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 patients with T1DM (17.0% vs. 20.6% at baseline; 40.4% vs. 39.3% overall) or T2DM (5.5% vs. 3.6% at baseline; 15.3% vs. 11.0% overall). The incidences of treatment emergent antibody responses (TEAR) and treatment-emergent allergic events did not differ (p > 0.05) between LY IGlar and IGlar in both T1DM (10.9% vs. 9.4% with TEAR; 7.5% vs. 4.1% with ≥1 treatment-emergent allergic events) and T2DM patients (3.8% vs. 3.8% with TEAR; 5.6% vs. 7.1% with ≥1 treatment-emergent allergic events).

LS mean change in HbA1c was not affected by TEAR status (p > 0.05 for treatment-by-TEAR interaction) in both T1DM patients with TEAR/no TEAR (LY IGlar vs. IGlar: -0.38%/-0.25% vs. -0.23%/-0.28%) and T2DM patients (-1.2%/-1.3% vs. -1.7%/-1.3%). Similarly, other clinical outcomes (basal insulin dose; total hypoglycemia) were not affected by TEAR status in patients with T1DM or T2DM (p > 0.05).

Conclusions: These clinical safety data demonstrate a highly similar immunogenicity profile of LY IGlar to IGlar, with no effects of anti-insulin glargine antibodies on efficacy and safety outcomes in patients with T1DM or T2DM.