ADVANCE (Action in Diabetes and Vascular Disease), the largest clinical trial ever performed in patients with type 2 diabetes worldwide, is now complete.
The second and final part of this five-year trial investigates the effect of intensive blood glucose lowering treatment on major macrovascular (cardiovascular death, MI, stroke) and microvascular (kidney and eye disease) events.
Over 11,000 patients were randomised and more than 20 countries participated in ADVANCE. The final patient visits were made at the end of January 2008, and the database is now closed and main analysis complete.
The data from the blood glucose lowering arm of ADVANCE will be presented for the first time at the American Diabetes Association Scientific Sessions on 6 June 2008 in San Francisco, USA.
“People with diabetes have a two to four-fold greater risk of experiencing a cardiovascular event compared to non-diabetics. However, despite this high risk, there is surprisingly little evidence about the role of intensive blood glucose control in the prevention of diabetic vascular disease”, points out the ADVANCE Principal Investigator Professor John Chalmers from The George Institute for International Health, Sydney.
ADVANCE Study Director, Associate Professor Anushka Patel, added: “ADVANCE will provide new and robust evidence on whether intensive glucose lowering treatment improves outcomes and could have huge implications for the practical management of type 2 diabetes worldwide.”
ADVANCE was designed to answer two questions: first, does intensive treatment to lower blood pressure improve outcome; and second, does intensive treatment to reduce blood glucose improve outcome?
The first question was answered by the results of the blood pressure lowering arm of the study in which a treatment regimen including the fixed combination of the ACE inhibitor perindopril and the diuretic indapamide was shown to reduce mortality in patients with diabetes.
The results of glucose-lowering arm, (based on gliclazide modified release, MR and a range of other drugs) of the ADVANCE study will provide the answer to the second question when announced later this year.
ADVANCE was conducted in 215 clinical centres selected from Australasia, Asia, Europe and North America.