title: Duration of action of two insulin glargine products, LY2963016 insulin glargine and Lantus insulin glargine, in subjects with type 1 diabetes mellitus.
abstract: LY2963016 (LY IGlar) and Lantus (IGlar) are insulin glargine products manufactured by distinct processes, but with identical amino acid sequences. This study compared the duration of action of LY IGlar and IGlar in subjects with type 1 diabetes mellitus (T1DM).
  
  
  
  This was a randomized, double-blind, single-dose, two-period, crossover study. Twenty subjects underwent 42-hour euglycaemic clamps after a single subcutaneous 0.3-U/kg dose of LY IGlar or IGlar. In this study, the duration of action was defined as the time required for blood glucose levels to rise consistently above a predefined cut-off of 8.3 mmol/L (150 mg/dL) from a state of euglycaemia. Blood samples were collected to measure blood glucose for pharmacodynamic (PD) evaluations.
  
  
  
  End of action was reached within 42 hours in 26 of 40 clamps (13 LY IGlar and 13 IGlar). The median duration of action for all subjects was 37.1 and 40.0 hours, and the mean duration of action (calculated using only patients who reached end of action) was 23.8 and 25.5 hours for LY IGlar and IGlar, respectively. The duration of action was demonstrated to be similar between the treatments using time-to-event analysis (log-rank test of equality p = .859). Following administration of LY IGlar and IGlar, the PD parameters of maximum glucose infusion rate (Rmax) and total glucose infusion during the clamp (Gtot) were comparable.
  
  
  
  LY IGlar and IGlar had similar duration of action and comparable PD parameters in subjects with T1DM.
authors.affiliation: Eli Lilly and Company, Indianapolis, Indiana.
authors.forename: Helle
authors.initials: H
authors.lastname: Linnebjerg
authors.affiliation: Lilly-NUS Centre for Clinical Pharmacology, Singapore, Singapore.
authors.forename: Eric Chen Quin
authors.initials: EC
authors.lastname: Lam
authors.affiliation: Eli Lilly and Company, Indianapolis, Indiana.
authors.forename: Xin
authors.initials: X
authors.lastname: Zhang
authors.affiliation: Eli Lilly and Company, Indianapolis, Indiana.
authors.forename: Mary E
authors.initials: ME
authors.lastname: Seger
authors.affiliation: Eli Lilly and Company, Indianapolis, Indiana.
authors.forename: David
authors.initials: D
authors.lastname: Coutant
authors.affiliation: Lilly-NUS Centre for Clinical Pharmacology, Singapore, Singapore.
authors.forename: Laiyi
authors.initials: L
authors.lastname: Chua
authors.affiliation: Profil, Neuss, Germany.
authors.forename: Christoph
authors.initials: C
authors.lastname: Kapitza
authors.affiliation: Profil, Neuss, Germany.
authors.forename: Tim
authors.initials: T
authors.lastname: Heise
mesh_terms: D000328:Adult; D001786:Blood Glucose / Q000187:drug effects* / Q000378:metabolism; D018592:Cross-Over Studies; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy* / Q000378:metabolism; D004311:Double-Blind Method; D005260:Female; D015309:Glucose Clamp Technique; D006801:Humans; D007004:Hypoglycemic Agents / Q000494:pharmacology*; D000069036:Insulin Glargine / Q000031:analogs & derivatives* / Q000494:pharmacology*; D008297:Male; D008875:Middle Aged; D013997:Time Factors
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; C000606659:LY2963016 insulin glargine; D000069036:Insulin Glargine
keywords: basal insulin; biosimilar insulin; clinical trial; pharmacodynamics; phase I-II study; type 1 diabetes