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GSK Initiates Phase III Programme for Novel Type 2 Diabetes Medication, Syncria(R) (albiglutide)
Date:2/17/2009

LONDON, Feb. 17 /PRNewswire-FirstCall/ -- GlaxoSmithKline today announced initiation and dosing of the first patient of the Phase III clinical trial programme to evaluate the efficacy, safety and tolerability of the investigational GLP-1 (Glucagon-like peptide 1) agonist Syncria(R) (albiglutide) in men and women with type 2 diabetes. The Phase III programme will include more than 4,000 patients.

"Despite continued advances in diabetes treatment, this devastating disease continues to increase at an alarming pace worldwide. It is clear that new therapies are needed to better control type 2 diabetes and to improve people's lives," said Carlo Russo, MD., Senior Vice President, Biopharm Development, GlaxoSmithKline. "Albiglutide is a novel biological currently being investigated to determine its potential to help people control their blood sugar, particularly when oral treatments alone may not provide an adequate response."

About the Phase III Programme

The Phase III programme for albiglutide will begin with five studies in early 2009. The objective of the programme is to demonstrate durable efficacy and cardiovascular safety of albiglutide as mono- and add-on therapy, in patients with type 2 diabetes. The primary efficacy endpoint for all studies will be the change from baseline in HbA1c compared to placebo and/or active comparators. A majority of the studies will include active comparators, including metformin, sulphonylurea, thiazolidinedione (TZD) insulin and a dipeptidyl peptidase four inhibitor (DPP IV). The study duration is expected to be two to three years and the main dose and regimen for the programme will be 30 mg weekly.

About Albiglutide and Type 2 Diabetes

Albiglutide is an investigational biological, injectable form of human GLP-1 -- a peptide that acts throughout the body to help maintain normal blood-sugar levels and to control appetite. Normally, GLP-1 levels rise during a
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SOURCE GlaxoSmithKline
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