Safety and efficacy of once-weekly dulaglutide versus sitagliptin after 2 years in metformin-treated patients with type 2 diabetes (AWARD-5): a randomized, phase III study

• Published in: Diabetes, obesity & metabolism obesity & metabolism, 2015-09, Vol.17 (9), p.849-858
• Main Authors: Weinstock, R. S., Guerci, B., Umpierrez, G., Nauck, M. A., Skrivanek, Z., Milicevic, Z.
• Format: Article
• Language: English
• Subjects: Blood Glucose - drug effects; diabetes; Diabetes Mellitus, Type 2 - blood; Diabetes Mellitus, Type 2 - drug therapy; Double-Blind Method; Drug Administration Schedule; Drug Therapy, Combination - methods; dulaglutide; Female; Glucagon-Like Peptides - administration & dosage; Glucagon-Like Peptides - analogs & derivatives; Glycated Hemoglobin A - drug effects; Humans; Hypoglycemic Agents - administration & dosage; Immunoglobulin Fc Fragments - administration & dosage; Male; Metformin - administration & dosage; Middle Aged; Original; Recombinant Fusion Proteins - administration & dosage; sitagliptin; Sitagliptin Phosphate - administration & dosage; Treatment Outcome; Weight Loss - drug effects
• ISSN: 1462-8902; 1463-1326
• DOI: 10.1111/dom.12479

Aims To compare the once‐weekly glucagon‐like peptide‐1 (GLP‐1) receptor dulaglutide with the dipeptidyl peptidase‐4 (DPP‐4) inhibitor sitagliptin after 104 weeks of treatment. Methods This AWARD‐5 study was a multicentre, double‐blind trial that randomized participants to dulaglutide (1.5 or 0.75 mg) or sitagliptin 100 mg for 104 weeks or placebo (reported separately) for 26 weeks. Change in glycated haemoglobin (HbA1c) concentration from baseline was the primary efficacy measure. A total of 1098 participants with HbA1c concentrations ≥7.0% (≥53.0 mmol/mol) and ≤9.5% (≤80.3 mmol/mol) were randomized, and 657 (59.8%) completed the study. We report results for dulaglutide and sitagliptin at the final endpoint. Results Changes in HbA1c at 104 weeks were (least squares mean ± standard error) −0.99 ± 0.06% (−10.82 ± 0.66 mmol/mol), −0.71 ± 0.07% (−7.76 ± 0.77 mmol/mol) and −0.32 ± 0.06% (−3.50 ± 0.66 mmol/mol) for dulaglutide 1.5 mg, dulaglutide 0.75 mg and sitagliptin, respectively (p