| Outcome Measures: |
Primary: Primary Safety Endpoints (composite outcome measure), 1. Rate, frequency and severity of all adverse events including; hypoglycemic episodes; injection reactions; hypersensitivity reactions; evidence of infection and posterior leukoencephalopathy syndrome. 2. Vital signs, standard hematology and chemistry tests, physical examinations., 12 months | Secondary: Immunological Endpoints (composite outcome measure), 1. Immune phenotyping via flow cytometry of all Interleukin (IL)-12, IL-23, IL-17, Interferon(IFN)-γ secreting immune subsets. 2. Basic immune phenotyping of white blood cell subsets. 3. Human leukocyte antigen(HLA)- A, B, C, DR, DP, DQ typing. 4. Fluorospot (ELISpot) analysis for IL-17 and IFN-γ secretion in response to whole insulin and antigens for Cluster of differentiation (CD)8+ and CD4+ T cells . 5. Luminex assessment of serum cytokines IL-17, IFN-γ, IL-12 and IL-23. 6. Regulatory T cell : Effector T cell ratio 7. CD154 based assays to determine diabetogenic antigen specific responses of T helper cells. 8. Epigenetic assessment of Treg phenotype and function., 12 months|Exploratory (composite outcome measure), 1. Mixed-meal tolerance test (MMTT) - stimulated 2-hour C-peptide area under the curve (AUC) at weeks 4, 28 and 52. 2. Insulin use in units per kg body weight per day at weeks 4, 16, 28, 40 and 52. 3. HbA1C levels at weeks 4, 16, 28, 40 and 52., 12 months
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