title: Basal insulin peglispro versus insulin glargine in insulin-naïve type 2 diabetes: IMAGINE 2 randomized trial.
abstract: To compare, in a double-blind, randomized, multi-national study, 52- or 78-week treatment with basal insulin peglispro or insulin glargine, added to pre-study oral antihyperglycaemic medications, in insulin-naïve adults with type 2 diabetes.
  
  
  
  The primary outcome was non-inferiority of peglispro to glargine with regard to glycated haemoglobin (HbA1c) reduction (margin = 0.4%). Six gated secondary objectives with statistical multiplicity adjustments focused on other measures of glycaemic control and safety. Liver fat content was measured using MRI, in a subset of patients.
  
  
  
  Peglispro was non-inferior to glargine in HbA1c reduction [least-squares (LS) mean difference: -0.29%, 95% confidence interval (CI) -0.40, -0.19], and had a lower nocturnal hypoglycaemia rate [relative rate 0.74 (95% CI 0.60, 0.91); p = .005), more patients achieving HbA1c <7.0% without nocturnal hypoglycaemia [odds ratio (OR) 2.15 (95% CI 1.60, 2.89); p < .001], greater HbA1c reduction (p < .001), and more patients achieving HbA1c<7.0% [OR 1.97 (95% CI 1.57, 2.47); p < .001]. Total hypoglycaemia rate and fasting serum glucose did not achieve statistical superiority. At 52 weeks, peglispro-treated patients had higher triglyceride (1.9 vs 1.7 mmol/L). alanine transaminase (34 vs 27 IU/L), and aspartate transaminase levels (27 vs 24 IU/L). LS mean liver fat content was unchanged with peglispro at 52 weeks but decreased 3.1% with glargine [difference: 2.6% (0.9, 4.2); p = .002]. More peglispro-treated patients experienced adverse injection site reactions (3.5% vs 0.6%, p < .001).
  
  
  
  Compared with glargine at 52 weeks, peglispro resulted in a statistically superior reduction in HbA1c, more patients achieving HbA1c targets, less nocturnal hypoglycaemia, no improvement in total hypoglycaemia, higher triglyceride levels, higher aminotransferase levels, and more injection site reactions.
authors.affiliation: Department of Health Sciences, Diabetes Research Centre, University of Leicester, Leicester, UK.
authors.forename: M J
authors.initials: MJ
authors.lastname: Davies
authors.affiliation: Department of Endocrinology and Diabetes, Royal Surrey County Hospital, Guildford, UK.
authors.forename: D
authors.initials: D
authors.lastname: Russell-Jones
authors.affiliation: Diabetes Research Center, Tustin, California.
authors.forename: J-L
authors.initials: JL
authors.lastname: Selam
authors.affiliation: AMCR Institute, Escondido, California.
authors.forename: T S
authors.initials: TS
authors.lastname: Bailey
authors.affiliation: Csepel Health Service, Budapest, Hungary.
authors.forename: Z
authors.initials: Z
authors.lastname: Kerényi
authors.affiliation: Eli Lilly and Company, Indianapolis, Indiana.
authors.forename: J
authors.initials: J
authors.lastname: Luo
authors.affiliation: Eli Lilly and Company, Indianapolis, Indiana.
authors.forename: J
authors.initials: J
authors.lastname: Bue-Valleskey
authors.affiliation: Eli Lilly and Company, Budapest, Hungary.
authors.forename: T
authors.initials: T
authors.lastname: Iványi
authors.affiliation: Eli Lilly and Company, Indianapolis, Indiana.
authors.forename: M L
authors.initials: ML
authors.lastname: Hartman
authors.affiliation: Eli Lilly and Company, Indianapolis, Indiana.
authors.forename: J G
authors.initials: JG
authors.lastname: Jacobson
authors.affiliation: Eli Lilly and Company, Indianapolis, Indiana. sjacober@lilly.com.
authors.forename: S J
authors.initials: SJ
authors.lastname: Jacober
mesh_terms: D000284:Administration, Oral; D000368:Aged; D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism; D002940:Circadian Rhythm; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005215:Fasting / Q000097:blood; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000069036:Insulin Glargine / Q000008:administration & dosage* / Q000009:adverse effects; D061268:Insulin Lispro / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D061268:Insulin Lispro; C000621851:basal insulin peglispro; D000069036:Insulin Glargine; D011092:Polyethylene Glycols
keywords: 
  BIL
  ; basal insulin peglispro; insulin therapy; insulin-naïve; type 2 diabetes