| Methods |
DURATION OF INTERVENTION: 12 months
DURATION OF FOLLOW‐UP:
12 months
RUN‐IN PERIOD: none LANGUAGE OF PUBLICATION: English |
| Participants |
WHO PARTCIPATED:
white patients with type 2 diabetes mellitus and metabolic syndrome
INCLUSION CRITERIA:
white patients of either sex and ages >=18 years; type 2 diabetes according to ADA criteria (duration >=6 months); poor glycaemic control (HbA1c >=7.5% or >=1 adverse effect with diet and oral hypoglycaemic agents (e.g. SU or metformin) given up to the maximum tolerated dose; all patients also diagnosed with metabolic syndrome (National Cholesterol Education Program Adult Treatment Panel III classification; triglyceridaemia (TG >=150 mg/dl) and hypertension (WHO criteria BP >=130/>=85 mmHg); fasting C‐peptide level >1.0 ng/ml
EXCLUSION CRITERIA:
receiving glimepiride, history of ketoacidosis, unstable or rapidly progressive diabetic retinopathy, nephropathy or neuropathy; impaired hepatic function, impaired renal function, severe anaemia; severe cardiovascular disease (e.g. NYHA III or IV congestive heart failure or a history of myocardial infarction or stroke) or cerebrovascular conditions within 6 months before enrolment; women who were pregnant or breastfeeding or of childbearing potential and not taking adequate contraceptive precautions
DIAGNOSTIC CRITERIA:
ADA 2001
CO‐MORBIDITIES:
not stated
CO‐MEDICATIONS:
40.2% receiving antihypertensive drugs; no patient was receiving lipid‐lowering or antiaggregant drugs |
| Interventions |
NUMBER OF STUDY CENTRES:
three
COUNTRY/ LOCATION:
Italy
SETTING:
unclear
INTERVENTION (DOSE/DAY):
rosiglitazone 4 mg once daily (before lunch); +fixed oral dose of glimepiride (4 mg/day divided into 2 doses; before breakfast and before dinner)
CONTROL (DOSE/DAY):
pioglitazone 15 mg once daily (before lunch); + fixed oral dose of glimepiride (4 mg/day divided into 2 doses; before breakfast and before dinner)
TREATMENT BEFORE STUDY:
52.9% poor glycaemic control with metformin; 31% with SUs; 16.1% with glyburide; 14.9% with gliclazide
TITRATION PERIOD:
none |
| Outcomes |
PRIMARY OUTCOMES:
changes in BMI, HbA1c, lipid profile, and lipoprotein variables were the primary efficacy variables SECONDARY OUTCOMES:
fasting and postprandial plasma glucose, insulin levels, insulin resistance (HOMA); blood pressure; adverse events |
| Notes |
AIM OF STUDY:
to assess the differential effect on glucose and lipid variables of the combination of glimepiride plus pioglitazone or rosiglitazone in patients with type 2 diabetes and the metabolic syndrome |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
