LONDON, RESEARCH TRIANGLE PARK, N.C., and NEW ORLEANS, June 7 /PRNewswire-FirstCall/ -- New Phase II data presented today at the American Diabetes Association 69th Scientific Sessions in New Orleans show that the investigational type 2 diabetes treatment Syncria(R) (albiglutide) significantly reduced blood glucose levels and provided weight loss across weekly, biweekly and monthly dosing. Reducing blood sugar is a key part of managing type 2 diabetes, a disease that affects over 250 million people worldwide.
In the study, dose-dependent reductions in A1C - a measure of how well blood sugar is being controlled over time - with albiglutide 30 mg weekly, 50 mg biweekly, and 100 mg monthly were 0.9%, 0.8% and 0.9% respectively (p<0.05). The A1C reduction by placebo was 0.2% and by open-label exenatide was 0.5%. Weight loss (0.9 to 1.8 kg) was observed across all doses. The most frequently reported adverse events included nausea, vomiting and headache. At the 30 mg weekly dose, fewer than 10% of patients experienced nausea and vomiting, which subsided after week eight. Albiglutide was not shown to increase the risk of abnormally low blood sugar, known as hypoglycemia.
“Despite a range of available diabetes therapies, over half of patients with type 2 diabetes are unable to achieve the ADA target blood sugar goal,” said the study’s lead investigator, Julio Rosenstock, MD of the Dallas Diabetes and Endocrine Center at Medical City and clinical professor of medicine, University of Texas Southwestern Medical School. “While these results need to be confirmed in ongoing studies, the findings with albiglutide are important since weight gain and fear of increased blood sugar levels can be major barriers to diabetes management.”
Study design
The primary objective of the study was to evaluate the dose response of albiglutide for safety and efficacy. The primary efficacy endpoint was change from baseline A1C at week 16 versus placebo across different doses within each schedule (weekly, biweekly, and monthly). The trial was a randomized, multi-center, double-blind, parallel-group study in 356 subjects with type 2 diabetes previously treated with diet and exercise or metformin (mean baseline A1C 8%). Patients received subcutaneous placebo, albiglutide weekly, (4, 15 or 30 mg), biweekly (15, 30 or 50 mg) or monthly (50 or 100 mg), or exenatide (open-label reference arm, in metformin-treated patients) over 16 weeks.
About Albiglutide
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 meal to help the body utilise and control the elevation in blood sugar levels. However, GLP-1 is rapidly degraded, resulting in its short duration of action. In people with type 2 diabetes, GLP-1 secretion in response to a meal is reduced. Albiglutide is the only medication which fuses modified human GLP-1 to human albumin, a protein found in the blood plasma. It is designed to have an extended duration of action and allow for weekly or less-frequent injections. The Phase III programme for albiglutide began with five studies in early 2009 and is expected to last 2-3 years. The 30 mg weekly dose has been selected for the Phase III programme.
GlaxoSmithKline - one of the world’s leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com
Syncria(R) is the registered trademark to be used in the United States.
Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK’s operations are described under ‘Risk Factors’ in the ‘Business Review’ in the company’s Annual Report on Form 20-F for 2008.
Note: Dr. Rosenstock has received research grants and consulting honoraria for scientific advisory boards from GSK.
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