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ARTICLE | Clinical News

Albiglutide: Phase III data

July 1, 2013 7:00 AM UTC

The open-label, international Phase III Harmony 4 trial in 735 Type II diabetics who were inadequately controlled on metformin with or without a sulfonylurea showed that once-weekly subcutaneous 30 mg albiglutide met the primary endpoint of non-inferiority to Lantus insulin glargine in reducing HbA1c from baseline to week 52 (0.67% vs. 0.79%, 95% CI: 0.04%, 0.27%; p=0.0086 for non-inferiority, p=0.1463 for superiority). The pre-specified threshold to meet the endpoint was indicated by an upper limit of the 95% CI of 0.3%. On secondary endpoints, albiglutide led to a significant improvement in body weight vs. Lantus (loss of 1.05 kg vs. a gain of 1.56 kg, p<0.0001), while Lantus significantly reduced FPG vs. albiglutide (37.1 vs. 15.7 mg/dL, p<0.0001). 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. ...