Derosa 2006b.

Methods	DURATION OF INTERVENTION: 12 months DURATION OF FOLLOW‐UP: 12 months RUN‐IN PERIOD: none LANGUAGE OF PUBLICATION: English
Participants	WHO PARTCIPATED: type 2 diabetic patients with inadequate control on diet and oral hypoglycaemic agents INCLUSION CRITERIA: patients with metabolic syndrome diagnosis according to National Cholesterol Education Program (NCEP) (ATP III) classification and they presented at least three following components: 1. type 2 diabetes mellitus. 2. triglyceridemia >= 150 mg/dl. 3. Blood pressure >= 130/85 mmHg type 2 diabetes mellitus, according to ADA criteria; all were required to have been diagnosed as being diabetic for at least 6 months and did not have adequate glycaemic control (as suggested by ADA guidelines) with diet and oral hypoglycaemic agents such as sulphonylureas or metformin, both to the maximum tolerated dose; no patients were taking glimepiride or thiazolidinediones; all patients had a fasting C‐peptide level > 1.0 ng/ml; mean BMI of 25.3; furthermore, patients were hypertensive according to the WHO 1999 criteria (systolic BP >= 130 mmHg and diastolic BP >= 85mm Hg) and had triglyceridaemia >= 150 mg/dl EXCLUSION CRITERIA: history of ketoacidosis; unstable or rapidly progressive diabetic background retinopathy, nephropathy (microalbuminuria, evaluated by proteinuria <300mg/24 h) or neuropathy (evaluated by electromyography); impaired liver function (transaminases > 40 U/L), impaired kidney function (creatinine > 1.5mg/dl) or anaemia (Hb < 11.5 g/L); unstable cardiovascular conditions (e.g. NYHA class III or IV congestive heart failure or a history of myocardial infarction or stoke) or cerebrovascular conditions within 6months of study enrolment; women who were pregnant, lactating, or of child‐bearing potential while not taking adequate contraceptive precautions DIAGNOSTIC CRITERIA: ADA 2001 CO‐MORBIDITIES: not stated CO‐MEDICATIONS: at entry, 42 patients (44.2%) were taking antihypertensive drugs [16 participants, ACE‐inhibitors (38.1%); 12 participant, calcium antagonists (28.6%); 10 participants, AT II antagonists (23.8%) and four patients, alpha1‐antagonists (9.5%)]; no patients were taking lipid‐lowering or antiaggregation drugs
Interventions	NUMBER OF STUDY CENTRES: 2 COUNTRY/ LOCATION: Italy SETTING: Department of Internal Medicine and Therapeutics at University of Pavia, the G. Descovich Atherosclerosis Study Center, D. Campanacci Clinical Medicine and Applied Biotechnology Department at University of Bologna INTERVENTION (DOSE/DAY): rosiglitazone 4 mg/day + metformin 1500 mg/day CONTROL (DOSE/DAY): glimepiride 2 mg/day+ metformin 1500 mg/day TREATMENT BEFORE STUDY: patients did not have adequate glycaemic control with diet and oral hypoglycaemic agents such as sulphonylureas or metformin, both to the maximum tolerated dose TITRATION PERIOD: none
Outcomes	PRIMARY OUTCOMES: changes in BMI, HbA1c, lipid profile and lipoprotein parameters were the primary efficacy variables SECONDARY OUTCOMES: (not stated) height, weight, BMI, HbA1c, FPG, PPG, fasting plasma insulin; postprandial plasma insulin; lipid profile and lipoprotein parameters; HOMA; adverse events
Notes	AIM OF STUDY: the aim of this study is to compare the metabolic changes induced by metformin associated to glimepiride or rosiglitazone in type 2 diabetic patients
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Low risk	A ‐ Adequate