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Intensive glucose control did not prevent important complications in type 2 diabetes

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A Patel

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

QUESTION

In type 2 diabetes, does intensive glucose control prevent adverse outcomes more than standard glucose control?

METHODS

Design:

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

Allocation:

concealed.

Blinding:

blinded (outcome adjudication committee).

Follow-up period:

median 5 years.

Setting:

215 centres in 20 countries worldwide.

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/day, and other non-sulfonylurea drugs as needed to achieve a target glycated haemoglobin (HbA1c) concentration ⩽6.5% (n = 5571) or standard glucose control with drugs other than gliclazide (n = 5569).

Outcomes:

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

Patient follow-up:

95% (intention-to-treat analysis). …

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