GlaxoSmithKline announced that data have been received from the Phase 3 Harmony 8 study and from the event driven meta-analysis for assessment of cardiovascular safety conducted across the albiglutide clinical program investigating its use in the treatment of type 2 diabetes.
The Phase 3 clinical development program for albiglutide comprises eight individual studies, known as Harmony 1 to Harmony 8, and involves approximately 5,000 patients. The program is investigating the efficacy, tolerability and safety, including cardiovascular safety, of albiglutide as mono- and add-on therapy, in patients with type 2 diabetes. A majority of the studies include active comparators, including a sulfonylurea, a thiazolidinedione (TZD), insulin and a dipeptidyl peptidase four inhibitor (DPP-4).
The Harmony 8 study was a 52-week randomized, double-blind, active-controlled, parallel-group, multicenter study, comparing albiglutide to sitagliptin (Januvia; Merck & Co., Inc.) in type 2 diabetes patients with renal impairment (n=507). Patients were randomized to receive albiglutide (30mg weekly with up-titration to 50mg weekly based on glycemic response) plus sitagliptin matching placebo, or sitagliptin (as per label: 25mg–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.
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 vs. 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).
For the albiglutide meta-analysis, an independent clinical endpoints committee adjudicated cardiovascular events across all eight Phase 3 Harmony studies and from one Phase 2 study. This analysis has now been completed and rules out excess cardiovascular risk according to a threshold pre-specified by the FDA.
Albiglutide is an investigational biological, once-weekly subcutaneous injectable form of human GLP-1. GLP-1 is a peptide that acts throughout the body to help maintain normal blood-sugar levels and to control appetite. Albiglutide fuses human GLP-1 to human albumin. It is designed to have the potential to extended duration of action and allow for weekly or less-frequent injections.
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