Sutton 2002.

Methods	DURATION OF INTERVENTION: 52 weeks DURATION OF FOLLOW‐UP: 52 weeks RUN‐IN PERIOD: 4‐week placebo run‐in period (single‐blind, with diet maintenance) LANGUAGE OF PUBLICATION: English
Participants	WHO PARTCIPATED: type 2 diabetic patients INCLUSION CRITERIA: patients aged 40–80 years were eligible if they met the NDDG definition forvtype 2 diabetes, with endogenous insulin production (fasting C‐peptide concentration >= 0.8 ng/ml at screening); female patients had to be postmenopausal, surgically sterile, or currently using hormonal contraceptives or intrauterine devices EXCLUSION CRITERIA: clinically significant renal disease (serum creatinine level >= 1.8 mg/dl) or hepatic disease (alanine transaminase, aspartate transaminase, total bilirubin, or alkaline phosphatase levels > 2.5 times the upper limit of the normal laboratory range); previous treatment for myocardial infarction; NYHA class III‐IV, coronary insufficiency or congestive heart failure; previous or existing treatment with ACE inhibitors, angiotensin II receptor antagonists, beta‐blockers, or calcium‐channel blockers; echocardiographic evidence of marked left ventricular hypertrophy at baseline; or uncontrolled BP (>160/>100 mmHg); whereas patients taking diuretics and lipid‐lowering agents were not excluded from the study, doses were not to be changed during the study unless deemed medically appropriate DIAGNOSTIC CRITERIA: NDDG CO‐MORBIDITIES: concomitant hypertension (%) ‐ I: 7.7, C: 7.0 CO‐MEDICATIONS: not stated
Interventions	NUMBER OF STUDY CENTRES: 19 COUNTRY/ LOCATION: USA SETTING: not stated INTERVENTION (DOSE/DAY): rosiglitazone 8 mg (4 mg b.i.d.) CONTROL (DOSE/DAY): glyburide TREATMENT BEFORE STUDY: previous antidiabetic treatment : diet only (%) ‐ I: 21.2, C: 18.2 single agent (%) ‐ I: 70.2, C: 69.7 combination therapy (%): I: 8.7, C: 12.1 2‐week screening period; previous oral antidiabetic medications were discontinued at the screening visit, at which time all patients received placebo and dietary instruction; patients were reevaluated at 2‐week intervals during the placebo run‐in period; those with FPG >= 140 mg/dl but <= 300 mg/dl at visits 2 and 3 were eligible to enter the treatment period TITRATION PERIOD: glyburide (q.i.d. or b.i.d.) was titrated at the discretion of the investigator to optimal glycemic effect over the first 8 weeks and then held constant for the duration of the study period; the dose of glyburide did not exceed 20 mg/day
Outcomes	PRIMARY OUTCOMES: change from baseline in left ventricular mass index, at weeks 28 and 52, with the between‐groups difference as the primary comparison of interest SECONDARY OUTCOMES: (not stated) changes from baseline to weeks 28 and 52 in left ventricular end‐diastolic volume and ejection fraction as well as mean values of BP, heart rate, arterial pressure, and pulse pressure (from 24‐h ambulatory monitoring); glycemic control (HbA1c and FPG); serum lipids fasting clinical laboratory tests, including chemistry, haematology, and urinalysis clinical interpretation of safety was based on review of ECG and echocardiographic data, adverse event reports, and laboratory values
Notes	AIM OF STUDY: to assess the effect of long‐term rosiglitazone treatment on cardiac structure/function and glycaemic control in patients with type 2 diabetes compared with glyburide
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear