Abstract
INTRODUCTION: LY2963016 insulin glargine (LY IGlar), a biosimilar of Lantus® insulin glargine (IGlar), demonstrated comparable efficacy and safety versus the reference product in Chinese patients with type 1 diabetes mellitus (T1DM) in the randomized, phase III ABES trial. This post hoc analysis aimed to provide the first evidence for switching from IGlar to LY IGlar in Chinese patients with T1DM. METHODS: This analysis included 210/272 patients with T1DM (77.2%) from the ABES trial who were receiving IGlar at screening. We compared antihyperglycemic efficacy, safety, and immunogenicity in patients randomized to LY IGlar (n = 104) versus those who continued to receive IGlar (n = 106). RESULTS: There was no significant difference between groups in least-squares mean (LSMean) change in HbA1c from baseline to 24 weeks (LY IGlar - 0.10%, IGlar - 0.08%; LSMean difference [95% confidence interval] - 0.02% [- 0.24, 0.19]). At 24 weeks (last observation carried forward), a similar proportion of patients in each group achieved glycated hemoglobin less than 7.0% (LY IGlar 26.5%, IGlar 32.1%; P = 0.447) and 6.5% or less (LY IGlar 16.7%, IGlar 20.8%; P = 0.482). There were no significant differences between groups in LSMean of self-monitored blood glucose values, or total or basal insulin dose at 24 weeks. Patients in the LY IGlar and IGlar groups had a similar incidence of total hypoglycemia (blood glucose level 70 mg/dL or less, 91.4% vs. 92.5%) and treatment-emergent adverse events (AEs; 75.0% vs. 67.0%), and a low and similar incidence of serious AEs, injection site AEs, and allergic AEs. Similar proportions of patients in the LY IGlar and IGlar groups had treatment-emergent antibody responses (LY IGlar 27.2%, IGlar 28.3%) and detectable insulin antibodies (LY IGlar 52.4%, IGlar 53.8%). CONCLUSION: In Chinese patients with T1DM previously treated with IGlar, switching to LY IGlar for 24 weeks resulted in similar efficacy and safety outcomes as remaining on IGlar therapy. CLINICAL TRIAL REGISTRATION: NCT03338023.