What do we already know about this topic?

• Dulaglutide is approved at 2 doses (0.75 and 1.5 mg) for treatment of type 2 diabetes (T2D).
• The purpose of AWARD-11 (NCT03495102) is to evaluate the efficacy and safety of investigational doses of once weekly dulaglutide when added to metformin in participants with T2D with inadequate blood glucose control.

How was this study conducted?

• In this phase 3 study, once weekly dulaglutide 3 mg and 4.5 mg were compared to dulaglutide 1.5 mg for efficacy and safety through 52 weeks (primary endpoint at 36 weeks) in patients with inadequately controlled T2D on metformin therapy.
• Patients were randomized (1:1:1) to once weekly dulaglutide 1.5 mg (n=612), dulaglutide 3 mg (n=616), and dulaglutide 4.5 mg (n=614).
• All patients were initiated on once weekly dulaglutide 0.75 mg for 4 weeks, followed by step-wise dose escalation every 4 weeks to the randomized dose of 1.5 mg, 3 mg, or 4.5 mg.
• Efficacy measures were analyzed based on data on-treatment without initiation of rescue medication.