Eli Lilly and Company announced positive patient-reported health outcomes from a Phase 3 clinical trial of dulaglutide as a once-weekly treatment for type 2 diabetes. Dulaglutide is an investigational, long-acting glucagon-like peptide 1 (GLP-1) receptor agonist.
AWARD-1 was a randomized, 52-week, placebo-controlled study comparing the effects of dulaglutide and exenatide twice-daily on glycemic control in 978 patients with type 2 diabetes on metformin and pioglitazone. The primary objective of the study was to evaluate superiority of dulaglutide 1.5mg once-weekly, to placebo in reducing HbA1c from baseline at 26 weeks.
Questionnaires were utilized to assess health outcomes at baseline and again prior to follow-up visits at 26 and 52 weeks. Treatment satisfaction, as well as perceived hyperglycemia and hypoglycemia, were measured using the Diabetes Treatment Satisfaction Questionnaire (DTSQ); impact of weight was measured using the Impact of Weight on Self-Perception Questionnaire (IW-SP) and the Ability to Perform Physical Activities of Daily Living Questionnaire (APPADL); and perceived current health status was measured using the EuroQoL 5-Dimension Questionnaire (EQ-5D).
Patient-reported outcomes showed that treatment satisfaction, as measured by the DTSQ, was significantly higher with dulaglutide compared to at baseline. Treatment satisfaction with dulaglutide was significantly greater compared to placebo and exenatide twice-daily at 26 weeks. Significant improvements at 52 weeks compared to baseline were observed with exenatide twice-daily.
Clinical results from the AWARD-1 trial showed that treatment with dulaglutide 1.5mg led to improvements in HbA1c levels and weight reductions. Dulaglutide-treated patients also demonstrated significant improvements compared to baseline and exenatide twice-daily in perceived hyperglycemia scores (using DTSQ) at 26 and 52 weeks.
Patients in the study noted significant improvements in weight-related self-perception (IW-SP) compared to baseline at 26 weeks, which persisted through one year of treatment. These improvements were not significantly different between all treatment groups.
Treatment with dulaglutide, as well as with exenatide twice-daily, led to significant improvements in perceptions of current health status (EQ-5D) compared to baseline at 26 weeks. These mprovements with dulaglutide 1.5mg as well as exenatide twice-daily were also significant compared to placebo. Significant improvements were also seen compared to baseline at one year, with no significant differences between dulaglutide and exenatide twice-daily.
For more information call (800) 545-5979 or visit Lilly.com.