BioCentury
ARTICLE | Clinical News

Albiglutide: Phase III data

July 1, 2013 7:00 AM UTC

The double-blind, international Phase III Harmony 3 trial in 999 Type II diabetics who were inadequately controlled on metformin showed that once-weekly subcutaneous 30 mg albiglutide plus metformin met the primary endpoint of reducing HbA1c from baseline to week 104 vs. Januvia sitagliptin plus metformin (treatment difference of 0.4%, p=0.0001), glimepiride plus metformin (treatment difference of 0.3%, p=0.003) and placebo plus metformin (treatment difference of 0.9%, p<0.0001). On secondary endpoints, albiglutide significantly reduced FPG compared to Januvia (treatment difference of 15.5 mg/dL, p<0.05), glimepiride (treatment difference of 10.1 mg/dL, p<0.05) and placebo (treatment difference of 27.7 mg/dL, p<0.05). Albiglutide also significantly improved weight loss vs. glimepiride (treatment difference of 2.4 kg, p<0.0001), but led to a non-significant improvement on the endpoint compared to Januvia (treatment difference of 0.4 kg) and placebo (treatment difference of 0.2 kg). The most common adverse events were injection-site reactions and gastrointestinal complaints of primarily nausea and diarrhea. Data were presented at the American Diabetes Association meeting in Chicago. A BLA is under FDA review and an MAA is under EMA review for albiglutide to treat Type II diabetes. ...