Evaluation of high insulin antibody response and related clinical outcomes in patients with T1DM or T2DM treated with LY2963016 and Lantus®

Objective: LY2963016 (LY IGlar) and Lantus® (IGlar) are insulin glargine products with similar efficacy and safety including insulin antibody responses that are low and similar between treatments. This evaluation assessed maximal antibody responses and relationships to clinical outcomes. Methods: Data were analyzed from the ELEMENT 1 (T1DM, 52-week, open-label, LY IGlar 265 patients, IGlar 267 patients) and ELEMENT 2 (T2DM, 24-week, double-blind, LY IGlar 365 patients, IGlar 365 patients) studies. Maximum post-baseline antibody levels (medians) and proportion of patients in the upper quartile of maximum antibody…