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ARTICLE | Clinical News

Dulaglutide: Additional Phase III data

July 1, 2013 7:00 AM UTC

Additional data from the double-blind, international Phase III AWARD-1 trial in 978 Type II diabetics on metformin and pioglitazone showed that once-weekly 0.75 mg dulaglutide reduced mean HbA1c from baseline to week 26, the primary endpoint, by 1.3% and once-weekly 1.5 mg dulaglutide reduced mean HbA1c from baseline to week 26 by 1.51% vs. 0.46% for placebo (p<0.001 for both). Both doses of dulaglutide also led to a significantly greater reduction on the endpoint compared to twice-daily 5 µg Byetta exenatide (0.99%, 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 26 (65.8% and 78.2%, respectively) vs. both placebo (42.9%, p<0.001 for both) and Byetta (52.3%, p<0.001 for both). Mean weight change from baseline to week 26 was an increase of 0.2 kg for low-dose dulaglutide, a reduction of 1.3 kg for high-dose dulaglutide, an increase of 1.24 kg for placebo and a reduction of 1.07 kg for Byetta.

At week 52, low- and high-dose dulaglutide both significantly reduced mean HbA1c from baseline vs. Byetta (1.07% and 1.36%, respectively, vs. 0.8%, 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. Byetta (59.1% and 70.8%, respectively, vs. 49.2%, p<0.05 for both). Mean weight change from baseline to week 52 was an increase of 0.54 kg for low-dose dulaglutide, a reduction of 1.01 kg for high-dose dulaglutide and a reduction of 0.71 kg for Byetta. Both doses of dulaglutide also significantly improved total Diabetes Treatment Satisfaction Questionnaire (DTSQ) scores and DTSQ hyperglycemia scores from baseline to weeks 26 and 52 vs. Byetta (p<0.05 for all). Data were presented at the American Diabetes Association meeting in Chicago. ...