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ARTICLE | Clinical News

GSK reports remaining HARMONY data for albiglutide

June 25, 2013 12:45 AM UTC

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) presented data at the American Diabetes Association meeting from the remaining five trials in the eight-trial Phase III Harmony program evaluating Eperzan albiglutide in over 5,000 Type II diabetics. A BLA for the product --a once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist comprised of two copies of modified human GLP-1 fused in series to human albumin -- is under FDA review and an MAA is under EMA review to treat Type II diabetes.

In Harmony 1, albiglutide plus Actos pioglitazone from Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) 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). The trial enrolled 299 diabetics inadequately controlled on Actos with or without metformin. In Harmony 2, albiglutide each met the primary endpoint of reducing HbA1c from baseline to week 52 vs. placebo (placebo-adjusted reductions of 0.84% for low-dose albiglutide and 1.04% for high-dose albiglutide, p<0.0001 for both). The trial enrolled 296 previously untreated diabetics. ...