AWARD-11 phase III of Trulicity meets endpoints in type 2 diabetes

Eli Lilly's AWARD-11 phase III randomized, double-blind, parallel arm study investigating higher investigational doses of Trulicity (dulaglutide) met its primary efficacy endpoint of superiority, significantly reducing A1C from baseline in people with type 2 diabetes, compared to once-weekly Trulicity 1.5 mg after 36 weeks. The trial also met the secondary efficacy endpoint for superiority on weight reduction. The safety and tolerability profile of the investigational dulaglutide doses was consistent with the known profile of Trulicity 1.5 mg.

This study evaluated the safety and efficacy of dulaglutide 3.0 mg and 4.5 mg doses in 1,842 participants with type 2 diabetes. The AWARD-11 trial will continue through 52 weeks to evaluate longer-term safety data and is expected to complete in late 2019. Lilly plans to submit to regulatory authorities by late 2019 and will share detailed results at a future date.

Comment: There are six GLP-1 agonists already approved by the FDA including Trulicity, Novo Nordisk's Victoza and AstraZeneca's Byetta. Trulicity has advanced better than its competitors, and last year, it passed Victoza to take the lead in weekly total prescriptions among GLP-1 medicines in the US.