Trials of immunotherapy to preserve beta-cell function of prediabetic and new-onset patient trials.

Abstract

In that quantitative assays for a series of islet autoantigens were developed as the trial was proceeding, autoantibodies for GAD65, ICA512 (IA-2), and insulin autoantibodies were also measured. A general conclusion is that future prevention trials will use measurement of these autoantibodies rather than the cytoplasmic ICA assay [2]. As a general rule, expression of multiple “biochemical” autoantibodies is associated with very high future diabetes risk (approaching 90% at 10 years with ≥ two of the autoantibodies vs approximately 20% with one of the autoantibodies) [3]. At present, early diagnosis is the only benefit of type 1 diabetes prediction, but studies in Denver presented in abstract form [4] indicate an almost tenfold decreased hospitalization at onset (approximately 40% vs 4%) for those known to be at risk because of expression of these autoantibodies compared to nonscreened individuals. A companion trial of oral insulin, designed to induce oral tolerance in ICA-positive relatives with a significant but lower diabetes risk, has not yet been presented as a full manuscript. In 2004, the Trialnet organization will likely initiate additional trials for diabetes prevention, as it begins a series of trials in patients with new-onset diabetes. There are Trialnet sites throughout the United States and Canada, as well as affiliated sites outside of the United States.