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. 2007 Jul 18;2007(3):CD006063. doi: 10.1002/14651858.CD006063.pub2
Characteristic Garber 2006 Goldberg 2005 Hanefeld 2007 Hällsten 2002 Jung 2005
Intervention 1 (I1) / intervention 2 (I2) / control 1 (C1) I1: rosiglitazone + metformin 
 C1: glibenclamide + metformin I1: pioglitazone 
 C1: rosiglitazone I1: rosiglitazone 4 mg + placebo 
 I2: rosiglitazone 8 mg + placebo 
 C1: glibenclamide + placebo I1: rosiglitazone 
 I2: metformin 
 C1: placebo I1: rosiglitazone + glimipiride 
 C1: metformin + glimipiride
Randomised controlled clinical trial (RCT) Y Y Y Y Y
Non‐inferiority / equivalence trial N N Y N N
Controlled clinical trial N N N N N
Design: parallel study Y Y Y Y Y
Design: crossover study N N N N N
Design: factorial study N N N N N
Crossover study: wash‐out phase NA NA NA NA NA
Crossover study: carryover effect tested NA NA NA NA NA
Crossover study: period effect tested NA NA NA NA NA
Method of randomisation ? stratified for being previously treated with oral antidiabetic drugs and according to sex ? ? ?
Unit of randomisation (individuals, cluster ‐ specify) individuals individuals individuals individuals individuals
Randomisation stratified for centres ? N ? ? ?
Randomisation ratio 1:1 1:1 1:1:1 1:1 1:1
Concealment of allocation ? ? ? ? ?
Stated blinding (open; single, double, triple blind) double‐blind double‐blind double‐blind, double‐dummy double‐blind ?
Actual blinding: participant Y ? Y Y NA
Actual blinding: caregiver / treatment administrator ? ? ? ? NA
Actual blinding: outcome assessor ? ? ? ? NA
Actual blinding: others ? ? ? ? NA
Blinding checked: participant N N N N NA
Blinding checked: caregiver / treatment administrator N N N N NA
Primary endpoint defined (power calculation) Y Y Y N N
[n] of primary endpoint(s) 1 1 1 ? ?
[n] of secondary endpoints 7 16 13 ? ?
Total [n] of endpoints 8 17 14 13 10
Prior publication of study design N N N N N
Outcomes of prior/current publication identical NA NA NA NA NA
Power calculation Y N Y N N
[n] participants per group calculated 150 NA ? NA NA
Non‐inferiority trial: interval for equivalence specified NA NA Y NA NA
Intention‐to‐treat analysis (ITT) Y Y Y ? ?
Per‐protocol‐analysis N Y ? ? ?
ITT defined Y Y Y NA NA
Missing data: last observation carried forward (LOCF) ? Y Y N N
Missing data: Other methods N N N N N
LOCF defined NA N N NA NA
Analysis stratified for centres N N ? N N
[n] of screened patients (I1 / I2/ C1/ total) total: 356 total: 4410 total: 662 ? ?
[n] of randomised participants (I1/ I2 / C1 / total) ‐ primary endpoint I1: 158 
 C1: 160 
 total: 318 I1: 369; 
 C1: 366; 
 total: 735 I1: 200 
 I2: 191 
 C1: 207 
 total: 598 I1: 15 
 I2: 16 
 C1: 14 
 total: 45 I1: 15 
 C1: 15 
 total: 30
[n] of participants finishing the study (I1/ I2 / C1 / total) I1: 133 
 C1: 131 
 total: 264 I1: 299 
 C1: 286 
 total: 585 I1: 153 
 I2: 158 
 C1: 173 
 total: 484 I1: 14 
 I2: 13 
 C1: 14 
 total: 41 I1: 14 
 C1: 13 
 total: 27
[n] of participants analysed (I1/ I2 / C1 / total) ‐ primary endpoint I1: 
 C1: 
 total: 305 I1: 363 
 C1: 356 
 total: 719 I1: 195 
 I2: 189 
 C1: 202 
 total: 586 
 (ITT population) I1: 14 
 I2: 13 
 C1: 14 
 total: 41 I1: 14 
 C1: 13 
 total: 27
Description of discontinuing participants N Y Y N N
Drop‐outs (reasons explained) Y Y ? N Y
Withdrawals (reasons explained) Y Y Y Y N
Losses‐to‐follow‐up (reasons explained) ? Y ? N N
[n] of participants who discontinued (I1/ I2 / C1 / total) I1: 25 
 C1: 29 
 total: 54 I1: 70 
 C1: 80 
 total: 150 I1: 47 
 I2: 33 
 C1: 34 
 total: 114 I1: 1 
 I2: 3 
 C1: 0 
 total: 4 I1: 1 
 C1: 2 
 total: 3
[%] discontinuation rate (I1/ I2 / C1 / total) I1: 16 
 C1: 18 
 total: 17 I1: 19 
 C1: 22 
 total: 20 I1: 23.5 
 I2: 17.3 
 C1: 16.4 
 total: 19 I1: 7 
 I2: 19 
 C1: 0 
 total: 9 I1: 7 
 C1: 13 
 total: 10%
Discontinuation rate similar between groups N Y N ? Y
[%] crossover between groups ? ? ? ? ?
Differences [n] calculated to analysed patients N NA ? NA NA
Adjustment for multiple outcomes / repeated measurements N N N N N
Baseline characteristics: Clinically relevant differences Y 
 9% more men in I1 than C N N 
 rosiglitazone 8 mg less male participants) ? 
 HbA1c not included in baseline characteristics ? 
 HbA1c and resistin not included in baseline characteristics
Treatment identical (apart from intervention) Y Y Y Y Y
Compliance measured N N N Y N
Other important covariates measured (specify) N N N N N
Co‐morbidities measured N Y N N N
Co‐medications measured N N N N N
Specific doubts about study quality N N N N N
Funding: commercial Y Y Y Y N
Funding: non‐commercial ? ? N Y Y
Publication status: peer review journal N Y Y Y N
Publication status: journal supplement N N N N N
Publication status: abstract N N N N N
Publication status: other N N N N N
Notes commercial funding not explicitly stated but three of five authors from pharmaceutical company no quantitative data on adverse events sample size not reported, LOCF parameter unclear, baseline no of participants 587 patients received written diet instructions poor reporting on quality criteria
           
Footnotes
Y = yes; N = no; ? = unclear I = intervention; C = control; (baseline) = if numbers for certain features could ne be derived from the text, numbers from baseline characteristics were used