title: Clinical Outcomes of Patients with Diabetes Who Exhibit Upper-Quartile Insulin Antibody Responses After Treatment with LY2963016 or Lantus®Insulin Glargine.
abstract: BACKGROUND
  We compared insulin antibody response (IAR) profiles in patients with type 1 diabetes (T1D) or type 2 diabetes (T2D) who received LY2963016 insulin glargine (LY IGlar) or Lantus®insulin glargine (IGlar) and evaluated the potential relationship between higher IARs and clinical and safety outcomes with a focus on patients who exhibited antibody responses in the upper quartile.
  
  
  METHODS
  Data from ELEMENT-1 (52-week open-label in T1D) and ELEMENT-2 (24-week, double-blind study in T2D) were analyzed. Maximum postbaseline IAR levels and proportions of patients in the upper quartile of maximum antibody percent binding (UQMAPB; patients with maximum postbaseline percent binding in the highest 25% of maximum values observed) were compared for differential treatment effects on clinical efficacy outcomes and incidence of adverse events. Continuous outcomes were analyzed by analysis of covariance. Categorical data were analyzed by the Cochran-Mantel-Haenszel or Breslow-Day test.
  
  
  RESULTS
  In both studies (N = 532 evaluable patients with T1D; N = 730 with T2D), no statistically significant differences between LY IGlar and IGlar were observed for maximum antibody percent binding (MAPB) levels or for proportions of patients in the respective UQMAPB. No statistically significant differential treatment effects were observed in the relationship between MAPB and clinical efficacy and safety outcomes.
  
  
  CONCLUSIONS
  Maximum postbaseline IAR levels and the proportion of patients with high IAR levels were similar for LY IGlar and IGlar. High antibody levels did not affect clinical outcomes. These results add further evidence supporting similar IARs of LY IGlar and IGlar.
  
  
  BACKGROUND
  Eli Lilly and Company and Boehringer-Ingelheim.
authors.affiliation: Lilly Corporate Center, Eli Lilly and Company, Indianapolis, IN, 46285, USA. ilag_liza_l@lilly.com.
authors.forename: Liza L
authors.initials: LL
authors.lastname: Ilag
authors.affiliation: Lilly Corporate Center, Eli Lilly and Company, Indianapolis, IN, 46285, USA.
authors.forename: Timothy M
authors.initials: TM
authors.lastname: Costigan
authors.affiliation: Lilly Corporate Center, Eli Lilly and Company, Indianapolis, IN, 46285, USA.
authors.forename: Mark A
authors.initials: MA
authors.lastname: Deeg
authors.affiliation: Lilly Corporate Center, Eli Lilly and Company, Indianapolis, IN, 46285, USA.
authors.forename: Robyn K
authors.initials: RK
authors.lastname: Pollom
authors.affiliation: Lilly Corporate Center, Eli Lilly and Company, Indianapolis, IN, 46285, USA.|Ditmanson Medical Foundation Chiayi Christian Hospital, 539 Jhongsiao Road, Chiayi, Taiwan.
authors.forename: Curtis L
authors.initials: CL
authors.lastname: Chang
authors.affiliation: Lilly Corporate Center, Eli Lilly and Company, Indianapolis, IN, 46285, USA.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Konrad
authors.affiliation: Lilly Corporate Center, Eli Lilly and Company, Indianapolis, IN, 46285, USA.
authors.forename: Melvin J
authors.initials: MJ
authors.lastname: Prince
keywords: Insulin antibody response; Insulin glargine; LY2963016 insulin glargine