Goldberg 2005.
| Methods | DURATION OF INTERVENTION: 24 weeks DURATION OF FOLLOW‐UP: 24 weeks RUN‐IN PERIOD: oral placebo; single‐blind; 4 weeks LANGUAGE OF PUBLICATION: English | |
| Participants | WHO PARTCIPATED: patients with type 2 diabetes mellitus who were treated with diet alone or oral monotherapy INCLUSION CRITERIA: men or women >= 35 years of age with a diagnosis of type 2 diabetes (WHO) with fasting triglyceride levels >= 150 mg/dl and< 600 mg/dl and fasting LDL cholesterol levels < 130 mg/dl; fasting serum C‐peptide levels >= 1 ng/ml and HbA1c values >= 7 and <= 11% if naive to previous oral antihyperglycemic therapy or HbA1c values >= 7 and <= 9.5% if previously treated with oral antihyperglycemic monotherapy. EXCLUSION CRITERIA: treatment within 60 days of screening with insulin, systemic glucocorticoid therapy; combination oral antihyperglycemic therapy, any lipid‐lowering agent, or any weight loss agent; known allergy to any thiazolidinedione; serum creatinine >= 176.8 µmol/dl (>= 2.0 mg/dl) or 2+ dipstick proteinuria at screening; ALT or AST >= 1.5 times the upper limit of normal or significant clinical liver disease; hemoglobin < 10.5 g/dl (females) or < 11.5 g/dl (males) at screening; abnormal thyrotropin; functional NYHA class III or IV, history of CVD, or heart surgery within 6 months of screening; receiving renal dialysis or having renal transplant; current therapy for malignancy other than basal cell or squamous cell skin cancer; known history of HIV infection; signs or symptoms of drug or alcohol abuse; any condition or situation precluding adherence to and completion of the protocol. For female subjects, appropriate birth control was required, and pregnancy, breast‐feeding, or the intent to become pregnant during the study period prohibited participation. DIAGNOSTIC CRITERIA: WHO CO‐MORBIDITIES: control vs intervention: ‐ pre‐existing CVD or previous myocardial infarction 8.4% vs 6.6% CO‐MEDICATIONS: not stated | |
| Interventions | NUMBER OF STUDY CENTRES:
100 (USA 78)
COUNTRY/ LOCATION:
USA, Puerto Rico, Mexico, Colombia
SETTING:
not stated
INTERVENTION (DOSE/DAY):
rosiglitazone 4 mg daily for 12 weeks; thereafter 4 mg twice daily (8 mg/day) for 12 weeks
CONTROL (DOSE/DAY):
pioglitazone 30 mg daily for 12 weeks; thereafter 45 mg once daily for 12 weeks
TREATMENT BEFORE STUDY:
participants discontinued any current oral antihyperglycaemic treatment 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 ‐ pioglitazone: 30 mg daily for 12 weeks; thereafter 45 mg once daily for 12 weeks ‐ rosiglitazone: 4 mg daily for 12 weeks; thereafter 4 mg twice daily (8 mg/day) for 12 weeks |
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| Outcomes | PRIMARY OUTCOMES: triglycerides change from baseline to the last observed value SECONDARY OUTCOMES: total cholesterol; plasma glucose; free fatty acids; apolipoprotein B; total insulin; C‐peptide; highly sensitive C‐reactive protein; plasminogen activator inhibitor‐1 (PAI‐1); HDL‐C; LDL‐C particle size and concentration; surrogates of insulin resistance and beta‐cell function (HOMA); safety assessments including adverse events, body weight, pedal oedema and hypoglycaemic episodes | |
| Notes | AIM OF STUDY: to test the hypothesis that pioglitazone has greater triglyceride‐lowering effects than rosiglitazone ‐ comparison of maximally effective monotherapy doses of pioglitazone and rosiglitazone in patients with type 2 diabetes and dyslipidemia receiving no concomitant glucose‐lowering or lipid‐lowering therapies | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment? | Unclear risk | B ‐ Unclear |