ADVANCE: largest clinical trial in diabetes care
With diabetes at epidemic proportions around the world, Australian research group, the Institute for International Health will coordinate one of the world's largest international trials on management of diabetic patients.
The study, Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation (ADVANCE), aims to address two important questions related to the care and well being of people with Type 2 diabetes.
The first question will focus on the role of intensive blood pressure lowering in diabetic patients and the second on the role of intensive glucose control. More intensive management of blood pressure and glucose levels in diabetic patients (whether they are hypertensive or normotensive) is expected to reduce the risk of major complications such as heart attack, stroke, blindness and kidney failure.
The study is a randomised, controlled trial and has just begun to recruit the required 10,000 participants from about 200 clinical centres in 20 countries in Asia, Australasia, Europe and North America.
Participants in the trial will receive, a fixed low-dose antihypertensive agent, perindopril-indapamide combination, or matching placebo as well as an intensive, modified-release gliclazide-based glucose lowering regimen or standard guidelines-based glucose lowering therapy.
Diabetes is the world's fastest growing disease and Australia's seventh leading cause of death. Typically diagnosed in patients over 50 years there is now a trend for younger people to be identified with diabetes. With no cure on the horizon, management of the complications of diabetes is focus of many public health researchers.
The ADVANCE trial is based on earlier observational studies that have shown high blood pressure and poorly controlled glucose levels in diabetic patients results in increased risk of stroke, heart attack, vision problems and kidney disease.
The ADVANCE study design also incorporates evidence from a prior smaller trial suggesting that lowering blood pressure and glucose to levels below those recommended in standard guidelines in diabetic patients will further reduce the risk of major vascular complications.
ADVANCE will test this theory and determine whether intensive lowering of blood pressure and glucose levels does indeed lead to further significant reductions in major events among diabetic patients regardless of whether they have high blood pressure or not.
Patients in the study will be followed up for an average of 4.5 years with final results of the study expected in 2006.