Abstract
Background/Aims: The DIAMYD Phase II study tested whether GAD65 antigen-specific immune intervention could preserve endogenous insulin secretion in patients with latent autoimmune diabetes in adults (LADA). Forty-seven LADA patients received 2 subcutaneous injections of alum-formulated recombinant human GAD65 (4µg, 20µg, 100µg or 500µg) or placebo at intervals of 4 weeks and were followed thereafter for 30 months with respect to metabolic outcome. Here, we asked whether GAD autoantibody (GADA) affinity is affected by vaccination with rhGAD65 and associated with fasting C-peptide levels in LADA patients.
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