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Intensive and standard glucose control did not differ for CV events or death in poorly controlled type 2 diabetes

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STUDY DESIGN

Design:

randomised controlled trial (Veterans Affairs Diabetes Trial [VADT]). ClinicalTrials.gov NCT00032487.

Allocation:

unclear allocation concealment.*

Blinding:

blinded (outcome assessors).*

STUDY QUESTION

Setting:

20 sites in the USA.

Patients:

1791 patients (mean age 60 y, 97% men) who had inadequate responses to maximum doses of an oral agent or insulin therapy. Exclusion criteria included glycated haemoglobin (HbA1c) concentration <7.5%, cardiovascular (CV) event in the past 6 months, advanced congestive heart failure (CHF), severe angina, body mass index (BMI) >40 kg/m2, serum creatinine concentration >1.6 mg/dl (141 µmol/l), and alanine aminotransferase concentration >3 times the upper normal limit.

Intervention:

intensive (n = 892) or standard glucose control (n = 899). Patients were given oral metformin plus rosiglitazone (BMI ⩾27 kg/m2) or oral glimepiride plus rosiglitazone (BMI <27 kg/m2). The intensive-control group …

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