| Outcome Measures: |
Primary: Baseline change in 2-hour mixed meal-stimulated C-peptide AUC at week 52., Week 52|Rate, frequency and severity of all adverse events including; hypoglycemic episodes; injection reactions; hypersensitivity reactions; evidence of infection and posterior leukoencephalopathy syndrome., Week 52 | Secondary: 2-hour MMTT-stimulated C-peptide AUC at weeks 28 and 78), Weeks 28 and 78|HbA1C and insulin use in units per kg body weight per day at weeks 0, 8, 16, 24, 28, 32, 40, 48, 52, 78., 78 Weeks|Immune phenotyping via flow cytometry of all IL-12, IL-23, IL-17, IFN-γ secreting immune subsets at weeks 0, 32, 52, 78)., 78 Weeks|Basic immune phenotyping of WBC subsets, 78 Weeks|HLA- A, B, C, DR, DP, DQ typing at weeks 0, 8 ,16, 32, 52, 78), 78 Weeks|Fluorospot (ELISpot) analysis for IL-17 and IFN-γ secretion in response to whole insulin and antigens for CD8+ and CD4+ T cells., 78 Weeks|Luminex/Mesoscale assessment of serum cytokines IL-17, IFN-γ, IL-12p40, IL-12p70 and IL-23., 78 Weeks|Regulatory T cell (CD4+ FOXP3+): Effector T cell (CD4+ FOXP3-CD25+) ratio., 78 Weeks|CD154 and CD134 (OX40) based assays to determine diabetogenic antigen specific responses of T helper cells., 52 Weeks|Nanostring assessment of whole blood and PBMC RNA gene expression of IL-17 and IFN-γ family genes., 78 Weeks|Epigenetic assessment of Treg phenotype and function., 78 Weeks|Sequencing and profiling of microbiome., 78 Weeks|Glycaemic variability in continuous glucose monitoring and hypoglycaemia rates., 78 Weeks
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| Locations: |
Mount Sinai Hospital/UHN, Toronto, British Columbia, M5T 3L9, Canada|BCDiabetes, Vancouver, British Columbia, V5Y 3W2, Canada
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