Trial	Intervention(s) and comparator(s)	Randomised/Safety (N)	Hypoglycaemic episodes, severe nocturnal (n/N (%))	Hypoglycaemic episodes, SAE (n/N (%))	Hypoglycaemic episodes, nocturnal (n/N (%))	Hyperglycaemic/ketoacidotic episodes (n/N (%))
Ferguson 2001	I: lispro	39/35	‐	‐	‐	‐
	C: RHI		‐	‐	‐	‐
Home 2000	I: aspart	708/707	54/707 (8)	‐	‐	3/707 (0)
	C: RHI	362/358	39/358 (11)	‐	‐	3/358 (1)
Iwamoto 2001	I: aspart	145a/143	‐	‐	‐	‐
	C: RHI	64b/62	‐	‐	‐	‐
Provenzano 2001	I: lispro	12/12	‐	‐	‐	‐
	C: RHI		‐	‐	‐	‐
Raskin 2000c	I: aspart	597/596	‐/‐ (4)	‐	‐	2/596 (0)d
	C: RHI	287/286	‐/‐ (8)	‐	‐	2/286 (1)d
Recasens 2003	I: lispro	22/22	0/22 (0)	‐	‐	‐
	C: RHI	23/23	0/23 (0)	‐	‐	‐
Z011 2007	I: lispro	81/81	‐	‐	‐	Ketoacidosis: 0/81 (0) Other: 0/81 (0)
	C: RHI	86/86	‐	‐	‐	Ketoacidosis: 2/86 (2) Other: 0/86 (0)
Z013 2007	I: lispro	81/81	‐	‐	‐	Ketoacidosis: 0/81 (0) Other: 0/81 (0)
	C: RHI	88/88	‐	‐	‐	Ketoacidosis: 0/88 (0) Other: 2/88 (2)
Z015 2007	I: lispro	50/50	‐	‐	‐	Ketoacidosis: 1/50 (2) Other: 0/50 (0)
	C: RHI	48/48	‐	‐	‐	Ketoacidosis: 0/48 (0) Other: 0/48 (0)
aTwo participants not exposed to treatment bOne participant not exposed to treatment, one participant removed because of protocol violation cAccording to original study report, 884 participants were randomised, but only 882 received treatment (IQWIG 2007) dOnly ketoacidotic events "‐" denotes not reported C: comparator; I: intervention; RHI: regular human insulin