Eli Lilly has reported positive data from its investigational, long-acting glucagon-like peptide 1 (GLP-1) analog dulaglutide, from the Phase 2 study conducted in patients with type 2 diabetes.
The Phase 2 study was a 26-week, randomised, double-blind, placebo-controlled, parallel trial that included 755 patients with type 2 diabetes on one or more oral diabetes medications.
The trial was designed to determine whether changes from baseline to week 16 in mean 24-hour systolic blood pressure (SBP) of dulaglutide 0.75mg and dulaglutide 1.5mg, dosed once-weekly, were non-inferior (NI) to placebo, as measured by ambulatory blood pressure monitoring (ABPM).
Both dulaglutide doses were shown to be NI (margin 3mmHg), which was the primary objective of the study, and also demonstrated reductions in HbA1c (average blood glucose levels over a three-month period) from baseline, compared to placebo, at weeks 16 and 26.
In addition, the 1.5mg dulaglutide dose considerably reduced mean 24-hour SBP compared to placebo.
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The study also evaluated several secondary objectives, including effects on mean 24-hour diastolic blood pressure (DBP) and mean 24-hour heart rate.
For mean 24-hour DBP, NI criterion (2.5mmHg) was met for both dulaglutide doses, compared to placebo at weeks 16 and 26.
ABPM is a non-invasive, fully automated technique to measure blood pressure at specific intervals (usually every 15-30 minutes) throughout an entire 24-hour period, enabling clinicians to accurately characterise a person’s blood pressure levels.
Lilly diabetes product development vice president, Gwen Krivi, said dulaglutide is currently in Phase 3 clinical trials, where it will continue to be evaluated on its efficacy to lower blood glucose levels, overall safety, weight effects and effects on cardiovascular outcomes.
"We believe dulaglutide, if approved, can bring significant benefits to people with type 2 diabetes," Krivi added.
Image: Eli Lilly and Company’s global headquarters, in Indianapolis, Indiana, US. Photo courtesy of: Guanaco152003.