Biotech Values

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GSK/HGSI's albiglutide, an investigational once weekly glucagon-like peptide-1 (GLP-1) agonist did not meet the pre-specified primary endpoint of non-inferiority to once daily liraglutide (95% CI: 0.08 - 0.34%).

Head-to-head study primary end point did not meet non-inferiority, but results support progression towards registration

GlaxoSmithKline (GSK) today announced that topline results have been received from the first of eight Phase III studies of albiglutide to complete in type 2 diabetes.

The study, known as Harmony 7, is a head-to-head study designed to compare albiglutide, an investigational once weekly glucagon-like peptide-1 (GLP-1) agonist, to once-a-day liraglutide, an approved treatment for type 2 diabetes, in the same class. The primary endpoint of the study was reduction in HbA1c, a marker of the amount of glucose in the blood.

Results showed a reduction in HbA1c of 0.78% for patients receiving albiglutide compared to a reduction of 0.99% for liraglutide. While albiglutide did demonstrate a statistically significant reduction in HbA1c from baseline (p<0.001), it did not meet the pre-specified primary endpoint of non-inferiority to liraglutide (95% CI: 0.08 - 0.34%).

http://www.fiercebiotech.com/press-releases/gsk-receives-initial-data-first-completed-phase-lll-study-albiglutide-type-