Diabetes Mellitus, Type 2 Clinical Trial
Official title:
ADVANCE - Action in Diabetes and Vascular Disease: Preterax and Diamicron - MR Controlled Evaluation
The purpose of this study is to provide information on the risks and benefits of routine blood pressure lowering (regardless of blood pressure level), and intensive lowering of blood glucose levels, in patients with Type 2 diabetes at high risk of cardiovascular events. The major outcomes of the study will be cardiovascular events (heart attack, stroke or dying as a result of cardiovascular disease), as well as new or worsening diabetic eye and kidney disease.
Patients with type 2 diabetes are at increased risks of macrovascular and microvascular
disease, both of which are reduced by control of raised blood pressure in hypertensive
individuals. Intensive glycaemic control has also been shown to reduce microvascular
disease, but the effects on macrovascular disease remain uncertain. This study will examine
the hypotheses that blood pressure lowering (with an ACE inhibitor-diuretic combination) and
intensive glycaemic control (with a sulphonylurea-based regimen) in high-risk individuals
with type 2 diabetes (including hypertensive and non-hypertensive subjects) reduces the
incidence of both macrovascular and microvascular disease.
The study is a 2 x 2 factorial randomised controlled trial that includes 11,140 adults with
type 2 diabetes at elevated risk of vascular disease. Following 6 weeks on open label
perindopril-indapamide combination, eligible individuals were randomised to continued
perindopril-indapamide or matching placebo, and to an intensive gliclazide MR-based glucose
control regimen (aiming for HbA1c of 6.5% or lower) or usual guidelines-based therapy.
Primary outcomes are, first, the composite of non-fatal stroke, non-fatal myocardial
infarction or cardiovascular death and, second, the composite of new or worsening
nephropathy or diabetic eye disease. These primary outcomes will be analysed jointly and
separately. The average duration of treatment and follow-up is 5.5 to 6 years. The study is
being conducted in 214 centres in Australasia, Asia, Europe and North America.
ADVANCE is designed to provide reliable evidence about the balance of benefits and risks
conferred by blood pressure lowering therapy and intensive glucose control therapy in
high-risk diabetic patients, irrespective of initial blood pressure or glucose levels.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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