Characteristic	Derosa 2004	Derosa 2006a	Derosa 2006b
Intervention 1 (I1) / intervention 2 (I2) / control 1 (C1)	I1: rosiglitazone + glimepiride C1: pioglitazone + glimepiride	I1: rosiglitazone + metformin C1: pioglitazone + metformin	I1: rosiglitazone + metformin C1: glimepiride + metformin
Randomised controlled clinical trial (RCT)	Y	Y	Y
Non‐inferiority / equivalence trial	N	N	N
Controlled clinical trial	N	N	N
Design: parallel study	Y	Y	Y
Design: crossover study	N	N	N
Design: factorial study	N	N	N
Crossover study: wash‐out phase	NA	NA	NA
Crossover study: carryover effect tested	NA	NA	NA
Crossover study: period effect tested	NA	NA	NA
Method of randomisation	randomisation codes prepared by statistician	?	drawing of envelopes; randomisation codes prepared by a statistician
Unit of randomisation (individuals, cluster ‐ specify)	individuals	?	individuals
Randomisation stratified for centres	?	?	?
Randomisation ratio	1:1	1:1	1:1
Concealment of allocation	envelopes; a copy of the randomisation code was provided only to the statistician	envelopes containing randomisation code; a copy of the randomisation code was provoided only for the statistician	?; drawing of envelopes
Stated blinding (open; single, double, triple blind)	double‐blind	double‐blind	double‐blind
Actual blinding: participant	Y	Y	Y
Actual blinding: caregiver / treatment administrator	?	?	?
Actual blinding: outcome assessor	?	?	?
Actual blinding: others	?	?	?
Blinding checked: participant	N	N	N
Blinding checked: caregiver / treatment administrator	N	N	N
Primary endpoint defined (power calculation)	N	N	Y
[n] of primary endpoint(s)	6	5	5
[n] of secondary endpoints	?	?	6
Total [n] of endpoints	?	?	11
Prior publication of study design	N	?	N
Outcomes of prior/current publication identical	NA	N	N
Power calculation	N	N	?; see notes for details
[n] participants per group calculated	NA	NA	?; stated but no details provided
Non‐inferiority trial: interval for equivalence specified	NA	NA	NA
Intention‐to‐treat analysis (ITT)	Y	Y	Y
Per‐protocol‐analysis	N	N	N
ITT defined	Y	Y	Y
Missing data: last observation carried forward (LOCF)	?	?	N
Missing data: Other methods	Y Bonferroni	Y Bonferroni	N
LOCF defined	NA	NA	N
Analysis stratified for centres	N	?	N
[n] of screened patients (I1 / I2/ C1/ total)	?	?	?
[n] of randomised participants (I1/ I2 / C1 / total) ‐ primary endpoint	I1: 42 (baseline) C1: 45 (baseline) total: 91	I1: 48 (baseline) C1: 48 (baseline) total: 103	I1: 48 (baseline) C1: 47 (baseline) total: 99
[n] of participants finishing the study (I1/ I2 / C1 / total)	I1: 42 C1: 45 total: 87	I1: 48 C1:48 total: 96	I1: 48 (baseline) C1: 47 (baseline) total: 95
[n] of participants analysed (I1/ I2 / C1 / total) ‐ primary endpoint	I1: 42 C1: 45 total: 87	I1: 48 C1:48 total: 96	?
Description of discontinuing participants	N	N	N
Drop‐outs (reasons explained)	Y	N	N
Withdrawals (reasons explained)	Y	N	Y
Losses‐to‐follow‐up (reasons explained)	N	N	N
[n] of participants who discontinued (I1/ I2 / C1 / total)	I1: 2 C1: 2 total: 4	I1: ? C1: ? total: 7	I1: 2 C1: 2 total: 4
[%] discontinuation rate (I1/ I2 / C1 / total)	I1: 5 C1: 4 total: 4	I1: ? C1: ? total: 6	I1: ? C1: ? total: 4
Discontinuation rate similar between groups	Y	?	Y
[%] crossover between groups	?	?	?
Differences [n] calculated to analysed patients	NA	?	?
Adjustment for multiple outcomes / repeated measurements	Y	see comments	N
Baseline characteristics: Clinically relevant differences	N	N	N
Treatment identical (apart from intervention)	N some patients received behaviour modification, sessions for weight‐loss	Y	Y
Compliance measured	Y pill count	Y pill count	Y pill count
Other important covariates measured (specify)	N	N	N
Co‐morbidities measured	N	N	N
Co‐medications measured	Y	N	Y
Specific doubts about study quality	Y see notes	Y see notes	?
Funding: commercial	?	N	?
Funding: non‐commercial	?	N	?
Publication status: peer review journal	Y	Y	Y
Publication status: journal supplement	N	N	N
Publication status: abstract	N	N	N
Publication status: other	N	N	N
Notes	patients were requested to follow a controlled‐energy diet (ADA); some patients received behaviour modifications for weight‐loss; exercise recommendations were given; co‐medications not specified for intervention vs control	patients were requested to follow a controlled‐energy diet (ADA); patients received behaviour modifications for weight‐loss; exercise recommendations were given; adjustment stated as Bonferroni but P‐values provided show no indication of application of the method; drop‐outs per group not specified	patients were requested to follow a controlled‐energy diet (ADA); all patients received behaviour modifications for weight‐loss; exercise recommendations were given; co‐medication not specified for intervention vs control; publication in Pharmacotherapy 2005 states that a power calculation was performed whereas the publication in Clinical Therapeutics 2005 states that no power calculation was performed
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