| Outcome Measures: |
Primary: The activation of a CD4+ T cell immune response against insulin, The primary outcome for immune efficacy is the activation of an immune response (antibody or CD4+ T cell) against insulin. Each participant will be categorized as reaching a response or not. A response is defined as a \>2-fold increase that reaches a stimulation index of \>3.0., change from baseline (visit 1) in CD4+ T cell response measured as a stimulation index at 12 months of treatment|The activation of an antibody response against insulin., An antibody response is defined as an increase from baseline of \>10 cpm in serum IgG binding to insulin from baseline to 12 months, or a positive salivary IgA binding to insulin at 12 months., change from baseline (visit 1) in antibodies measured as serum IgG binding to insulin (unit of measure, cpm) and salivary IgA binding to insulin (unit of measure, cpm) at 12 months of treatment | Secondary: Gene expression of CD4+ T cell response to insulin., The number of responders in the insulin treated group will be compared with the number of responders in the placebo treated group. As secondary outcomes, responder status in individual measures of antibody response to insulin, CD4+ T cells response to insulin, and CD4+ T cell response to proinsulin will be compared between insulin treated and placebo treated groups. For a mechanistic secondary outcome, the proportion of insulin responsive and of proinsulin responsive CD4+ T cells that have a Treg gene expression profile, an IFNg profile, and the Treg/IFNg cell ratio will be compared between the insulin treated and placebo treated groups., gene expression profile measurement on insulin-responsive CD4+ T cells at 12 months visit.|Hypoglycemia, Metabolic changes within two hours after receiving study drug. This will be performed at the first administration of oral insulin or placebo at each new dose (visit 1, visit 2, and visit 3). At these visits, blood glucose concentrations will be measured at 0 minutes, 30 minutes, 60 minutes, and 120 minutes after receiving study drug to determine whether the treatment induces hypoglycaemia which is defined as \<50 mg/dl (\<2.8 mmol/L)., Measured at baseline (visit 1) and at each subsequent change in dose (visits 2 and 3)|change in total IgE concentration, The purpose is to detect an unexpected allergy to study drug. Total IgE will be measured at visit 1 and at the end of each dose or oral insulin or placebo. The change in concentration from baseline will be reported and compared between placebo and the study drug treated participants for each of the three doses., A change from baseline (visit 1) in total IgE concentration at 3 months of treatment,change from baseline (visit 1) in total IgE concentration at 6 months of treatment,change from baseline (visit 1) in total IgE concentration at 12 months of treatment|Study drug specific IgE, The purpose is to detect an unexpected allergy to study drug. Insulin-specific IgE (cpm) will be measured using a radiobinding immunoprecipitation assay at visit 1 and at the end of treatment. Each child will be classified as positive or negative for the appearance of IgE antibodies against insulin after 12 months, and the number of children with IgE antibodies against insulin will be reported in the placebo and study drug treated groups., Baseline (visit 1) and end of treatment (12 months).|GAD and IA-2 autoantibodies, The purpose is to detect seroconversion to islet autoantibody positive. Measurements are performed using a radiobinding immunoprecipitation assay. Children who become positive on two occasions during follow-up will stop treatment. The number of children who develop autoantibodies to GAD or IA-2 in he placebo and study drug treated groups will be compared., Measured at baseline where they must be negative, and at 3 months, 6 months, 9 months, and 12 months. | Other: Adverse events, Adverse events are reported through out the period of participation of each participants. Analysis will compare the number and frequency of adverse events during treatment with study drug (total and during each dose period) to the number and frequency of adverse events in the placebo treated children., Duration of participation from study visit 1 until 12 months visit or drop out.
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