| Characteristic | Rosenstock 2006b | Stocker 2007 | Sutton 2002 | Yang 2002 |
| Intervention 1 (I1) / intervention 2 (I2) / control 1 (C1) | I1: rosiglitazone + sulfonylurea + metformin C1: insulin glargine + sulfonylurea + metformin | I1: rosiglitazone C1: metformin | I1: rosiglitazone C1: glyburide | I1: rosiglitazone C1: placebo |
| Randomised controlled clinical trial (RCT) | Y | Y | Y | Y |
| Non‐inferiority / equivalence trial | ? | N | Y | N |
| Controlled clinical trial | N | N | N | N |
| Design: parallel | Y | Y | Y | Y |
| Design: crossover study | N | N | N | N |
| Design: factorial study | N | N | N | N |
| Crossover study: wash‐out phase | NA | NA | NA | NA |
| Crossover study: carryover effect tested | NA | NA | NA | NA |
| Crossover study: period effect tested | NA | NA | NA | NA |
| Method of randomisation | ? | random number generator, stratified by the use of statins | ? | ? |
| Unit of randomisation (individuals, cluster ‐ specify) | ? | individuals | ? | ? |
| Randomisation stratified for centres | ? | NA | ? | ? |
| Randomisation ratio | 1:1 | 1:1 | 1:1 | 1 : 1 |
| Concealment of allocation | ? | "allocation‐concealed randomization" | ? | ? |
| Stated blinding (open; single, double, triple blind) | open | open | open | double‐blind |
| Actual blinding: participant | N | NA | N | Y |
| Actual blinding: caregiver / treatment administrator | N | NA | N | ? |
| Actual blinding: outcome assessor | ? | Y | ? | ? |
| Actual blinding: others | N | N | N | N |
| Blinding checked: participant | NA | NA | NA | N |
| Blinding checked: caregiver / treatment administrator | NA | NA | NA | N |
| Primary endpoint defined (power calculation) | Y | Y | Y | N |
| [n] of primary endpoint(s) | 1 | 1 | 1 | 1 |
| [n] of secondary endpoints | 7 | 2 | 10 | 10 |
| Total [n] of endpoints | 8 | 8 | 11 | 11 |
| Prior publication of study design | N | N | N | N |
| Outcomes of prior/current publication identical | NA | NA | NA | NA |
| Power calculation | N | Y | Y | N |
| [n] participants per group calculated | NA | 40 | 60 | NA |
| Non‐inferiority trial: interval for equivalence specified | NA | NA | Y | NA |
| Intention‐to‐treat analysis (ITT) | Y | N | Y | ? |
| Per‐protocol‐analysis | N | Y | Y | ? |
| ITT defined | Y | NA | Y | N |
| Missing data: last observation carried forward (LOCF) | Y | N | Y | ? |
| Missing data: Other methods | N | N | N | N |
| LOCF defined | N | NA | N | N |
| Analysis stratified for centres | Y | NA | N | ? |
| [n] of screened patients (I1 / I2/ C1/ total) | total: 341 | total: 120 | total: 351 | ? |
| [n] of randomised participants (I1/ I2 / C1 / total) ‐ primary endpoint | I1: ? C1: ? total: 219 | I1: 45 C1: 47 total: 92 | I1: 104 C1: 99 total: 203 | ? |
| [n] of participants finishing the study (I1/ I2 / C1 / total) | I1: ? C1: ? total: ? | I1: ? C1: ? total: | I1: ? C1: ? total: 130 | ? |
| [n] of participants analysed (I1/ I2 / C1 / total) ‐ primary endpoint | I1: 105 C1: 112 total: 216 | I1: 37 C1: 38 total: 75 | I1: ? C1: ? total: ? | I1: 30 C1: 34 total: 64 |
| Description of discontinuing participants | Y | Y | Y | N |
| Drop‐outs (reasons explained) | N | Y | N | N |
| Withdrawals (reasons explained) | Y | Y | Y | N |
| Losses‐to‐follow‐up (reasons explained) | N | NA | N | N |
| [n] of participants who discontinued (I1/ I2 / C1 / total) | I1: 11 C1: 7 total: 18 | I1: 8 C1: 9 total: 17 | I1: 40 C1: 34 total: 74 | I1: ? C1: ? total: ? |
| [%] discontinuation rate (I1/ I2 / C1 / total) | I1: ? C1: ? total: 8 | I1: 17.8 C1: 19.2 total: 18.5 | I1: 38 C1: 34 total: 36 | I1: ? C1: ? total: ? |
| Discontinuation rate similar between groups | Y | Y | Y | ? |
| [%] crossover between groups | ? | ? | ? | ? |
| Differences [n] calculated to analysed patients | NA | N | N | NA |
| Adjustment for multiple outcomes / repeated measurements | N | N | N | ? |
| Baseline characteristics: Clinically relevant differences | Y sex | Y medications, sex | N | N baseline values for adiponectin not reported |
| Treatment identical (apart from intervention) | Y | Y | Y | Y |
| Compliance measured | N | Y patient surveys, prescription renewals, pill counts | N | N |
| Other important covariates measured (specify) | N | N | N | N |
| Co‐morbidities measured | N | Y partly | N | N |
| Co‐medications measured | N | Y | N | N |
| Specific doubts about study quality | Y | N | Y | Y |
| Funding: commercial | Y | Y | ? | Y |
| Funding: non‐commercial | N | N | N | ? |
| Publication status: peer review journal | Y | Y | Y | Y |
| Publication status: journal supplement | N | N | N | N |
| Publication status: abstract | N | N | N | N |
| Publication status: other | N | N | N | N |
| Notes | allocation concealment unclear, blinding of outcome assessor unclear, open design | open design, unclear outcome assessment | one author employed by GlaxoSmithKline | unclear how many patients were randomised, how many discontinued, were withdrawn or lost to follow‐up; efficacy evaluation seems to be published in a different publication; unclear if patients were still randomised under this follow‐up study |
|
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 | ||||
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