Diabetologie und Stoffwechsel 2016; 11 - P248
DOI: 10.1055/s-0036-1580995

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

L Ilag 1, RK Pollom 1, T Costigan 1, J Zielonka 1, R Konrad 1, M Deeg 1, M Prince 1
  • 1Eli Lilly and Company, Indianapolis, United States

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 % binding (UQMAPB: patients with maximum post-baseline % binding in the upper 25% of maximum values observed) were compared for differential treatment effects on outcomes.

Results: There were no significant differences in maximum post-baseline antibody levels (ELEMENT 1: LY IGlar 0.84%, IGlar 0.90%, p = 0.96; ELEMENT 2: LY IGlar 0.56%, IGlar 0.78%, p = 0.49) or the proportions of patients in the UQMAPB (ELEMENT 1: LY IGlar 10.9%, IGlar 9.0%, p = 0.47; ELEMENT 2: LY IGlar 3.8%, IGlar 2.7%, p = 0.53). There were no significant differential treatment effects in the relationship between maximum post-baseline % binding and outcomes (ie, changes in HbA1c, basal insulin dose, weight, and total hypoglycemia; all interaction p > 0.05). Similar proportions of patients and AE frequencies were noted within UQMAPB. No significant differential treatment effect of UQMAPB (yes/no) was observed with regard to clinical outcomes.

Conclusions: Patients treated with LY IGlar and IGlar had similar maximum antibody responses, with similar proportions having high antibody response. High antibody levels were not associated with effects on clinical outcomes.