1. Overview of study populations.

Characteristic	Intervention(s) and comparator(s)	Sample sizea	Screened/eligible (n)	Randomised (n)	Safety (n)	ITT (n)	Finishing study (n)	Randomised finishing study (%)	Follow‐upb
Ferguson 2001 cross‐over trial	I: insulin lispro	‐	40/39	39	35	33c	34	87	24 weeks
	C: regular human insulin
	total:			39	35	33	34	87
Home 2000	I: insulin aspart	‐	1237/1110	708	707	698	676	96	6 months
	C: regular human insulin			362	358	349	335	94
	total:			1070	1065	1047	1011	94
Iwamoto 2001	I: insulin aspart	‐	146	145d	143	143	136	94	24 weeks
	C: regular human insulin		65	64e	62	62	60	94
	total:			209	205	205	196	94
Provenzano 2001 cross‐over trial	I: insulin lispro	‐	12	12	12	12	12	100	6 monthsf
	C: regular human insulin
	total:			12	12	12	12	100
Raskin 2000	I: insulin aspart	‐	884	597	596	596	552	93	6 monthsh
	C: regular human insulin			287	286	286	263	92
	total:			884g	882	882	815
Recasens 2003	I: insulin lispro	‐	45	22	22	22	‐	‐i	12 months
	C: regular human insulin			23	23	23	‐	‐i
	total:			45	45	45	‐	‐
Z011 2007	I: insulin lispro	‐	‐	81	81	81	74j	91	12 months
	C: regular human insulin			86	86	86	79j	92
	total:			167	167	167	153	92
Z013 2007	I: insulin lispro	‐		81	81	81	75j	93	12 months
	C: regular human insulin			88	88	88	83j	94
	total:			169	169	169	158	93
Z015 2007	I: insulin lispro	‐		50	50	50	45j	90	12 months
	C: regular human insulin			48	48	48	43j	90
	total:			98	98	98	88	90
Grand total	All interventions			1735
	All comparators			1009
	All interventions and comparators			2744k

^aAccording to power calculation in study publication or report
 ^bDuration of intervention or follow‐up (or both) under randomised conditions until end of study
 ^cOne participant who completed the trial was not analysed because of inconsistencies between the home glucose monitoring diary, HbA1c results and the content of the glucose meter memory.^dTwo participants not exposed to treatment
 ^eOne participant not exposed to treatment, one person removed because of protocol violation
 ^fThree months on Mediterranean diet and three months on normal diet
 ^gAccording to original study report, 884 participants were randomised, but only 882 received the treatment
 ^hParticipants were treated with insulin aspart or regular human insulin for six months, but could continue their assigned treatment in a six‐months extension of the study
 ⁱIt was not explicitly stated, but based on the presentation of the results, we assume that all participants finished the study
 ^jBased on number of drop‐outs reported in IQWIG 2007
 ^kParticipants of cross‐over trials were counted both in interventions and comparator groups

"‐" denotes not reported

C: comparator; HbA1c: glycosylated haemoglobin A1c; I: intervention; ITT: intention‐to‐treat