Albiglutide: Phase III data

The double-blind, international Phase III Harmony 2 trial in 296 previously untreated Type II diabetics showed that once-weekly subcutaneous 30 and 50 mg doses of albiglutide each met the primary endpoint of reducing HbA1c from baseline to week 52 vs. placebo. Specifically, placebo-adjusted reductions in HbA1c were 0.84% for low-dose albiglutide and 1.04% for high-dose albiglutide (p<0.0001 for both). On secondary endpoints, low-dose albiglutide reduced FPG by 34 mg/dL and high-dose albiglutide reduced FPG by 43 mg/dL vs. 18 mg/dL for placebo (p<0.0001 for both). Body weight was reduced by 0.4 kg for low-dose albiglutide and 0.9 kg for high-dose albiglutide vs. 0.7 kg for placebo. The most common adverse events were injection-site reactions and gastrointestinal complaints of primarily nausea and diarrhea. The trial enrolled Type II diabetics with an HbA1c of 7-10% on diet and exercise. 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. ...