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news.GlaxoSmithKline (GSK) has unveiled data from five Phase III studies (Harmony 1 to 5) comparing albiglutide placebo and a range of active comparators, including insulin, a sulphonylurea (SU), a thiazolidinedione (TZD), and a dipeptidyl peptidase four inhibitor (DPP-4).
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Albiglutide is an investigational glucagon-like peptide receptor agonist (GLP-1), which is an investigational once a week treatment for type 2 diabetes.
Comprising eight individual studies (Harmony 1 to Harmony 8) and involving more than 5,000 patients, the Harmony Phase III program investigated the efficacy, tolerability and safety, including cardiovascular safety, of albiglutide as mono- and add-on therapy, in patients with type 2 diabetes.
The primary endpoint for the Phase III studies was the change from baseline in HbA1c compared to placebo and/or active comparators assessed after one or two years of treatment, while the secondary endpoints included fasting plasma glucose (FPG) and weight.
Albiglutide achieved the primary efficacy endpoint in five studies, although a hierarchical analysis of noninferiority to pioglitazone was not met in one of the five studies.
Harmony 1, 2, 4 and 5 are 3-year, 52-week primary endpoint, randomised, double-blind, placebo-controlled studies, whereas Harmony 3 was a 3-year, 104-week primary endpoint, randomised, double-blind, placebo- and active-controlled, parallel-group study.
The most commonly reported adverse reactions in the studies were said to be gastrointestinal (GI) complaints, primarily nausea and diarrhea, and injection site reactions.