Antibody responses to insulin in the oral arm of the diabetes prevention trial – type 1

Objective: The oral arm of the DPT-1 study tested the hypothesis that oral administration of 7.5mg insulin daily could delay or prevent type 1 diabetes (T1DM) in nondiabetic islet cell antibody and PEG-insulin autoantibody (IAA) positive relatives of T1DM patients with a predicted 5-year diabetes risk of 26–50% in a randomized, double-masked, placebo-controlled clinical trial. The study reported no significant difference in diabetes progression between insulin and placebo treated relatives overall, but a post-hoc sub-analysis showed benefit by treatment in relatives with high insulin autoantibody (IAA) levels. H…