Lilly’s GLP-1 matches Victoza

Lilly's phase III diabetes treatment dulaglutide has matched Victoza in a head-to-head trial, which will help it make in-roads into the fiercely competitive market.

Top-line results of the AWARD-6 trial for once-weekly dulaglutide, a long-acting glucagon-like peptide 1 (GLP-1) were positive for the company. Lilly's drug proved itself equal to Victoza (liraglutide) in the study, a non-inferiority trial of once-weekly dulaglutide 1.5 mg versus a once-daily liraglutide 1.8 mg in reducing blood sugar levels.

Dulaglutide is a once-weekly injection compared to the daily injections of Victoza, which should make it attractive to patients and doctors.

"Dulaglutide is the only GLP-1 agonist to show non-inferiority against liraglutide's highest-approved dose in a Phase III trial," said Enrique Conterno, president of Lilly Diabetes. "The AWARD-6 data, along with the previous five AWARD studies, give us confidence that dulaglutide can be an important treatment option for people with type 2 diabetes. If approved, dulaglutide would be the only GLP-1 agonist that is both once-weekly and ready-to-use."

The drug has already submitted to the FDA, the EMA and other regulators, and could hit the market later this year.

Lilly says all previous five AWARD trials (1-5) included demonstrated superiority in reduction of HbA1c at the 1.5 mg dose against placebo and active comparators, and the firm has a number of other major data announcements to make.

Lilly plans to present detailed data later this year. In AWARD-2, where it is up against market leading insulin product Lantus (insulin glargine), and AWARD-4 (dulaglutide vs. insulin glargine; both in combination with insulin lispro).

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