Efficacy and safety of dulaglutide in the treatment of type 2 diabetes: a comprehensive review of the dulaglutide clinical data focusing on the AWARD phase 3 clinical trial program
2016
Summary
Dulaglutide(DU) is a once weekly
glucagon-like peptide-1 receptoragonist (GLP-1 RA) approved for the treatment of type 2 diabetes mellitus (T2DM). Glycaemic efficacy and safety characteristics of
dulaglutidehave been assessed in six Phase 3 studies in the AWARD program. The objective of this review article is to summarize these results from the six completed AWARD studies. At the primary endpoint, in five of the six studies, once weekly
dulaglutide1.5 mg was superior to the active comparator [
exenatide,
insulin glargine(two studies), metformin, and
sitagliptin], with a greater proportion of patients reaching
glycated hemoglobinA1c (HbA1c) targets of <7.0% (53.0 mmol/mol) and ≤6.5% (47.5 mmol/mol).
Dulaglutide1.5 mg was non-inferior to
liraglutidein AWARD-6. Once weekly
dulaglutide0.75 mg was evaluated in five of these trials and demonstrated superiority to the active comparator in four of five AWARD studies (
exenatide, glargine, metformin, and
sitagliptin), and non-inferiority to glargine in the AWARD-2 study. Similar to other GLP-1 receptor agonists, treatment with
dulaglutidewas associated with weight loss or attenuation of weight gain and low rates of hypoglycaemia when used alone or with non-insulin-
secretagoguetherapy. The most frequently reported adverse events were gastrointestinal, including nausea, vomiting, and diarrhea. The incidence of
dulaglutideantidrug antibody formation was 1–2.8% with rare
injection site reactions. In conclusion,
dulaglutideis an effective treatment for T2DM and has an acceptable tolerability and safety profile. Copyright © 2016 John Wiley & Sons, Ltd.
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