New Hope for Type II Diabetics
GlaxoSmithKline in February 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® (albiglutide) in men and women with type 2 diabetes.
The Phase III program will include more than 4,000 patients and 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. 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.
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. In people with type 2 diabetes, GLP-1 secretion in response to a meal is reduced.
Albiglutide is the only medication that fuses human GLP-1 to human albumin. It is designed to have an extended duration of action and allow for weekly or less-frequent injections.
Source: PRNewswire 2/17/09
