title: Once-weekly glucagon-like peptide-1 receptor agonist dulaglutide significantly decreases glycated haemoglobin compared with once-daily liraglutide in Japanese patients with type 2 diabetes: 52 weeks of treatment in a randomized phase III study.
abstract: OBJECTIVE
  To examine the efficacy and safety of once-weekly dulaglutide 0.75 mg monotherapy compared with once-daily liraglutide 0.9 mg in Japanese patients with type 2 diabetes (T2D) for 52 weeks.
  
  
  METHODS
  We conducted a phase III, randomized, 52-week (26-week primary endpoint), active- and placebo-controlled trial comparing 492 Japanese patients (dulaglutide, n = 281; liraglutide, n = 141; and placebo, n = 70). Participants and investigators were blinded to treatment assignment for dulaglutide and placebo but not for liraglutide (open-label comparator); after 26 weeks, patients randomized to placebo were switched to once-weekly dulaglutide 0.75 mg (open-label). The present paper reports results for patients treated with dulaglutide and patients treated with liraglutide for 52 weeks.
  
  
  RESULTS
  At week 52, dulaglutide decreased HbA1c significantly from baseline compared with liraglutide [least squares mean difference: -0.20; 95% confidence interval (CI) -0.39, -0.01; p = 0.04]. At week 52 (last observation carried forward), dulaglutide significantly decreased pre- and post-dinner blood glucose (BG) levels, the mean of seven-point self-monitored BG profiles, the mean of all postprandial BG levels and circadian variation compared with liraglutide. Body weight was generally stable in both groups through 52 weeks. The most frequently reported adverse events were nasopharyngitis, constipation, nausea and diarrhoea. Eight dulaglutide-treated (2.9%) and four liraglutide-treated (2.9%) patients reported hypoglycaemia, with no event being severe.
  
  
  CONCLUSIONS
  Monotherapy with once-weekly dulaglutide 0.75 mg was effective and safe in Japanese patients with T2D, with better glycaemic control compared with once-daily liraglutide 0.9 mg.
authors.affiliation: Division of Diabetes, Endocrinology and Metabolism, Department of Diabetes, Endocrinology, Metabolism and Rheumatology, Tokyo Medical University, Tokyo, Japan.
authors.forename: M
authors.initials: M
authors.lastname: Odawara
authors.affiliation: Division of Diabetes, Endocrinology and Metabolism, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan.
authors.forename: J
authors.initials: J
authors.lastname: Miyagawa
authors.affiliation: Eli Lilly Japan K.K., Kobe, Japan.
authors.forename: N
authors.initials: N
authors.lastname: Iwamoto
authors.affiliation: Eli Lilly Japan K.K., Kobe, Japan.
authors.forename: Y
authors.initials: Y
authors.lastname: Takita
authors.affiliation: Eli Lilly Japan K.K., Kobe, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Imaoka
authors.affiliation: Department of Comprehensive Metabology, Kanazawa University Graduate School of Medical Sciences, Kanazawa, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Takamura
mesh_terms: D000368:Aged; D001786:Blood Glucose; D001835:Body Weight / Q000187:drug effects; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D004763:Glucagon-Like Peptides / Q000008:administration & dosage / Q000031:analogs & derivatives*; D006442:Glycated Hemoglobin / Q000187:drug effects*; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007141:Immunoglobulin Fc Fragments / Q000008:administration & dosage*; D007564:Japan; D000069450:Liraglutide / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D019518:Postprandial Period / Q000187:drug effects; D011993:Recombinant Fusion Proteins / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D004763:Glucagon-Like Peptides; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007141:Immunoglobulin Fc Fragments; D000069450:Liraglutide; D011993:Recombinant Fusion Proteins; C517652:hemoglobin A1c protein, human; C555680:dulaglutide
keywords: GLP-1 receptor agonist; dulaglutide; liraglutide; type 2 diabetes