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. 2018 Dec 17;2018(12):CD013228. doi: 10.1002/14651858.CD013228
Trial ID Intervention(s) and comparator(s) Randomised / safety (N) Deaths
(n/N) All adverse events
 (n/N (%)) Severe, serious adverse events
 (n/N (%)) Attrition due to adverse events
 (n/N (%)) All hypoglycaemic episodes (n/N (%)) Severe hypoglycaemic episodes (n/N (%))
Altuntas 2003 I: insulin lispro 20 0/20
C: RHI 20 0/20
Bastyr 2000 I: insulin lispro 186 2/186 2/186 (1)a 3/186 (2) b c
C: RHI 189 0/189 0/189 (0)a 4/189 (2) b c
Dailey 2004 I: insulin glulisine ‐/435 1/435 358/435 (82) 55/435 (13) 5/435 (1) 317/435 (73)d 6/416 (1)d,e
C: RHI ‐/441 2/441 351/441 (80) 51/441 (12) 6/441 (1) 322/441 (73)d 5/420 (1)d,e
all: 878f/876 3/876 709/876 (81) 106/876 (12) 11/876 (1) 639/876 (73)d 11/836d,e
Hermann 2013 I: insulin aspart 18 g h i
C: RHI 11 g h i
NCT01650129 I: biphasic insulin aspart 50 58 0/58 53/58 (91) 5/58 (9) 2/58 (3) 40/58 (69) 2/58 (3)j
C: biphasic human insulin 50/50 26f/25 0/25 22/25 (88) 1/25 (4) 1/25 (4) 16/25 (64) 1/25 (4)
Pfützner 2013 I1: insulin aspart 4 g
I2: insulin glulisine 4 g
C: RHI 4 g
Rayman 2007 I: insulin glulisine 448 2/448 260/448 (58) 43/448 (10)k 9/448 (2) 140l/‐m (33) 6/‐n (1)
C: RHI 444o/442 1/442 260/442 (59) 52/442 (12)k 3/442 (1) 144l/‐m (33) 14/‐n (3)
All 892/890 3/890 520/890 (58) 95/890 (11)k 12/890 (1) 284/‐ (33) 20/‐ (‐)
Ross 2001 I: insulin lispro 70 1/148 (1)
C: RHI 78
Z012 1997 I: insulin lispro 72 0/72 0/72 (0) 0/72 (0) p q
C: RHI 73 0/73 0/73 (0) 1/73 (1) p q
Z014 1997 I: insulin lispro 73 0/73 3/73 (4) 3/73 (4) r s
C: RHI 77 0/77 0/77 (0) 3/77 (4) r s
aExcluding hyper‐ and hypoglycaemic events bEvents/participant/30 days (mean ± standard deviation) at study end: 0.9 ± 2.1 (lispro) vs 0.8 ± 1.9 (RHI); P = 0.39 cInconsistent with other numbers presented in the same table in NCT01650129
dBased on author's response in IQWIG 2005 eOnly for the period month 4 to study end fOne participant did not receive treatment
gNot explicitly reported, but likely zero hNot explicitly reported, but the results sections leads us to assume that there were no dropouts iNumber of participants with up to three episodes per year: aspart: 5/18, RHI: 3/11 jRHI: coma: 2 participants; IV glucose: 1 participant, glucagon: 1 participant; lispro: coma: 0 participants, IV glucose: 1 participant, glucagon: 1 participant kInconsistent with information from IQWIG 2005: serious adverse events (other than severe hypo‐ and hyperglycaemia): 38 (8.5%) and 40 (9.0%); adding the number of serious hypoglycaemia (6 and 14) to these numbers results in a higher number than what was reported in Rayman 2007 lMonths 4 to 6 only, according to IQWIG 2005, 226 (glulisine) and 240 (RHI) participants with at least one episode over a period of 6 months mThe number of participants presented in table 4 of the publication cannot be correct (Rayman 2007) nAccording to IQWIG 2005, the total number of participants should be 448 and 442 (deducted from percentage numbers presented in the original study report), but in the same table, it is also reported that there are 21 and 8 missing values oTwo participants did not receive treatment pEvents/participant/30 days (mean ± standard deviation) at study end: 2.1 ± 3.2 (lispro) vs 2.5 ± 4.6 (RHI); P = 0.51
qRHI: coma: 1 participant; IV glucose: 2 participants, glucagon: 0 participants; lispro: coma: 1 participant, IV glucose: 2 participants, glucagon: 0 participants rEvents/participant/30 days (mean ± standard deviation) at study end: 0.8 ± 2.3 (lispro) vs 0.8 ± 2.1 (RHI); P = 0.65 sRHI: coma: 2 participants; IV glucose: 1 participant, glucagon: 0 participants; lispro: coma: 1 participant, IV glucose: 1 participant, glucagon: 0 participants
—: denotes not reported C: comparator; I: intervention; RHI: regular human insulin; IV: intravenous