Effect of High Dose Oral Insulin in Children with Stage 1 Type 1 Diabetes: The Fr1da – Insulin – Intervention Randomized Controlled Trial

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Objective. Oral administration of antigen can induce immunological tolerance. Insulin is an autoantigen in childhood type 1 diabetes. We tested the effect of treatment with high-dose oral insulin on disease progression and immune responses to insulin in children with stage 1 type 1 diabetes. Research Design and Methods. We conducted a phase-2, randomized, placebo-controlled, double-blind trial in children with stage 1 type 1 diabetes who received daily oral insulin (3 months 7.5 mg/day, 9 months 67.5 mg/day; n=110) or placebo (n=110) for 12 months. The co-primary outcomes were: (1) time from baseline to dysglycemia or clinical diabetes, and (2) an increased immune response to insulin within 12 months of treatment (assessed in the first 90 participants). Results. Among 220 participants (112, females; median age, 4.8 years; interquartile range, 3.6 – 6.2), 179 completed the trial. Dysglycemia or diabetes developed in 87 participants (46 oral insulin, 41 placebo; hazard ratio 1.07, 95% CI 0.66, 1.73; P=0.74). The 5-year progression rate was 40% (95% CI 30%, 51%) in each group. A modest treatment interaction was found with INS rs689 genotype (P=0.03). Increases in immune response to insulin were observed in 11 of 44 (25%) participants in the oral insulin group and 13 of 42 (31%) in the placebo group (P=0.63). Oral insulin was well tolerated. No significant study-related adverse events occurred. Conclusions. In children with stage 1 type 1 diabetes, one year of high-dose oral insulin did not alter progression to dysglycemia or diabetes or the immune response to insulin.

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