title: Efficacy and safety of LY2963016 insulin glargine in patients with type 1 and type 2 diabetes previously treated with insulin glargine.
abstract: The safety and efficacy of LY2963016 insulin glargine (LY IGlar) and Lantus insulin glargine (IGlar), products with identical primary amino acid sequences, were assessed in subgroups of patients with type 1 (T1D, n = 452) or type 2 diabetes (T2D, n = 299) reporting prestudy IGlar treatment in 52-week open-label (ELEMENT-1) and 24-week double-blind (ELEMENT-2) studies. At randomization, patients transitioned from their prestudy IGlar to equivalent doses of LY IGlar or IGlar. Primary efficacy (change in glycated haemoglobin from baseline to 24 weeks), other efficacy and select safety outcomes of LY IGlar were compared with those of IGlar. Continuous data were analysed using analysis of covariance, categorical data by Fisher's exact test, and treatment comparisons for hypoglycaemia by Wilcoxon test. No statistically significant treatment differences were identified for efficacy and safety outcomes except for weight change (T1D), overall incidence of detectable insulin antibodies (T2D), and serious adverse events (T2D). These differences were neither consistently observed across both studies nor observed in the total study populations, and their magnitude suggests they were not clinically meaningful. LY IGlar and IGlar show similar efficacy and safety profiles in patients reporting prestudy IGlar treatment.
authors.affiliation: Lilly Deutschland GmbH, Bad Homburg, Germany.
authors.forename: I
authors.initials: I
authors.lastname: Hadjiyianni
authors.affiliation: Gemeinschaftspraxis für Innere Medizin und Diabetologie, Hamburg, Germany.
authors.forename: D
authors.initials: D
authors.lastname: Dahl
authors.affiliation: Eli Lilly and Company, Indianapolis, IN, USA.
authors.forename: L B
authors.initials: LB
authors.lastname: Lacaya
authors.affiliation: Eli Lilly and Company, Indianapolis, IN, USA.
authors.forename: R K
authors.initials: RK
authors.lastname: Pollom
authors.affiliation: Eli Lilly and Company, Indianapolis, IN, USA.|Ditmanson Medical Foundation Chiayi Christian Hospital, Chiayi City, Taiwan.
authors.forename: C L
authors.initials: CL
authors.lastname: Chang
authors.affiliation: Eli Lilly and Company, Indianapolis, IN, USA.
authors.forename: L L
authors.initials: LL
authors.lastname: Ilag
mesh_terms: D059451:Biosimilar Pharmaceuticals / Q000009:adverse effects / Q000627:therapeutic use*; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D004311:Double-Blind Method; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D006943:Hyperglycemia / Q000517:prevention & control*; D007003:Hypoglycemia / Q000139:chemically induced / Q000517:prevention & control*; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000069036:Insulin Glargine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D059451:Biosimilar Pharmaceuticals; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D000069036:Insulin Glargine; C000606659:LY2963016 insulin glargine; C517652:hemoglobin A1c protein, human
keywords: LY2963016 insulin glargine; biosimilar insulin; insulin glargine