LONDON (dpa-AFX) - GlaxoSmithKline Plc. (GSK, GSK.L) 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. These data are the final elements required to complete the clinical registration package.
GSK said it 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 company noted that 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<0.0001 for non-inferiority and p=0.0003 for superiority).
At the primary endpoint, weight loss was significantly greater in the albiglutide group than the sitagliptin group (-0.79kg vs -0.19kg; p=0.0281).
A meta-analysis which demonstrates that a therapy will not result in an unacceptable increase in cardiovascular risk is required by the FDA for the registration and approval of any product for the treatment of type 2 diabetes in the US.
In addition to data from Harmony 8 and the CV meta-analysis, the clinical registration package will also include data from two other completed Phase III studies Harmony 6 and 7 and primary endpoint data from five remaining Phase III studies, Harmony 1 to 5.
The company said the data are currently in-house and support progression to registration; however as the five studies will not be completed until early 2013, the data have to remain confidential to protect the integrity of the ongoing blinded studies and in line with our agreement with regulatory authorities.
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