Efficacy and safety of low‐dose otelixizumab anti‐ CD 3 monoclonal antibody in preserving C‐peptide secretion in adolescent type 1 diabetes: DEFEND ‐2, a randomized, placebo‐controlled, double‐blind, multi‐centre study

DEFEND‐2 was intended as a confirmatory study to DEFEND‐1, which tested the efficacy and safety of low‐dose otelixizumab (3.1 mg) in 281 adolescents and adults with new‐onset Type 1 diabetes; DEFEND‐2 studied this dose in a population enriched with adolescents. Following lack of efficacy in DEFEND–1, enrolment of new subjects to DEFEND‐2 was suspended; analysis of 6‐month data also showed no efficacy advantage of otelixizumab, but reaffirmed the safety of this dose. These results are important to further understanding of Type 1 diabetes; additional research is needed to establish the optimal dose of otelixizumab.