Phillips 2001.

Methods	DURATION OF INTERVENTION: 26 weeks DURATION OF FOLLOW‐UP: 26 weeks RUN‐IN PERIOD: 4‐week placebo LANGUAGE OF PUBLICATION: English
Participants	WHO PARTCIPATED: type 2 diabetes patients INCLUSION CRITERIA: age 40–80 years; BMI 22–38 kg/m2; type 2 diabetes as defined by the NDDG; FPG 7.8–16.7 mmol/L (140–300 mg/dl), and fasting C‐peptide >= 0.27 nmol/L (>= 0.8 ng/ml) at the time of screening EXCLUSION CRITERIA: clinically significant renal disease, NYHA class III‐IV, coronary insufficiency or congestive heart failure, symptomatic diabetic neuropathy, or elevations in total bilirubin, alkaline phosphatase, alanine aminotransferase (ALT), or aspartate aminotransferase 2.5 times the upper limit DIAGNOSTIC CRITERIA: NDDG 1979 CO‐MORBIDITIES: not stated CO‐MEDICATIONS: not stated
Interventions	NUMBER OF STUDY CENTRES: 65 COUNTRY/ LOCATION: USA SETTING: not stated INTERVENTION (DOSE/DAY): I1: rosiglitazone 4 mg/day (4mg o.d) I2: rosiglitazone 4 mg/day (2 mg b.i.d.) I3: rosiglitazone 8 mg/day (8 mg o.d.) I4: rosiglitazone 8 mg/day (4 mg b.i.d.) CONTROL (DOSE/DAY): placebo TREATMENT BEFORE STUDY: oral antihyperglycaemic agents were discontinued at least 14 days before a 4‐week placebo run‐in period diet only (%) ‐ I1: 22.1, I2: 24.7, I3: 29.3, I4: 25.1, C: 22.5 oral monotherapy (%) ‐ I1: 61.3, I2: 55.9, I3: 54.7, I4: 64.7, C: 61.8 oral combination therapy (%) ‐ I1: 16.6, I2: 19.4, I3: 16.0, I4: 10.2, C1: 15.6 TITRATION PERIOD: none
Outcomes	PRIMARY OUTCOMES: change in HbA1c from baseline (end of the 4‐week placebo run‐in period) after 26 weeks of treatment SECONDARY OUTCOMES: the change from baseline after 26 weeks of treatment in FPG, immunoreactive insulin, C‐peptide, lipid levels Clinical chemistry, hematology, liver enzymes, and urinalysis; HOMA
Notes	AIM OF STUDY: to examine the efficacy of rosiglitazone in reducing HbA1c and to evaluate the therapeutic equivalence of once‐daily and twice‐daily dosing regimens.
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear