Dulaglutide: Additional Phase III data

Additional data from the double-blind, international Phase III AWARD-3 trial in 807 patients with early Type II diabetes showed that once-weekly 0.75 mg dulaglutide reduced mean HbA1c from baseline to week 26, the primary endpoint, by 0.71% and once-weekly 1.5 mg dulaglutide reduced mean HbA1c from baseline to week 26 by 0.78% vs. 0.56% for metformin (p<0.025 for both for superiority). Additionally, a significantly greater proportion of patients receiving low- and high-dose dulaglutide achieved an HbA1c of <7% at week 26 vs. metformin (62.6% and 61.5%, respectively, vs. 53.6%, p<0.05 for both). Mean weight change from baseline to week 26 was a reduction of 1.36 kg for low-dose dulaglutide, a reduction of 2.29 kg for high-dose dulaglutide and a reduction of 2.22 kg for metformin.

At week 52, low-dose dulaglutide led to a non-inferior reduction in mean HbA1c from baseline vs. metformin (0.55% vs. 0.51%, p<0.025 for non-inferiority), while high-dose dulaglutide significantly reduced mean HbA1c from baseline to week 52 vs. metformin (0.7%, p<0.025 for superiority). Additionally, a significantly greater proportion of patients receiving high-dose dulaglutide achieved an HbA1c of <7% at week 52 vs. metformin (60% vs. 48.3%, p<0.05). Mean weight change from baseline to week 52 was a reduction of 1.09 kg for low-dose dulaglutide, a reduction of 1.93 kg for high-dose dulaglutide and a reduction of 2.2 kg for metformin. Both doses of dulaglutide also significantly improved total Diabetes Treatment Satisfaction Questionnaire (DTSQ) hyperglycemia scores from baseline to week 52 vs. metformin (p<0.05 for both). Data were presented at the American Diabetes Association meeting in Chicago. ...