Patient-Reported Outcomes of Dulaglutide

Patients assigned to the glucagon-like peptide (GLP)-1 receptor agonist dulaglutide reported improvements in several patient-reported outcomes (PROs), including weight-related outcomes, according to data taken from the AWARD phase III trials.

“Since most type 2 diabetes patients struggle with weight management, having weight-related PRO results that remained stable or favorable can be viewed as beneficial when evaluating treatment options,” wrote researcher Maria Yu, of Eli Lilly and Company, Toronto, Canada, and colleagues in Diabetes Obesity and Metabolism.

Yu and colleagues conducted an analysis of PROs taken from six AWARD trials, which evaluated weekly administration of dulaglutide in patients with diabetes. In these trials, dulaglutide was compared with oral antihyperglycemic medications such as metformin or sitagliptin, insulin, or other GLP-1 receptor agonists. PROs were measured using a series of tools including: Impact of Weight on Self-Perception (IWSP), Ability to Perform Physical Activities of Daily Living (APPADL), Adult Low Blood Sugar Survey (ALBSS), and the Diabetes Treatment Satisfaction Questionnaire including status/change versions (DTSQs/c).

In AWARD-3, which compared dulaglutide with metformin, patients assigned dulaglutide 1.5 mg had a significantly greater decrease for the DTSQs Hyperglycemia subscale compared with patients assigned metformin (P=0.016). In the AWARD-1 trial, which compared dulaglutide 1.5 mg and 0.75 mg with exenatide, dulaglutide demonstrated significant improvements in the DTSQs total score (P<0.001), hyperglycemia subscale (P<0.001), and hypoglycemia subscale (P<0.012) compared with exenatide.

“Dulaglutide-treated patients perceived less hyperglycaemia in comparison to metformin treated patients, which is consistent with greater HbA1c reductions observed for both dulaglutide doses at the primary endpoint,” the researchers wrote. “Additionally, dulaglutide-treated patients had greater treatment satisfaction and perceived less hyperglycaemia in comparison to exenatide-treated patients, consistent with the observed differences between arms in glycaemic control.”

In AWARD-2, which compared dulaglutide 1.5 mg with insulin glargine, patients assigned the GLP-1 receptor agonist had significantly improved APPADL (P<0.001) compared with insulin glargine. In addition, patients assigned to dulaglutide 1.5 mg had significant improvements for the ALBSS total scores compared with patients assigned insulin glargine (P=0.003).

Similarly, in AWARD-4, which compared dulaglutide with insulin glargine, patients assigned to dulaglutide 1.5 mg had significant improvements for the IW-SP compared with patients assigned insulin glargine (P=0.0392).

No differences were found for PRO measures in AWARD-5 (dulaglutide compared with sitagliptin) or AWARD-6 (dulaglutide 1.5 mg compared with liraglutide 1.8 mg).

“Consistent with the clinical results, the PRO results reported here suggest that dulaglutide treatment as monotherapy and as combination therapy may provide clinical benefits relevant to patients with varying degrees of type 2 diabetes and improve patients’ perceptions of their diabetes and associated treatment,” the researchers wrote.

This study was sponsored by Eli Lilly and Company.

Reference: Yu M, et al. Patient-reported outcome results in patients with type 2 diabetes treated with once weekly dulaglutide: data from the AWARD Phase 3 clinical trial programme. Diabetes Obes Metab. Epub 22 Dec 2015.