BARCELONA, Spain, Sept. 26, 2013 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced positive patient-reported health outcomes from a Phase III clinical trial of dulaglutide, an investigational, long-acting glucagon-like peptide 1 (GLP-1) receptor agonist being studied as a once-weekly treatment for type 2 diabetes. These results will be presented at the 49th European Association for the Study of Diabetes (EASD) Annual Meeting in Barcelona, Spain.
In addition to reductions in HbA1c (hemoglobin A1c) levels and weight at 26 and 52 weeks with dulaglutide 1.5 mg,[1] dulaglutide-treated patients reported significant, positive improvements compared to baseline across several patient-reported indicators of diabetes management, measured using validated questionnaires, including:
"Patients' perception of how diabetes treatment may affect their lives is an important consideration when choosing a medication. We are pleased that in this study, patients treated with dulaglutide reported improvements in several patient-reported outcome measures," said Gwen Krivi, Ph.D., vice president, Lilly Diabetes product development. "These results, coupled with dulaglutide's positive clinical data, suggest that, if approved, our investigational once-weekly GLP-1 may be an attractive treatment option for patients with type 2 diabetes."
The patient-reported outcomes from the AWARD-1 trial showed that treatment satisfaction, as measured by the DTSQ, was significantly higher with dulaglutide compared to baseline, and was significantly greater compared to placebo and exenatide twice-daily at 26 weeks. Significant improvements were also seen compared to baseline and exenatide twice-daily at 52 weeks.[2]
Clinical results from the AWARD-1 trial showed that treatment with dulaglutide 1.5 mg led to improvements in HbA1c levels and weight reductions.[1] Dulaglutide-treated patients also demonstrated significant improvements compared to baseline and exenatide twice-daily in perceived hyperglycaemia scores (using DTSQ) at 26 and 52 weeks.[2]
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.[2] There were no significant differences in the ability to perform physical activities of daily living (APPADL) between dulaglutide-treated patients compared to baseline, placebo or exenatide-treated patients.[2]
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 improvements with dulaglutide 1.5 mg 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.
In the clinical trial, gastrointestinal-related symptoms, including nausea, vomiting and diarrhoea, were the most common adverse events reported for dulaglutide and were mostly mild to moderate and transient.
Dulaglutide is one of several diabetes molecules in Lilly's late-stage pipeline. The company has a number of potential new medicines in clinical development for the treatment of diabetes and its related conditions. Lilly expects to submit dulaglutide to regulatory authorities in 2013.