Stocker 2007.
Methods | DURATION OF INTERVENTION: 24 weeks DURATION OF FOLLOW‐UP: 24 weeks RUN‐IN PERIOD: none LANGUAGE OF PUBLICATION: English | |
Participants | WHO PARTCIPATED: type 2 diabetes patients with suboptimally controlled diabetes mellitus INCLUSION CRITERIA: between 21 and 80 years of age, with a glycosylated hemoglobin level above 7.0% during treatment with either diet modification or sulfonylurea monotherapy EXCLUSION CRITERIA: known inflammatory diseases (including inflammatory bowel disease, vasculitis, and rheumatologic disease), insulin use, corticosteroid use, an infection within 1 month of enrollment, glomerular filtration rate < 60 ml/min, pregnancy, known history of myocardial infarction or congestive heart failure, secondary diabetes (including Cushing’s syndrome and acromegaly), hypersensitivity to metformin or rosiglitazone, or a history of carotid endarterectomy DIAGNOSTIC CRITERIA: not stated CO‐MORBIDITIES: known cardiovascular disease [no (%)] I1: 2 (4.4%) C1: 3 (6.4%) CO‐MEDICATIONS: statin use [no (%)]: I1: 24 (53.3%) C1: 23 (48.9%) aspirin use [no (%)] : I1: 21 (46.7%) C1: 28 (59.6%) beta‐blocker use [no (%)]: I1: 8 (17.8%) C1: 7 (14.9%) calcium‐channel blocker use [no (%)]: I1: 6 (13.3%) C1: 13 (27.7%) angiotensin receptor blocker use [no (%)]: I1: 2 (4.4%) C1: 0 (0%) ACE inhibitor use [no (%)]: I1: 23 (51.1%) C1: 30 (63.8%) sulfonylurea use [no (%)]: I1: 34 (75.6%) C1: 34 (72.3%) | |
Interventions | NUMBER OF STUDY CENTRES:
1
COUNTRY/ LOCATION:
USA
SETTING:
Diabetes Institute of theWalter Reed Army Medical Center, Washington DC, USA
INTERVENTION (DOSE/DAY):
rosiglitazone 4 mg o.d.
CONTROL (DOSE/DAY):
metformin 850 mg b.i.d.
TREATMENT BEFORE STUDY:
diet modification or sulfonylurea monotherapy
TITRATION PERIOD:
other concurrent therapies (sulfonylurea, antihypertensive, or
statin medications) were continued at stable doses during the study nutrition counseling and diabetes education was offered to all participants at enrollment, in addition to their study medication |
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Outcomes | PRIMARY OUTCOMES:
change in C‐reactive protein (CRP) levels after 24 weeks between the metformin and rosiglitazone treatment groups
SECONDARY OUTCOMES:
the predefined secondary
end point was the change in mean and maximal CIMT of the common carotid artery further outcomes: FPG, HbA1c, lipids, weight, carotid intima media thickness (CIMT) |
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Notes | AIM OF STUDY: to compare the effects of rosiglitazone and metformin on C‐reactive protein (CRP) and carotid intima media thickness (CIMT) | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | B ‐ Unclear |