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Eli Lilly Phase II type 2 diabetes study meets primary endpoint

Eli Lilly and Company has reported Phase II blood pressure and heart rate data on investigational GLP-1 analog candidate, Dulaglutide, in patients with type 2 diabetes.

Dulaglutide, a long-acting glucagon-like peptide 1 (GLP-1) analog, met its primary endpoint of non-inferiority for mean 24-hour systolic blood pressure (SBP, or pressure while the heart contracts) after 16 weeks.

The study compared two doses of dulaglutide to placebo, using ambulatory blood pressure monitoring (ABPM) to characterize changes in blood pressure and heart rate.

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.

In addition, the 1.5mg dulaglutide dose significantly reduced mean 24-hour SBP compared to placebo.

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.