GlaxoSmithKline (GSK) has achieved topline results from seven of the eight Harmony Phase III studies investigating the use of albiglutide in patients with type 2 diabetes.
Albiglutide is an investigational biological injectable human glucagon-like peptide-1 (GLP-1) agonist that acts throughout the body to help maintain normal blood-sugar levels and control appetite.
The Phase III clinical development programme of albiglutide included eight individual studies, known as Harmony 1 to Harmony 8, evaluating the efficacy, tolerability and safety, including cardiovascular safety of the drug as mono and add-on therapy, in patients with type 2 diabetes.
The primary efficacy endpoint for all studies was the change from baseline in HbA1c compared to placebo and/or active comparators, including sulphonylurea, thiazolidinedione (TZD), insulin and a dipeptidyl peptidase four inhibitor (DPP IV).
In Harmony 6, albiglutide produced considerable reductions in HbA1c from baseline and non-inferiority compared to preprandial lispro insulin after 26 weeks of treatment, achieving the primary endpoint.
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The study 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, while weight change from baseline was -0.73kg in the albiglutide arm and +0.81kg in the preprandial lispro insulin arm.
The head-to-head Harmony 7 study showed that patients receiving albiglutide demonstrated a reduction in HbA1c of 0.78% compared to a reduction of 0.99% for liraglutide, but it failed to meet the pre-specified primary endpoint of non-inferiority to liraglutide.
As well as the data from Harmony 6, 7 and 8 and the two-year data from the five ongoing studies, a meta-analysis of cardiovascular safety data will be required to complete the registration package as per the Food and Drug Administration guidelines.
The Harmony 8 study is scheduled for completion in mid 2012, and the remaining five studies are anticipated to be completed in early 2013.
Image: The current world headquarters of GlaxoSmithKline in Brentford, London. Photo: Maxwell Hamilton.