GlaxoSmithKline has received data from the Phase III Harmony 8 study and meta-analysis for assessment of cardiovascular safety conducted across the albiglutide clinical programme.
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GSK plans to use the data for global regulatory submissions for its investigational glucagon-like peptide-1 (GLP-1) receptor agonist albiglutide to treat type 2 diabetes in early 2013.
The Harmony 8 study is a 52-week double-blind, randomised, active-controlled, parallel-group, multicenter study, comparing albiglutide to a DPP-4 inhibitor, sitagliptin, in type 2 diabetes patients with renal impairment (n=507) and is the first completed study of a GLP-1.
At the 26-week primary endpoint, albiglutide showed 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).
During the full 52-week treatment period, albiglutide was generally well tolerated with diarrhoea being the most common adverse event for albiglutide (10%) vs sitagliptin (6.5%).
Nausea and vomiting rates were relatively comparable across the albiglutide and sitagliptin treatment arms (4.8% vs. 3.3% for nausea; 1.6% vs. 1.2% for vomiting respectively).
In addition to data available 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.