A Patel

Dr A Patel, University of Sydney, Sydney, New South Wales, Australia; apatel@george.org.au

STUDY DESIGN

Design:

randomised controlled trial (Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation [ADVANCE]).

Allocation concealment:

concealed.*

Blinding:

blinded (outcome adjudication committee).*

STUDY QUESTION

Setting:

215 centres in 20 countries in Asia, Australasia, Europe, and North America.

Patients:

11 140 patients ⩾55 years of age (mean age 66 y, 58% men) who had type 2 diabetes and a history of, or risk factors for, vascular disease. Patients requiring insulin were excluded.

Intervention:

intensive glucose control with gliclazide modified-release, 30–120 mg/d, and other non-sulfonylurea drugs as needed to achieve a target glycated haemoglobin concentration ⩽6.5% (n = 5571) or standard glucose control with drugs other than gliclazide (n = 5569).

Outcomes:

composite of macrovascular events (non-fatal myocardial infarction or stroke, or death from cardiovascular causes) and composite of microvascular events (new or worsening nephropathy [including macroalbuminuria] or retinopathy). Secondary outcomes included new-onset microalbuminuria and severe hypoglycaemia.

Follow-up period:

median 5 years. …