Albiglutide: Phase III data

The double-blind Phase III Harmony 5 trial in 657 Type II diabetics on a background of metformin and glimepiride showed that once-weekly subcutaneous 30 mg albiglutide met the primary endpoint of reducing HbA1c from baseline to week 52 vs. placebo (0.55% vs. a gain of 0.33%, p<0.0001). Per the trial's protocol, a stepwise statistical analysis was first conducted comparing albiglutide to placebo followed by non-inferiority testing vs. Actos pioglitazone. Albiglutide missed the endpoint of non-inferiority to Actos in reducing HbA1c from baseline to week 52 (0.8% reduction for Actos, 95% CI: 0.1%, 0.4%; p=0.27 for non-inferiority). 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 significantly reduced FPG by 12.4 mg/dL vs. a gain of 11.5 mg/dL for placebo (p<0.0001). Actos reduced FPG by 31.4 mg/dL. Additionally, albiglutide and placebo each led to reductions in body weight of 0.4 kg compared to a gain of 4.4 kg for Actos (p<0.0001 for albiglutide vs. Actos). 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. ...