Oral Insulin for Prevention of Diabetes in Relatives at Risk for Type 1 Diabetes Mellitus
The primary objective of the TrialNet Oral Insulin Trial is to determine whether intervention with repeated oral administration of recombinant human insulin, the potential autoantigen, will prevent or delay the development of clinical Type 1 Diabetes Mellitus (T1DM) in non-diabetic relatives of patients with T1DM who are positive for insulin autoantibodies but who do not have a metabolic defect (as the Primary Analysis Stratum). This intervention will be compared with placebo given in a double-masked fashion. Secondary objectives include the description of the effects of treatment with oral insulin versus placebo in other categories of subjects defined using different combinations of autoantibodies and metabolic status (the Secondary Analysis Strata) and an assessment of the consistency of treatment effect among strata. Secondary objectives also include the assessment of the effects of treatment on immunologic and metabolic markers, and the association of these markers with the risk of diabetes onset, among other possible risk factors.
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