GSK announces positive data from Harmony 8 and completion of clinical registration package for albiglutide in type 2 diabetes

Top Quote GlaxoSmithKline (GSK) today announced that data have been received from the Phase III Harmony 8 study and from the event driven meta-analysis for assessment of cardiovascular safety conducted across the albiglutide clinical programme. End Quote
  • (1888PressRelease) July 12, 2012 - These data are the final elements required to complete the clinical registration package. With these data now available and anticipating completion of the chemistry and manufacturing package in the next few months, GSK intends to commence global regulatory submissions for its investigational glucagon-like peptide-1 (GLP-1) receptor agonist albiglutide for the treatment of type 2 diabetes in early 2013. Albiglutide is not yet approved as a treatment for type 2 diabetes or any other indication anywhere in the world.

    The Harmony 8 study is a 52-week randomised, double-blind, active-controlled, parallel-group, multicenter study, comparing albiglutide to a DPP-4 inhibitor, sitagliptin, in type 2 diabetes patients with renal impairment (n=507). It is the first completed study of a GLP-1 agonist to assess efficacy and safety across the spectrum of renal impairment from mild to severe, and the third of eight Harmony Phase III studies to complete. At the 26-week primary endpoint, albiglutide showed clinically and statistically significant reductions in HbA1c from baseline (8.08% for albiglutide and 8.22% for sitagliptin)and superiority versus sitagliptin (reduction of 0.83% vs 0.52%; p

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