Yang 2002.
Methods | DURATION OF INTERVENTION: 6 months DURATION OF FOLLOW‐UP: 6 months RUN‐IN PERIOD: single‐blind placebo/sulfonylurea run‐in period for 4 weeks to establish baseline characteristics LANGUAGE OF PUBLICATION: English | |
Participants | WHO PARTCIPATED: type 2 diabetic patients on concurrent sulphonylurea therapy INCLUSION CRITERIA: aged 30–80 years; type 2 diabetic patients according to diagnostic criteria of the WHO, FPG 7–15 mmol/L and HbA1c > 7.5%; who had been stable on sulfonylurea therapy for at least 2 months before the screening EXCLUSION CRITERIA: other severe medical problems and severe microvascular complications requiring immediate medical attention DIAGNOSTIC CRITERIA: WHO CO‐MORBIDITIES: not stated CO‐MEDICATIONS: not stated | |
Interventions | NUMBER OF STUDY CENTRES: not stated (1) COUNTRY/ LOCATION: Taiwan SETTING: not stated INTERVENTION (DOSE/DAY): rosiglitazone 4 mg/day (2mg b.i.d.) + sulfonylureas CONTROL (DOSE/DAY): placebo (twice daily) + sulfonylureas TREATMENT BEFORE STUDY: who had been stable on sulfonylurea therapy for at least 2 months before the screening TITRATION PERIOD: | |
Outcomes | PRIMARY OUTCOMES: not stated (plasma levels of adiponectin) SECONDARY OUTCOMES: (not stated) HbA1c; body weight, height, blood pressure, heart rate, plasma glucose, total cholesterol, triglycerides, HOMA | |
Notes | AIM OF STUDY: to assess whether adiponectin levels might increase in type 2 diabetes patients treated with rosiglitazone | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | B ‐ Unclear |
ACE = angiotensin converting enzyme; ADA = American Diabetes Association; ALT = alanine aminotransferase; AST = aspartate aminotransferase; AT II = angiotensin II; b.(i.)d. = bis in die, twice daily; BMI = body mass index (kg/m2); BP = blood pressure; C = control group; CRP = C‐reactive protein; CVD = cardiovascular disease; ECG = electrocardiogram; FCBG = fasting capillary blood glucose; FPG = fasting plasma glucose; HbA1c = glycosylated haemoglobin A1c; HOMA = homeostasis model assessment (of insulin sensitvity); I = intervention group; ITT = intention‐to‐treat; NDDG = National Diabetes Data Group; NYHA = New York Heart Association; OAD = oral antidiabetic drug: OAM = oral antidiabetic medication; o.d. = once daily; PPAR = peroxisome proliferator activated receptor; PPG = postprandial glucose; q.d. = quaque die, once a day; SU = sulfonylureas; t.i.d. = ter in die, three times daily; TZD = thiazolidinediones ("glitazones"); U = Unit; WHO = World Health Organization