Garber 2006.

Methods	DURATION OF INTERVENTION: 24 weeks DURATION OF FOLLOW‐UP: 24 weeks RUN‐IN PERIOD: during the 1‐week, open‐label lead‐in phase, patients maintained their prescreening dosage of >= 1500 mg/day metformin therapy; LANGUAGE OF PUBLICATION: English
Participants	WHO PARTCIPATED: type 2 diabetes patients inadequately controlled on metformin monotherapy. INCLUSION CRITERIA: adults (age 20–78 years) with established type 2 diabetes requiring oral therapy; before screening, patients were required to be on a stable dosage of metformin >= 1500 mg/day for >= 8 weeks, HbA1c levels >7.0 and <= 12.0% and BMI >= 23 and <= 45; only patients willing and able to perform self‐blood glucose; women of childbearing potential had to practise acceptable methods of birth control and to have negative pregnancy test results within 72 h of study treatment EXCLUSION CRITERIA: marked polyuria and polydipsia with >10% weight loss; the use of any hypoglycaemic agent other than metformin within 8 weeks before screening; anaemia [haemoglobin level: <12.5 g/dl (men) and <11.0 g/dl (women)] and significantly abnormal renal, cardiac or hepatic dysfunction or disease; pregnant or nursing women and patients with known sensitivity to any study medications were excluded. DIAGNOSTIC CRITERIA: not stated CO‐MORBIDITIES: not stated CO‐MEDICATIONS: not stated
Interventions	NUMBER OF STUDY CENTRES: 76 COUNTRY/ LOCATION: USA SETTING: not stated INTERVENTION (DOSE/DAY): metformin 500 mg plus rosiglitazone 4 mg/day (initial daily dose 1000–2000 mg + 4 mg, depending on previous treatment) [mean final dose of metformin plus rosiglitazone was 1819 and 7.1 mg] CONTROL (DOSE/DAY): metformin‐glibenclamide 500/2.5 mg/day (initial daily dose 1000/5 mg) [mean final dose of metformin‐glibenclamide tablets was 1509/7.6 mg] TREATMENT BEFORE STUDY: patients were required to be on a stable dosage of metformin >= 1500 mg/day for >= 8 weeks TITRATION PERIOD: patients were randomly assigned to one of two double‐blind treatments, according to the dose of metformin during the lead‐in phase: patients receiving 1500 mg/day metformin before screening received metformin‐glibenclamide 1000/5 mg/day (in divided doses) or metformin 1500 mg plus rosiglitazone 4 mg daily (in divided doses); those previously receiving >1500 mg/day were randomly assigned to metformin‐glibenclamide 1000/5 mg (in divided doses) or metformin 2000 mg plus rosiglitazone 4 mg daily (in divided doses) study medications were titrated based on mean daily glucose levels to achieve a therapeutic glycaemic target
Outcomes	PRIMARY OUTCOMES: change in HbA1c from baseline to week 24 or the last prior blinded visit SECONDARY OUTCOMES: changes in body weight and changes in fructosamine, FPG, 2‐h postprandial plasma glucose and fasting insulin levels from baseline to week 24 or the last prior blinded visit; proportion of patients achieving therapeutic glycaemic response (HbA1c levels <7.0% and FPG levels <7 mmol/L) at week 24 or the last prior blinded visit; safety outcomes included adverse events, particularly hypoglycaemic symptoms; standard haematology, serum chemistry and urinalysis
Notes	AIM OF STUDY: to compare the effects of two combination regimens, metformin‐glibenclamide combination tablets versus metformin plus rosiglitazone in patients inadequately controlled on metformin monotherapy.
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear