Diabetes and other autoimmune endocrine diseases

Oral

The Effects of Oral Insulin in Individuals at Risk of Type 1 Diabetes; A Trialnet Randomized Clinical Trial

Thursday, June 15
5:45 PM - 7:00 PM

We screened 138,385 relatives of individuals with type 1 diabetes for diabetes autoantibodies.  3,583 were identified as insulin autoantibody (mIAA) positive. Of these, 581 with insulin autoantibodies (miAA) and either ICA or GAD and IA-2 were placed into one of 4 stratum according to antibodies and first phase insulin release determined from intravenous glucose tolerance testing.  All subjects had normal glucose tolerance at entry and therefore at stage 1 of diabetes.  Subjects were randomized to treatment with 7.5 mg oral insulin daily or placebo and followed for development of stage 3 diabetes (clinical diabetes onset).   A separate mechanistic study has randomized 92 individuals with mIAA and at least one other antibody to 6 months of either 67.5 mg daily oral insulin or 500 mg every other week to examine safety of higher doses and whether changes in antibodies or CD8 T cells can be detected.  Results: This is the largest placebo control randomized trial ever conducted in those with Stage 1 of diabetes, with up to 10 years of follow-up (median 2.6 years).  The median age at enrollment was 8.2 years.  The first subject was randomized in 2007 and the last in December 2015.  Results of the clinical trial will be presented at the ADA meeting, June 12, 2017 and are embargoed until then.  At FOCIS, this and additional data will be available from the primary trial and the first 40 subjects of the companion mechanistic study.

Carla Greenbaum

Director, Diabetes Program
Benaroya Research Institute

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    Schatz Desmond

    Professor and Associate Chairman of Pediatrics
    University of Florida College of Medicine

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      Skyler Jay

      Professor of Medicine
      University of Miami School of Medicine

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        Jeff Krischer

        Professor Departments of Pediatrics and Internal Medicine
        USF Health Informatics Institute, University of South Florida College of Medicine

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          Peter Gottlieb

          Professor Pediatrics and Medicine
          Barbara Davis Center University of Colorado School of Medicine

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            The Effects of Oral Insulin in Individuals at Risk of Type 1 Diabetes; A Trialnet Randomized Clinical Trial



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