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 |