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randomised controlled trial (Veterans Affairs Diabetes Trial [VADT]). ClinicalTrials.gov NCT00032487.
unclear allocation concealment.*
blinded (outcome assessors).*
20 sites in the USA.
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.
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 …
Source of funding: Veterans Affairs Cooperative Studies Program; American Diabetes Association; National Eye Institute.