Lebovitz 2001.

Methods	DURATION OF INTERVENTION: 26 weeks DURATION OF FOLLOW‐UP: 26 weeks RUN‐IN PERIOD: 4‐week single blind placebo baseline period (instruction on a weight maintenance diet) LANGUAGE OF PUBLICATION: English
Participants	WHO PARTCIPATED: patients with type 2 diabetes whose hyperglycemia was inadequately controlled by diet or an oral antihyperglycemic agent INCLUSION CRITERIA: 36–81 years old, patients with a diagnosis of type 2 diabetes (as defined by the NDDG) if they had FPG between 7.8 –16.7 mmol/L, fasting plasma C‐peptide level greater than 0.26 nmol/L, and a body mass index (BMI) between 22–38 kg/m2 at screening EXCLUSION CRITERIA: patients with angina or cardiac insufficiency NYHA class III or IV; renal impairment (serum creatinine > 159 mmol/L), hepatic disease (alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, or total bilirubin, > 2.5 times the upper limit of the reference range); history of diabetic ketoacidosis, history of chronic insulin use, symptomatic diabetic neuropathy; a serious major illness that would compromise their participation; women of childbearing potential DIAGNOSTIC CRITERIA: NDDG 1979 CO‐MORBIDITIES: not stated CO‐MEDICATIONS: not stated
Interventions	NUMBER OF STUDY CENTRES: 42 COUNTRY/ LOCATION: USA SETTING: not stated INTERVENTION (DOSE/DAY): I1: rosiglitazone 4 mg/day (2 mg twice daily) I2: rosiglitazone 8 mg/day (4 mg twice daily) CONTROL (DOSE/DAY): placebo TREATMENT BEFORE STUDY: diet or an oral antihyperglycemic agent drug naive (%) ‐ I1: 26.5, I2: 26.6, C: 28.5 prior monotherapy (%) ‐ I1: 68.7, I2: 65.7, C1: 63.9 prior combination therapy (%) ‐ TITRATION PERIOD: screening period of up to 14 days (during which patients discontinued all antidiabetic medications); 4‐week run‐in; 26 weeks treatment period
Outcomes	PRIMARY OUTCOMES: change in HbA1c from baseline to 26 weeks SECONDARY OUTCOMES: (not stated) comparisons of rosiglitazone with placebo for changes from baseline to week 26 in FPG, C‐peptide, immunoreactive insulin, proinsulin, 32–33 split proinsulin, fructosamine, urinary albumin excretion as determined by urinary albumin/creatinine ratio (ACR), and serum lipids; the proportions of patients who had a reduction in HbA1c of more than 1 percentage point or a reduction in FPG of more than 1.67 mmol/L at week 26 compared with baseline; HOMA; interim medical histories, reports of adverse events, and standard laboratory assessments (including clinical chemistry, hematology, and urinalysis) were obtained at each visit; ECGs
Notes	AIM OF STUDY: to assess the efficacy and safety of rosiglitazone monotherapy in patients with type 2 diabetes whose hyperglycemia was inadequately controlled by diet or an oral antihyperglycemic agent
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear