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. 2007 Jul 18;2007(3):CD006063. doi: 10.1002/14651858.CD006063.pub2

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
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)
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