Evaluation of immunogenicity of LY2963016 insulin glargine compared with Lantus insulin glargine in patients with T1DM or T2DM

Introduction: The immunogenicity of LY2963016 (LY IGlar) and of Lantus® (IGlar), insulin glargine products with identical amino acid sequences, were compared, as subtle differences in protein products manufactured using living cells may affect the immune response and clinical outcomes. Methods: Anti-insulin glargine antibodies were measured in 52-wk and 24-wk studies in patients with T1DM (open-label) and T2DM (double-blind), respectively. Results: Proportions of patients with detectable antibodies at baseline and throughout the treatment period (overall) were similar (p > 0.05) for LY IGlar vs. IGlar in patient…