title: Reduced nocturnal hypoglycaemia with basal insulin peglispro compared with insulin glargine: pooled analyses of five randomized controlled trials.
abstract: Basal insulin peglispro (BIL) is a novel basal insulin with hepato-preferential action, resulting from reduced peripheral effects. This report summarizes hypoglycaemia data from five BIL phase III studies with insulin glargine as the comparator, including three double-blind trials. Prespecified pooled analyses (n = 4927) included: patients with type 2 diabetes (T2D) receiving basal insulin only, those with T2D on basal-bolus therapy, and those with type 1 diabetes (T1D). BIL treatment resulted in a 36-45% lower nocturnal hypoglycaemia rate compared with glargine, despite greater reduction in glycated haemoglobin (HbA1c) and higher basal insulin dosing. The total hypoglycaemia rate was similar in patients with T2D on basal treatment only, trended towards being higher (10%) in patients with T2D on basal-bolus treatment (p = .053), and was 15% higher (p < .001) with BIL versus glargine in patients with T1D, with more daytime hypoglycaemia in the T1D and T2D groups who were receiving basal-bolus therapy. In T1D, during the maintenance treatment period (26-52 weeks), the total hypoglycaemia rate was not significantly different. There were no differences in severe hypoglycaemia in the T1D or T2D pooled analyses. BIL versus glargine treatment resulted in greater HbA1c reduction with less nocturnal hypoglycaemia in all patient populations, higher daytime hypoglycaemia with basal-bolus therapy in the T1D and T2D groups, and an associated increase in total hypoglycaemia in the patients with T1D.
authors.affiliation: Dallas Diabetes and Endocrine Center at Medical City, Dallas, Texas, USA.
authors.forename: Julio
authors.initials: J
authors.lastname: Rosenstock
authors.affiliation: Department of Diabetology, Endocrinology and Nutrition, Hopital Bichat Claude Bernard, Paris, France.
authors.forename: Michel
authors.initials: M
authors.lastname: Marre
authors.affiliation: Eli Lilly and Company, Indianapolis, Indiana, USA.
authors.forename: Yongming
authors.initials: Y
authors.lastname: Qu
authors.affiliation: Eli Lilly and Company, Indianapolis, Indiana, USA.
authors.forename: Shuyu
authors.initials: S
authors.lastname: Zhang
authors.affiliation: Eli Lilly and Company, Indianapolis, Indiana, USA.|Division of Endocrinology & Metabolism, Indiana University School of Medicine, Indianapolis, Indiana, USA.
authors.forename: Edward J
authors.initials: EJ
authors.lastname: Bastyr
authors.affiliation: Eli Lilly and Company, Indianapolis, Indiana, USA.
authors.forename: Melvin J
authors.initials: MJ
authors.lastname: Prince
authors.affiliation: Eli Lilly and Company, Indianapolis, Indiana, USA. chang_anne_m@lilly.com.
authors.forename: Annette M
authors.initials: AM
authors.lastname: Chang
mesh_terms: D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism; D002940:Circadian Rhythm / Q000187:drug effects*; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006442:Glycated Hemoglobin / Q000187:drug effects / Q000378:metabolism; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced* / Q000453:epidemiology*; 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*; D012189:Retrospective Studies
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D000069036:Insulin Glargine; D061268:Insulin Lispro; D011092:Polyethylene Glycols; C000621851:basal insulin peglispro
keywords: basal insulin peglispro; hypoglycaemia; insulin glargine; nocturnal hypoglycaemia