title: Efficacy and safety of LY2963016 insulin glargine compared with insulin glargine (Lantus®) in patients with type 1 diabetes in a randomized controlled trial: the ELEMENT 1 study.
abstract: OBJECTIVE
  To compare the efficacy and safety of LY2963016 insulin glargine (LY IGlar) and the reference product (Lantus®) insulin glargine (IGlar) in patients with type 1 diabetes (T1D).
  
  
  METHODS
  This phase III, randomized, open-label, 52-week study enrolled patients with T1D [glycated haemoglobin (HbA1c) ≤11%] being treated with basal (once-daily) and bolus insulin. Patients were randomized to receive once-daily LY IGlar (n = 268) or IGlar (n = 267) in combination with mealtime insulin lispro for 52 weeks. The primary efficacy outcome was to test the non-inferiority (0.4% and then 0.3% margin) of LY IGlar to IGlar as measured by change in HbA1c from baseline to 24 weeks.
  
  
  RESULTS
  Both treatment groups had similar and significant (p < 0.001) within-group decreases in mean HbA1c values from baseline. LY IGlar met the non-inferiority criteria compared with IGlar for change in HbA1c from baseline to 24 weeks [-0.35 vs -0.46%, least-squares mean difference 0.108% (95% confidence interval -0.002 to 0.219), p > 0.05]. There were no significant (p > 0.05) treatment differences in other efficacy measures, including proportion of patients reaching HbA1c <7%, daily mean blood glucose, and insulin dose at 24 and 52 weeks. At 52 weeks, similar findings were observed between LY IGlar and IGlar for safety outcomes, including adverse events, allergic reactions, hypoglycaemia, weight change and insulin antibodies.
  
  
  CONCLUSIONS
  Both LY IGlar and IGlar, when used in combination with mealtime insulin lispro, provided effective and similar glucose control and similar safety profiles.
authors.affiliation: Texas Diabetes & Endocrinology, Austin, TX, USA.
authors.forename: T C
authors.initials: TC
authors.lastname: Blevins
authors.affiliation: Gemeinschaftspraxis für Innere Medizin und Diabetologie, Hamburg, Germany.
authors.forename: D
authors.initials: D
authors.lastname: Dahl
authors.affiliation: Dallas Diabetes and Endocrine Center at Medical City, Dallas, TX, USA.
authors.forename: J
authors.initials: J
authors.lastname: Rosenstock
authors.affiliation: Eli Lilly and Company, Indianapolis, IN, USA.
authors.forename: L L
authors.initials: LL
authors.lastname: Ilag
authors.affiliation: Eli Lilly and Company, Indianapolis, IN, USA.
authors.forename: W J
authors.initials: WJ
authors.lastname: Huster
authors.affiliation: Eli Lilly and Company, Indianapolis, IN, USA.
authors.forename: J S
authors.initials: JS
authors.lastname: Zielonka
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.
authors.forename: M J
authors.initials: MJ
authors.lastname: Prince
mesh_terms: D000328:Adult; D001786:Blood Glucose / Q000187:drug effects; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination / Q000379:methods; D005260:Female; D006442:Glycated Hemoglobin / Q000187:drug effects; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007330:Insulin Antibodies / Q000097:blood; D000069036:Insulin Glargine / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D061268:Insulin Lispro / Q000008:administration & dosage*; D008297:Male; D062407:Meals; D008875:Middle Aged; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007330:Insulin Antibodies; D000069036:Insulin Glargine; D061268:Insulin Lispro; C000606659:LY2963016 insulin glargine; C517652:hemoglobin A1c protein, human
keywords: LY2963016; insulin glargine; type 1 diabetes