PIII AWARD-11 trial in 1852 patients with type 2 diabetes inadequately controlled by metformin found dose escalation of dulaglutide from 1.5 mg to 3.0 mg or 4.5 mg once weekly provided improved glycaemic control and body weight reduction vs. 1.5 mg at 36 weeks, with a similar safety .
New 36-week data from AWARD-11 trial show HbA1c and weight reduction was greater with 4.5 mg dose (-1.9% and -4.7kg, -1.7% and -4.0 kg, and -1.5% and -3.1kg for 4.5, 3, and 1.5 mg doses respectively) .
Topline data from AWARD-11 trial showed that the higher dose of Trulicity reached its primary endpoint of significantly reducing HbA1C from baseline vs. a once-a-week dose of Trulicity. At 36 weeks, pts receiving higher doses had better HbA1C reduction and also better weight reduction.
PIII AWARD-11 trial to evaluate the safety and efficacy of three doses of once weekly dulaglutide (1.5mg, 3mg and 4.5mg) in patients with type-2 diabetes on metformin starts (NCT03495102). The trial is designed to enrol approximately 1,800 patients in the US, Puerto Rico, Romania, Poland, Mexico, Taiwan, Spain, Slovakia, Russia, Italy, Israel, Hungary, Greece, Canada, Austria and Argentina. Collection of primary outcome data is due to complete May 19 .