Albiglutide meets Phase III endpoint

Human Genome Sciences Inc. (NASDAQ:HGSI) and partner GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) said once-weekly subcutaneous albiglutide was superior to Januvia sitagliptin on the primary endpoint of reducing HbA1c from baseline to week 26 in the Phase III Harmony 8 trial in 507 Type II diabetics with renal impairment (0.83% vs. 0.52%, p<0.0001 for non-inferiority and p=0.0003 for superiority). Albiglutide is a fusion protein of human albumin and glucagon-like peptide-1 (GLP-1).

The double-blind, international trial enrolled diabetics who were inadequately controlled on their regimen of diet and exercise or their anti-diabetic regimen of metformin, thiazolidinedione, sulfonylurea or any combination of the oral medications. Harmony 8 is the third of eight trials in the Harmony program. In Harmony 6, albiglutide plus Lantus insulin glargine met the primary endpoint of non-inferiority to preprandial insulin lispro plus Lantus. In Harmony 7, albiglutide missed the primary endpoint of non-inferiority to Victoza liraglutide. ...