title: Achieving the composite endpoint of glycated haemoglobin <7.0%, no weight gain and no hypoglycaemia in the once-weekly dulaglutide AWARD programme.
abstract: OBJECTIVE
  To compare the effectiveness of dulaglutide 1.5 and 0.75 mg with active comparators and placebo with regard to a composite endpoint of glycated haemoglobin (HbA1c), weight and hypoglycaemia, using post hoc analyses.
  
  
  METHODS
  A logistic regression analysis was performed on the intention-to-treat population, using data from the last observation carried forward, and the composite endpoint of HbA1c <7.0% (53 mmol/mol), no weight gain (≤0 kg) and no hypoglycaemia (glucose <3.0 mmol/l or severe hypoglycaemia) after 26 weeks for each trial in the AWARD programme separately.
  
  
  RESULTS
  At 26 weeks, within each study, 37-58% of patients on dulaglutide 1.5 mg, 27-49% of patients on dulaglutide 0.75 mg, and 9-61% of patients on active comparators achieved the composite endpoint. Significantly more patients reached the composite endpoint with dulaglutide 1.5 mg than with metformin, sitagliptin, exenatide twice daily or insulin glargine: odds ratio (OR) 1.5 [95% confidence interval (CI) 1.0, 2.2; p < 0.05], OR 4.5 (95% CI 3.0, 6.6; p < 0.001), OR 2.6 (95% CI 1.8, 3.7; p < 0.001) and OR 7.4 (95% CI 4.4, 12.6; p < 0.001), respectively, with no difference between dulaglutide 1.5 mg and liraglutide 1.8 mg. In addition, significantly more patients reached the composite endpoint with dulaglutide 0.75 mg than with sitagliptin or insulin glargine: OR 3.3 (95% CI 2.2, 4.8; p < 0.001) and OR 4.5 (95% CI 2.7, 7.8; p < 0.001), respectively.
  
  
  CONCLUSIONS
  Dulaglutide is an effective treatment option, resulting in a similar or greater proportion of patients reaching the HbA1c target of <7.0% (53 mmol/mol), without weight gain or hypoglycaemia compared with active comparators.
authors.affiliation: Division of Endocrinology, Diabetes and Metabolism, Ohio State University, Columbus, OH, USA.
authors.forename: K M
authors.initials: KM
authors.lastname: Dungan
authors.affiliation: Hadassah Hebrew University Hospital, Jerusalem, Israel.
authors.forename: I
authors.initials: I
authors.lastname: Raz
authors.affiliation: Eli Lilly and Company, Indianapolis, IN, USA.
authors.forename: Z
authors.initials: Z
authors.lastname: Skrivanek
authors.affiliation: Eli Lilly and Company, Indianapolis, IN, USA.
authors.forename: W
authors.initials: W
authors.lastname: Sealls
authors.affiliation: Eli Lilly and Company, Indianapolis, IN, USA.
authors.forename: J L
authors.initials: JL
authors.lastname: Fahrbach
mesh_terms: D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D004334:Drug Administration Schedule; D000077270:Exenatide; D005260:Female; D004763:Glucagon-Like Peptides / Q000008:administration & dosage / Q000031:analogs & derivatives*; D006442:Glycated Hemoglobin / Q000032:analysis / Q000187:drug effects*; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007141:Immunoglobulin Fc Fragments / Q000008:administration & dosage*; D000069450:Liraglutide / Q000008:administration & dosage; D008297:Male; D008687:Metformin / Q000008:administration & dosage; D008875:Middle Aged; D010455:Peptides / Q000008:administration & dosage; D016032:Randomized Controlled Trials as Topic; D011993:Recombinant Fusion Proteins / Q000008:administration & dosage*; D000068900:Sitagliptin Phosphate / Q000008:administration & dosage; D016896:Treatment Outcome; D014688:Venoms / Q000008:administration & dosage; D015430:Weight Gain / Q000187:drug effects*
chemical_list: D000077270:Exenatide; D004763:Glucagon-Like Peptides; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007141:Immunoglobulin Fc Fragments; D000069450:Liraglutide; D008687:Metformin; D010455:Peptides; D011993:Recombinant Fusion Proteins; D000068900:Sitagliptin Phosphate; D014688:Venoms; C517652:hemoglobin A1c protein, human; C555680:dulaglutide
keywords: GLP-1 analogue; composite endpoint; dulaglutide