CLINICAL TRIAL: ORAL INSULIN IN RELATIVES AT RISK FOR TYPE I DIABETES MELLITUS

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Study Design: This is an NIH TrialNet study that is a follow up study to our initial oral insulin prevention trial. Subgroup analysis of that study strongly suggests efficiency in the subgroup we are proposing to study here. The study is a 2-arm, multicenter, randomized, double-masked, placebo controlled trial. Subjects: A fixed target sample size has not been specified. Rather, the study is designed as a maximum information trial in which subjects are recruited and followed until the required amount of statistical information is achieved that provides 85% power to detect a 40% risk reduction using a one-sided logrank test at the 0.05 level. Treatment Description: Subjects will receive oral insulin 7.5 mg of recombinant human insulin crystals or placebo in capsules. Objective: The primary objective is to determine whether intervention with repeated oral administration of recombinant human insulin will prevent or delay the development of clinical Type 1 Diabetes Mellitus (T1DM) in subjects at risk for T1DM. Primary Outcome: The primary outcome is the elapsed time from random treatment assignment to the development of diabetes among those enrolled in the primary analysis cohort consisting of subjects with insulin autoimmunity and absence of metabolic abnormalities. Criteria for diabetes onset are as defined by the American Diabetes Association (ADA) based on glucose testing, or the presence of symptoms and unequivocal hyperglycemia.