Characteristic	Murphy 2003	Pieber 2000	Porcellati 2004	Raskin 2000	Ratner 2000	Rosenstock 2000	Russell‐Jones 2004	Schober 2001	Tunbridge 1989
Intervention 1 (I1) / intervention 2 (I2) / control 1 (C1)	I1: Glargine + Lispro C1: NPH + HI	I1: Glargine 30 + HI I2: Glargine 80 + HI I3: NPH + HI	I1: Glargine + Lispro I2: NPH + Lispro	I1: Glargine + Lispro I2: NPH + Lispro	I1: Glargine + HI C1: NPH + HI	I1: Glargine 30 + HI I2: Glargine 80 + HI I3: NPH + HI	I1: Determir + HI C1: NPH + HI	I1: Glargine + HI C1: NPH + HI	I1: Ultralente + HI C1: Lente + HI
Randomised controlled clinical trial (RCT)	Y	Y	Y	Y	Y	Y	Y	Y	Y
Non‐inferiority / equivalence trial	Y	Y	Y	Y	Y	Y	Y	Y	Y
Controlled clinical trial	Y	Y	Y	Y	Y	Y	Y	Y	Y
Design: parallel, crossover, factorial RCT	Crossover	Parallel	Parallel	Parallel	Parallel	Parallel	Parallel	Parallel	Crossover
Crossover study: wash‐out phase	N	NA	NA	NA	NA	NA	NA	NA	N
Crossover study: carryover effect tested	N	NA	NA	NA	NA	NA	NA	NA	N
Method of randomisation	?	?	Y (computer generated randomization)	Y (telephone)	?	?	?	?	Y (code prepared elsewhere)
Unit of randomisation (individuals, cluster ‐ specify)	Individual	Individual	Individual	Individual	Individual	Individual	Individual	Individual	Individual
Randomisation stratified for centres	N	N	N	N	N	N	N	N	N
Randomisation ratio	1:1	1:1:1	1:1	1:1	1:1	1:1:1	2:1	1:1	1:1
Concealment of allocation	?	?	Y	?	?	?	?	?	?
Stated blinding (open; single, double, triple blind)	Open	Partially open	?	Open	Open	Partially open	Open	Open	Double blind
Actual blinding: participant	N	N (double blind between glargine groups)	N	N	N	N (double blind between glargine groups)	N	N	Y
Actual blinding: caregiver / treatment administrator	N	N (double blind between glargine groups)	?	N	N	N (double blind between glargine groups)	N	N	Y
Actual blinding: outcome assessor	?	?	?	?	?	?	?	?	?
Actual blinding: others	?	?	?	?	?	?	?	?	?
Blinding checked: participant	NA	NA	NA	NA	NA	NA	NA	NA	?
Blinding checked: caregiver / treatment administrator	NA	NA	NA	NA	NA	NA	NA	NA	?
Primary endpoint defined	Y	N	Y	N	N	Y	N	Y	N
[n] of primary endpoint(s)	1	?	1	?	?	1	?	1	?
[n] of secondary endpoints	3	?	5	?	?	8	?	2	?
Total [n] of endpoints	4	8	6	4	5	9	6	3	8
Prior publication of study design	N	N	N	N	N	N	N	N	N
Outcomes of prior / current publication identical	NA	NA	NA	NA	NA	NA	NA	NA	NA
Power calculation	N	N	Y	N	Y	Y	Y	?	N
[n] participants per group calculated	NA	NA	120	N	220/220/440	?	?	?	NA
Non‐inferiority trial: interval for equivalence specified	N	N	Y	N	Y	Y	Y	N	N
Intention‐to‐treat analysis (ITT)	N	?	?	?	Y	Y	Y	?	Y
ITT defined	NA	N	N	N	Y	Y	Y	N	Y
Analysis stratified for centres	N	N	N	N	N	N	N	N	N
Missing data: last‐observation‐carried‐forward (LOCF)	?	?	?	?	Y	?	?	?	?
Missing data: other methods	?	?	?	?	?	?	?	?	?
LOCF defined	N	N	N	N	N	N	N	N	N
[n] of screened participants (I1/ I2 / C1 / total)	47	?	?	?	?	?	?	?	?
[n] treated with at least one dose (I1/I2/C1/Total)	26/26/26	110/113/110/333	61/60/121	310/309/619	264/270/534	82/87/88/257	491/256/747	174/175/349	66/66/66
[n] of participants finishing the study	25/25/25	?	?	295/293/588	233/248/481	82/87/87/256	465/235/700	?	65/65/65
[n] of patients analysed	25/25/25	?	?	?	?	?	491/256/747	?	66/66/66
Description of discontinuing participants	Y	N	N	Partial	Y	Y	Y	N	Y
Drop‐outs (reasons explained)	Y	N	N	Y	Y	Y	Y	N	Y
Withdrawals (reasons explained)	Y	N	N	N	Y	Y	Y	N	Y
Losses‐to‐follow‐up (reasons explained)	Y	N	Y	N	Y	Y	Y	N	Y
[n] of participants who discontinued	1/0	?	?	15/16/31	31/22/53	0/0/1/1	26/21/47	?	1/0/1
[%] discontinuation rate	4%	?	?	4.8%/5.1?/5%	11.7%/8.1%	0%/0%/1.2%	5.4%/8.2%	?	1.5%/0%/1.5%
Discontinuation rate similar between groups	Y	?	?	Y	Y	Y	Y	?	Y
[%] crossover between groups	?	?	?	?	?	?	?	?	?
[n] of subgroups	0	0	0	0	0	2	0	2	2
Subgroups: pre‐defined	NA	NA	NA	NA	NA	?	NA	2	0
Subgroups: post‐hoc	NA	NA	NA	NA	NA	?	NA	0	1
Adjustment for multiple outcomes / repeated measurements	NA	NA	NA	NA	NA	NA	NA	NA	NA
Timing of outcomes' measurement comparable between groups	Y	Y	Y	Y	Y	Y	Y	Y	Y
Compliance measured	N	N	N	N	N	N	N	N	N
Other important covariates measured (specify)	N	N	N	N	N	N	N	N	N
Co‐morbidities measured	N	N	N	N	N	N	N	N	N
Co‐medications measured	N	N	N	N	N	N	N	N	N
Specific doubts about study quality	N	Y (dropouts not defined)	Y (dropouts not defined)	Y (dropouts not defined)	N	N	N	Y (dropouts and ITT not defined)	N
Funding: commercial	Y	Y	N	Y	Y	Y	Y	Y	Y
Funding: non‐commercial	N	N	National ministry of scientific research and the University of Perugia	N	N	N	N	N	N
Publication status: peer review journal	Y	Y	Y	Y	Y	Y	Y	Y	Y
Publication status: journal supplement	N	N	N	N	N	N	N	N	N
Publication status: abstract	N	N	N	N	N	N	N	N	N
Publication status: other	N	N	N	N	N	N	Presented in the 38th annual meeting of the European Association for the Study of Diabetes (2002)	Published as a letter.	N
Single/multi‐center	Single	Multi	Single	Multi (60)	Multi (49)	Multi	Multi (92)	Multi	Multi (4)
Countries	UK	Europe	Italy	?	?	?	Europe + Australia	?	UK
Diagnostic criteria for DM1 defined	N	N	N	N	N	N	N	N	N
Diagnostic criteria adequate	NA	NA	NA	NA	NA	NA	NA	NA	NA
Langauge of publication	English	English	English	English	English	English	English	English	English