logo
Share SHARE
FONT-SIZE Plus   Neg

GSK Announces Data From Five Phase III Studies Of Albiglutide - Quick Facts

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

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Social media app Snapchat has introduced a new location service, Snap Map, that will allow users of the app to see the location of all their friends on a map. The new feature will essentially allow a user to see where his friends are hanging out and what they are up to and also share his own location with friends in real time. The U.S. has suspended all imports of fresh beef from Brazil due to recurring concerns about the safety of the products. The suspension of shipments from Brazil, the fifth largest exporter of beef to the U.S., will remain in place until the Brazilian Ministry of Agriculture takes corrective action, the U.S. Department of Agriculture or USDA said in a statement. The annual Federal stress test was cleared by 34 top banks. The result shows strong capital levels and the ability of large banks to remain capitalized even in stressed situations. The Federal Reserve noted that these banks will be able to lend to households and businesses even at severe recession and throughout the economic cycle.
comments powered by Disqus
Follow RTT