BioCentury
ARTICLE | Clinical News

Dulaglutide: Additional Phase III data

June 23, 2014 7:00 AM UTC

Additional data from the open-label, international Phase III AWARD-2 trial in 807 Type II diabetics on metformin and glimepiride showed that once-weekly 1.5 mg subcutaneous dulaglutide was superior to Lantus insulin glargine in reducing HbA1c from baseline to week 52 (1.08% vs. 0.63%, p<0.001 for superiority) and to week 78 (0.9% vs. 0.59%, p<0.001 for superiority). Additionally, once-weekly 0.75 mg dulaglutide was non-inferior, but not superior to Lantus in reducing HbA1c from baseline to week 52 (0.76% vs. 0.63%, p<0.001 for non-inferiority) and to week 78 (0.62% vs. 0.59%, p<0.001 for non-inferiority). On a secondary endpoint at week 52, dulaglutide significantly reduced weight from baseline by 1.33 kg at the low dose and by 1.87 kg at the high dose vs. an increase of 1.44 kg for Lantus (p<0.05 for both). At week 78, dulaglutide significantly reduced weight from baseline by 1.54 kg at the low dose and by 1.96 kg at the high dose vs. an increase of 1.28 kg for Lantus (p<0.05 for both).

Additionally, a significantly greater proportion of patients receiving high-dose dulaglutide achieved an HbA1c of <7% at week 52 (53.2% vs. 30.9%, p<0.05) and at week 78 (49% vs. 30.5%, p<0.05) vs. Lantus. Low-dose dulaglutide non-significantly increased the proportion of patients achieving an HbA1c of <7% at week 52 (37.1% vs. 30.9%) and at week 78 (34.1% vs. 30.5%) vs. Lantus. Both doses of dulaglutide led to a lower rate of hypoglycemia at week 78 vs. Lantus (1.7 events/patient/year for both doses vs. 3 events/patient/year for Lantus). Data were presented at the American Diabetes Association meeting in San Francisco. Eli Lilly previously reported top-line data from AWARD-2 showing that 1.5 mg dulaglutide met the primary endpoint of non-inferiority to Lantus in reducing HbA1c from baseline to week 52 and also showed superiority over Lantus plus Humalog on the measure (see BioCentury, April 22, 2013). ...