL-6, IL-10, TNF-alpha, soluble CD25, IP-10, soluble rIL-6, and CRP, Measured by enzyme-linked immunosorbent assay, Visits 2-12 (day 0 up to a maximum of approximately day 98 depending on treatment assignment)|Change in metabolic control, Blood glucose, HbA1c, C-peptide, insulin use and autoantibody status, Visits 1-12 (between day -30 and day -1 up to a maximum of approximately day 98 depending on treatment assignment)|Safety and tolerability, Assessed by clinical history, physical examination, temperature, blood pressure, heart rate, 12-Lead electrocardiogram (ECGs), clinical laboratory tests, and adverse event recording, Visits 1-12 (between day -30 and day -1 up to a maximum of approximately day 98 depending on treatment assignment) | Other: Genotype of T1D associated loci, Measured by immunochip, Visit 1 (between day -30 and day -1)|Gene expression analysis of purified lymphocyte subsets and peripheral blood mononucleated cells, Measured by RNA sequencing, Visits 2-12 (day 0 up to a maximum of approximately day 98 depending on treatment assignment)|IL-2 sensitivity of T regulatory, T effector and NK subsets, Measured by fluorescence-activated cell sorting, Visits 2-12 (day 0 up to a maximum of approximately day 98 depending on treatment assignment)|Treg suppression and T effector proliferation assays, Measured by radioactive thymidine assay and/or fluorescence-activated cell sorting, Visits 2-12 (day 0 up to a maximum of approximately day 98 depending on treatment assignment)|Antigen specific T cell assays, Measured fluorescence-activated cell sorting and/or Enzyme-Linked ImmunoSpot (ELISPOT) assay, Visits 2-12 (day 0 up to a maximum of approximately day 98 depending on treatment assignment)|Sysmex® analysis of whole blood, Measured by automatic analyser, Visits 2-12 (day 0 up to a maximum of approximately day 98 depending on treatment assignment)|Epigenetic analysis of analysis of purified lymphocyte subsets and peripheral blood, Measured by Bisulphite sequencing of DNA, Visits 2-12 (day 0 up to a maximum of approximately day 98 depending on treatment assignment)|Serum/plasma level of cytokines, soluble receptors and inflammatory markers, Measured by enzyme-linked immunosorbent assay, Visits 2-12 (day 0 up to a maximum of approximately day 98 depending on treatment assignment)|Serum/plasma and cellular metabolites, Mass spectrometry, Visits 1-12 (between day -30 and day -1 up to a maximum of approximately day 98 depending on treatment assignment)|Recruitment analysis, Analysis of DILfrequency recruitment database, Visit 1 (between day -30 and day -1)
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