Dulaglutide: Additional Phase III data

Additional data from the double-blind, placebo-controlled, international Phase III AWARD-5 trial in 1,098 Type II diabetics on metformin showed that once-weekly 0.75 mg dulaglutide reduced mean HbA1c from baseline to week 52, the primary endpoint, by 0.86% and once-weekly 1.5 mg dulaglutide reduced mean HbA1c from baseline to week 52 by 1.11% vs. 0.39% for Januvia sitagliptin (p<0.001 for both). Additionally, a significantly greater proportion of patients receiving low- and high-dose dulaglutide achieved an HbA1c of <7% at week 52 vs. Januvia (48.8% and 57.6%, respectively, vs. 33%, p<0.001 for both). Mean weight change from baseline to week 52 was a reduction of 2.6 kg for low-dose dulaglutide, a reduction of 3.03 kg for high-dose dulaglutide and a reduction of 1.53 kg for Januvia.

At week 104, low- and high-dose dulaglutide both significantly reduced mean HbA1c from baseline vs. Januvia (0.71% and 1%, respectively, vs. 0.32%, p<0.001 for both). Additionally, a significantly greater proportion of patients receiving low- and high-dose dulaglutide achieved an HbA1c of <7% at week 104 vs. Januvia (44.8% and 54.3%, respectively, vs. 31.1%, p<0.001 for both). Mean weight change from baseline to week 104 was a reduction of 2.39 kg for low-dose dulaglutide, a reduction of 2.88 kg for high-dose dulaglutide and a reduction of 1.75 kg for Januvia. Data were presented at the American Diabetes Association meeting in Chicago. ...