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ARTICLE | Clinical News

Albiglutide: Phase III data

July 1, 2013 7:00 AM UTC

The double-blind, international Phase III Harmony 1 trial in 299 Type II diabetics showed that once-weekly subcutaneous 30 mg albiglutide plus Actos pioglitazone with or without metformin met the primary endpoint of reducing HbA1c from baseline to week 52 vs. placebo plus Actos with or without metformin (0.81% vs. 0.05%, p<0.0001). On secondary endpoints, albiglutide plus Actos significantly reduced FPG vs. placebo plus Actos (23.1 mg/dL vs. a gain of 6.4 mg/dL, p<0.0001), but led to a non-significant change in body weight (gain of 0.28 kg vs. a gain of 0.45 kg, p=0.7193). Additionally, 44% of patients in the albiglutide arm achieved an HbA1c of <7% vs. 15% for the placebo arm (p<0.0001). The most common adverse events were injection-site reactions and gastrointestinal complaints of primarily nausea and diarrhea. The trial enrolled Type II diabetics who were inadequately controlled on Actos with or without metformin. 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. ...