U.K.-based drug maker GlaxoSmithKline plc (GSK, GSK.L) announced data from five Phase III studies of albiglutide, an investigational once-weekly treatment for type 2 diabetes.
The company presented the data at the American Diabetes Association Meeting in Chicago from five long-term Phase III studies comparing albiglutide, an investigational glucagon-like peptide receptor agonist (GLP-1), to placebo and a range of active comparators.
The company said that the primary efficacy endpoint for these studies was the change from baseline in HbA1c compared to placebo and/or active comparators assessed after one or two years of treatment. Secondary endpoints included fasting plasma glucose or FPG and weight. These studies were specifically designed to assess durability of albiglutide effect on HbA1c and other continuous variables when used in various combination therapies, at different stages of the disease, and in various degrees of renal impairment.
According to the company Albiglutide achieved the primary efficacy endpoint in these five studies, although a hierarchical analysis of noninferiority to pioglitazone was not met in one study. The most commonly reported adverse reactions in these studies were gastrointestinal (GI) complaints, primarily nausea and diarrhoea, and injection site reactions.
Albiglutide, a GLP-1 receptor agonist, is an investigational biological product for the treatment of type 2 diabetes designed for once-weekly subcutaneous dosing. GLP-1 is a peptide that is normally secreted from the gastrointestinal tract during a meal which in turn helps release insulin to control blood sugar elevations after eating. In people with type 2 diabetes, GLP-1 secretion in response to a meal is reduced or absent. Albiglutide is currently undergoing regulatory review for the treatment of type two diabetes in the US and European Union.
by RTT Staff Writer
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