title: Randomized double-blind clinical trial comparing basal insulin peglispro and insulin glargine, in combination with prandial insulin lispro, in patients with type 2 diabetes: IMAGINE 4.
abstract: To evaluate the efficacy and safety of basal insulin peglispro (BIL) with those of insulin glargine, both in combination with prandial insulin lispro, in patients with type 2 diabetes (T2D).
  
  
  
  In this phase III, multicentre, double-blind, 26-week study, we randomized patients with T2D [glycated haemoglobin (HbA1c) ≥7 and <12%, on ≥1 insulin injections daily) to BIL (n = 691) or glargine (n = 678), in combination with lispro.
  
  
  
  At week 26, the primary objective of non-inferiority of BIL versus glargine for HbA1c reduction was achieved (least squares mean difference -0.21%; 95% confidence interval -0.31 to -0.11%), with statistical superiority of BIL with multiplicity adjustment (p < 0.001). HbA1c at baseline was 8.4% versus 8.5% for BIL versus glargine and at 26 weeks it was 6.8% versus 7.0%. At 26 weeks, more patients reached HbA1c <7% with BIL than with glargine (63.3% vs 53.3%; p < 0.001), the nocturnal hypoglycaemia rate (≤3.9 mmol/l) was lower with BIL (0.51 vs 0.92 events/30 days; p < 0.001), but the daytime hypoglycaemia rate was higher with BIL (5.47 vs 4.53 events/30 days; p < 0.001). The total hypoglycaemia relative rate was 1.10 (p = 0.053). At 26 weeks, patients in the BIL group had lower fasting serum glucose levels, higher basal insulin dosing, with no statistically significant difference in prandial or total insulin dosing, reduced glucose variability and less weight gain (1.3 kg vs 2.2 kg) compared with the glargine group. The BIL group had higher mean triglyceride and aminotransferase levels.
  
  
  
  In patients with T2D, BIL with insulin lispro provided greater improvement in glycaemic control with less nocturnal hypoglycaemia, lower glucose variability and less weight gain compared with glargine. The daytime hypoglycaemia rate and mean triglyceride and aminotransferase levels were higher with BIL.
authors.affiliation: Texas Diabetes and Endocrinology, Austin, TX, USA.
authors.forename: T
authors.initials: T
authors.lastname: Blevins
authors.affiliation: Division of Endocrinology and Diabetology, Medical University of Graz, Graz, Austria.
authors.forename: T R
authors.initials: TR
authors.lastname: Pieber
authors.affiliation: American Telemedicine Center, San Juan, Puerto Rico.
authors.forename: G
authors.initials: G
authors.lastname: Colón Vega
authors.affiliation: Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.
authors.forename: S
authors.initials: S
authors.lastname: Zhang
authors.affiliation: Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.|Division of Endocrinology and Metabolism, Indiana University School of Medicine, Indianapolis, IN, USA.
authors.forename: E J
authors.initials: EJ
authors.lastname: Bastyr
authors.affiliation: Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA. chang_anne_m@lilly.com.
authors.forename: A M
authors.initials: AM
authors.lastname: Chang
mesh_terms: D000368:Aged; D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis / Q000187:drug effects; D006801:Humans; D000069036:Insulin Glargine / Q000008:administration & dosage* / Q000009:adverse effects; D061268:Insulin Lispro / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives*; D008297:Male; D062407:Meals; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D000069036:Insulin Glargine; D061268:Insulin Lispro; D011092:Polyethylene Glycols; C000621851:basal insulin peglispro
keywords: basal insulin; glycaemic control; hypoglycaemia; randomized trial; type 2 diabetes