Eli Lilly has presented promising mid-stage data on its investigational diabetes drug dulaglutide which confirmed the treatment's cardiovascular safety profile.
In data presented at the annual scientific meeting of the American Society of Hypertension in New York, dulaglutide, Lilly's once-weekly glucagon-like peptide 1 (GLP-1) analogue met its primary endpoint of non-inferiority for mean 24-hour systolic blood pressure (SBP) after 16 weeks. The results came from a 755-patient Phase II study that compared two doses of dulaglutide to placebo, using ambulatory blood pressure monitoring (ABPM) to check changes in blood pressure and heart rate.
The results also revealed that the 1.5mg dose of dulaglutide significantly reduced mean 24-hour SBP compared to placebo. Lilly also noted that both doses of dulaglutide (ie 1.5mg and 0.75mg) demonstrated statistically significant reductions in HbA1c (average blood glucose levels over a three-month period) compared to placebo, at weeks 16 and 26.
Gwen Krivi, head of product development at Lilly Diabetes, said that "we are very encouraged by these clinical trial results, in addition to the rest of the clinical trial data we've seen to date for dulaglutide". The drug, which is in Phase III, could compete with Amylin's Bydureon (extended-release exenatide), a drug which Lilly played a major part in developing before recently ending its long-term collaboration with Amylin.