Characteristic	Zinman 1999	Chatterjee 2007	Robertson 2007	Rossetti 2003	Vague 2003
Intervention 1 (I1) / intervention 2 (I2) / control 1 (C1)	I1: Ultralente + Lispro C1: NPH + Lispro	I1: Determir + Aspart C1: NPH + Aspart	I1: Determir + Aspart C1: NPH + Aspart	I1: Glargine dinnertime + Lispro I2: Glargine bedtime + Lispro C: NPH + Lispro	I1: Detemir + Aspart C; NPH + Aspart
Randomised controlled clinical trial (RCT)	Y	Y	Y	Y	Y
Non‐inferiority / equivalence trial	Y	Y	Y	Y	Y
Controlled clinical trial	Y	Y	Y	Y	Y
Design: parallel, crossover, factorial RCT	Parallel	Crossover	Parallel	Parallel	Parallel
Crossover study: wash‐out phase	NA	N	NA	NA	NA
Crossover study: carryover effect tested	NA	N	NA	NA	NA
Method of randomisation	?	Y (sealed envelopes)	Y (central telephone system)	?	Y (interactive voice response system)
Unit of randomisation (individuals, cluster ‐ specify)	Individual	Individual	Blocks of three (2:1)	Individual	Individual
Randomisation stratified for centres	N	NA	N	N	N
Randomisation ratio	1:1	1:1	2:1	1:1:1	2:1
Concealment of allocation	?	?	?	?	?
Stated blinding (open; single, double, triple blind)	Double blind	Open label	Open label	Not stated	Open
Actual blinding: participant	Y	N	N	N	N
Actual blinding: caregiver / treatment administrator	Y	N	N	N	N
Actual blinding: outcome assessor	?	?	?	?	?
Actual blinding: others	?	?	?	?	?
Blinding checked: participant	?	NA	NA	NA	NA
Blinding checked: caregiver / treatment administrator	?	NA	NA	NA	NA
Primary endpoint defined	N	Y	Y	Y	Y
[n] of primary endpoint(s)	?	1	1	1	1
[n] of secondary endpoints	?	8	3	7	4
Total [n] of endpoints	5	9	4	8	5
Prior publication of study design	N	N	N	N	N
Outcomes of prior / current publication identical	NA	NA	NA	NA	NA
Power calculation	?	Y	Y	Y	?
[n] participants per group calculated	N	59	Total 270	Total 51	NA
Non‐inferiority trial: interval for equivalence specified	N	Y	Y	Y	N
Intention‐to‐treat analysis (ITT)	Y	N	Y	?	Y
ITT defined	N	NA	Y	N	Y
Analysis stratified for centres	N	NA	N	NA	N
Missing data: last‐observation‐carried‐forward (LOCF)	?	?	?	?	?
Missing data: other methods	?	?	?	?	?
LOCF defined	?	?	?	?	?
[n] of screened participants (I1/ I2 / C1 / total)	?	?	363	?	448
[n] treated with at least one dose (I1/I2/C1/Total)	87/91/178	57/57/57	232/115/347	51	301/146/447
[n] of participants finishing the study	87/91/178	53/55	226/109/335	?	284/141/425
[n] of patients analysed	87/91/178	53/55	232/115/347	?	301/146/447
Description of discontinuing participants	N	Y	Y	N	Y
Drop‐outs (reasons explained)	N	Y	Y	N	Y
Withdrawals (reasons explained)	N	Y	Y	N	Y
Losses‐to‐follow‐up (reasons explained)	N	Y	Y	N	Y
[n] of participants who discontinued	0/0/0	4/2	6/6/12	?	17/5/22
[%] discontinuation rate	0%/0%/0%	6%/3%	2.5%/5.5%/3.4%	?	5.4% / 3.4%
Discontinuation rate similar between groups	Y	Y	y	?	Y
[%] crossover between groups	?	?	?	?	?
[n] of subgroups	1	0	0	2	0
Subgroups: pre‐defined	?	NA	NA	Y	NA
Subgroups: post‐hoc	?	NA	NA	NA	NA
Adjustment for multiple outcomes / repeated measurements	NA	NA	NA	NA	NA
Baseline characteristics: clinically relevant differences	N	N	N	N	N
Treatment identical (apart from intervention)	?	?	?	?	?
Timing of outcomes' measurement comparable between groups	Y	Y	Y	Y	Y
Compliance measured	N	N	N	N	N
Other important covariates measured (specify)	N	N	N	N	N
Co‐morbidities measured	N	N	N	N	N
Co‐medications measured	N	N	N	N	N
Specific doubts about study quality	Y (no description of dropouts)	Y (no ITT)	N	Y (no ITT, no description of drop‐outs)	N
Funding: commercial	Y (m/p)	Y	Y	N	Y
Funding: non‐commercial	?	N	N	Y (National ministry of scientific research and university of Perugia)	N
Publication status: peer review journal	Y	Y	Y	Y	Y
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
Single/multi‐center	?	Single	Multi	Single	Multi
Countries	Canada	UK	Europe	Italy	?
Diagnostic criteria for DM1 defined	N	N	N	N	N
Diagnostic criteria adequate	N	N	N	N	N
Langauge of publication	English	English	English	English	English
Symbols & abbreviations: Y = yes; N = no; ? = unclear I = intervention; C = control