In a small pilot study, oral insulin challenges showed promise in developing immune responses in at-risk children. Oral antigen exposure has been a successful strategy for developing tolerance in some allergies. In a randomized, double-blind, multinational, phase 1/2 trial, researchers examined the safety of escalating doses of oral insulin for generating an immune response in children (ages 2–7 years) at high risk for type 1 diabetes.
Twenty-five children with a family history of diabetes and high-risk human leukocyte antigen haplotypes but without anti-insulin antibodies were randomized to placebo or one of three oral insulin regimens: 2.5 mg/day for 6 months followed by 7.5 mg/day for 3 to 12 months; 2.5 mg/day for 6 months followed by 22.5 mg/day for 3 to12 months; or 7.5 mg/day for 6 months followed by 67.5 mg/day for 3 to 12 months. Antibody or T-cell immune responses were…
