Syncria (GSK) superior to Januvia in HARMONY 8 study in Renally Impaired Diabetes patients - 13-Jul-2012

The Harmony 8 study is a 52-week randomised, double-blind, active-controlled, parallel-group, multicenter study, which is comparing Syncria (albiglutide) from GSK to Januvia (sitagliptin), a DPP-4 inhibitor marketed by Merck & Co, in 507 Type 2 Diabetes patients with mild, moderate and severe renal impairment.

Patients were randomised to receive albiglutide (30mg weekly with up-titration to 50mg weekly based on glycemic response) plus sitagliptin matching placebo, or sitagliptin (as per label: 25 to 100mg depending on degree of renal insufficiency) plus albiglutide matching placebo. Patients were treated for 52 weeks and the primary endpoint was a comparison between albiglutide and sitagliptin in the reduction of HbA1c from baseline at Week 26; secondary endpoints included other parameters of glucose control, weight, and safety and tolerability.

GSK has reported that at 26-weeks, albiglutide met its primary endpoint and showed clinically significant reductions in glycated hemoglobin (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 week 26, weight loss was significantly greater in the albiglutide group than the sitagliptin group (-0.79kg vs -0.19kg; p=0.0281).