GlaxoSmithKline announced that topline results have been received from seven of the eight Harmony Phase 3 studies investigating the use of albiglutide in type 2 diabetes.
The Phase 3 clinical development program for albiglutide comprises eight individual studies, known as Harmony 1 to Harmony 8. 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. The primary efficacy endpoint for all studies is the change from baseline in HbA1c compared to placebo and/or active comparators. A majority of the studies will include active comparators, including sulfonylurea, thiazolidinedione (TZD), insulin and a dipeptidyl peptidase four inhibitor (DPP IV).
In Harmony 6, the second of the phase 3 Harmony studies to complete, albiglutide was compared to preprandial insulin, each administered on top of long-acting insulin glargine (Lantus; Sanofi Aventis). In this study, albiglutide produced clinically significant reductions in HbA1c from baseline and non-inferiority versus preprandial lispro insulin (Humalog; Eli Lilly and Company) 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).
Initial data from the first study to complete, Harmony 7, a head-to-head study comparing albiglutide to once-a-day liraglutide, were announced in November 2011.
GSK also announced that 2 year data read-outs from five ongoing phase 3 studies (Harmony 1 through Harmony 5) have been received. These read-outs present the final results for primary endpoint data up to two years. As the five ongoing studies have not completed, these data remain confidential.
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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