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news.GlaxoSmithKline has initiated dosing of the first patient in the Phase III clinical trial program to evaluate the efficacy, safety and tolerability of the investigational GLP-1 agonist Syncria in men and women with type 2 diabetes.
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The Phase III program will include more than 4,000 patients. The Phase III program for albiglutide will begin with five studies in early 2009. The objective of the program 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 or active comparators. A majority of the studies will include active comparators, including metformin, sulphonylurea, thiazolidinedione insulin and a dipeptidyl peptidase four inhibitor.
The study duration is expected to be two to three years and the main dose and regimen for the program will be 30mg weekly.
Carlo Russo, senior vice president of biopharm development at GlaxoSmithKline, said: 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. 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.