GSK announces progress in HARMONY Syncria programme for Type 2 Diabetes

Topline results have been received from seven of the eight �HARMONY� Phase III studies investigating the use of Syncria (albiglutide) from GSK in Type 2 Diabetes. Albiglutide is an investigational once weekly glucagon-like peptide-1 (GLP-1) agonist. In HARMONY 6, the second of the phase III �HARMONY� studies to complete, albiglutide was compared to preprandial insulin, each administered on top of long-acting insulin glargine. In this study, the first of its kind for the class, albiglutide produced clinically significant reductions in HbA1c from baseline and non-inferiority versus preprandial lispro insulin after 26 weeks of treatment, achieving the primary endpoint. Results showed a reduction in HbA1c from baseline of 0.82% for patients receiving albiglutide compared to a reduction of 0.66% for preprandial lispro insulin (p<0.0001 for non-inferiority. weight change from baseline was -0.73kg in the albiglutide arm and 0.81kg in the preprandial lispro insulin arm p><0.0001 for treatment difference. the most common adverse events observed more frequently in the albiglutide arm than the comparator arm in this 52 week study were gastrointestinal in nature nausea 13 for albiglutide versus 2.1 for preprandial lispro insulin and vomiting 7 for albiglutide versus 1.4 for preprandial lispro insulin.gsk anticipates data from both harmony 6 and harmony 7 will be presented at a scientific meeting in 2012. results from the other six studies will be submitted for presentation and publication once the studies complete.>