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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) Hypoglycaemic episodes, severe nocturnal (n/N (%)) Hypoglycaemic episodes, SAE (n/N (%)) Hypoglycaemic episodes, nocturnal (n/N (%)) Hyperglycaemic/ketoacidotic episodes (n/N (%))
Altuntas 2003 I: insulin lispro 20
C: RHI 20
Bastyr 2000 I: insulin lispro 186 3/186 (2)
C: RHI 189 3/189 (2)
Dailey 2004 I: insulin glulisine ‐/435 89/416a,b
C: RHI ‐/441 103/420a,b
All 878c/876 192/836a,b
Hermann 2013 I: insulin aspart 18
C: RHI 11
NCT01650129 I: biphasic insulin aspart 50 58
C: biphasic human insulin 50/50 26
Pfützner 2013 I1: insulin aspart 4
I2: insulin glulisine 4
C: RHI 4
Rayman 2007 I: insulin glulisine 448 3/‐d (1) 95/‐d (21)
C: RHI 444c/442 5/‐d (1) 100/‐d (23)
Ross 2001 I: insulin lispro 70
C: RHI 78
Z012 1997 I: insulin lispro 72 0/72 (0)
C: RHI 73 1/73 (1)
Z014 1997 I: insulin lispro 73 1/73 (1)
C: RHI 77 1/77 (1)
aBased on author's response in IQWIG 2005
bOnly for the period month 4 to study end
cTwo participants not exposed to treatment
dAccording 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.
—: denotes not reported
C: comparator; I: intervention; RHI: regular human insulin; SAE: serious adverse events