| Trial ID | Intervention(s) and comparator(s) | Sex (female %) | Age (mean years (SD)) | HbA1c (mean % (SD)) | BMI (mean kg/m² (SD)) | Co‐medications, Co‐interventions (% of participants) | Comorbidities (% of participants) |
| Altuntas 2003 | I: insulin lispro | — | 55 (34) | 9.4 (1.5) | 31 (‐) | — | — |
| C: RHI | — | 55 (34) | 9.6 (1.4)a | 31 (‐) | — | — | |
| Bastyr 2000 | I: insulin lispro | 43 | 55 (‐) | 9.5 (1.9)b | 28 (‐) | — | — |
| C: RHI | 44 | 57 (‐) | 9.6 (1.8)b | 28 (‐) | — | — | |
| Dailey 2004 | I: insulin glulisine | 44 | 59 (10) | 7.6 (0.9) | 35 (7) | — | — |
| C: RHI | 50 | 58 (10) | 7.5 (1.0) | 35 (7) | — | — | |
| Hermann 2013 | I: insulin aspart | 27 | 58 (12) | 8.7 (1.6) | 31.5 (5.8) | — | — |
| C: RHI | 44 | 60 (9) | 8.7 (1.6) | 32.8 (4.8) | — | — | |
| NCT01650129 | I: biphasic insulin aspart 50 | 41 | 60 (11) | 7.8 (1.2) | 23 (3) | — | — |
| C: biphasic human insulin 50/50 | 20 | 60 (10) | 7.5 (1.6) | 23 (3) | — | — | |
| Pfützner 2013 | I1: insulin aspart | 9 | 64 (9) | 7.1 (0.6) | 32 (5) | — | — |
| I2: insulin glulisine | — | — | |||||
| C: RHI | — | — | |||||
| Rayman 2007 | I: insulin glulisine | 52 | 60 (9) | 7.6 (0.9) | 32 (5)c | Short‐acting insulin: 72 Basal insulin: 60 Mixture insulin: 11 OAD: 34 | — |
| C: RHI | 49 | 60 (10) | 7.5 (0.9) | 31 (5) | Short‐acting insulin: 70 Basal insulin: 63 Mixture insulin: 13 OAD: 34 | — | |
| Ross 2001 | I: insulin lispro | 63 | 59 (8) | 10.7 (1.7) | 28 (8) | — | Retinopathy: 11 Neuropathy: 32 Hypertension and peripheral vascular disease: 11 |
| C: RHI | 62 | 58 (9) | 10.6 (1.6) | 27 (9) | — | ||
| Z012 1997 | I: insulin lispro | 56 | 50 (‐) | 8.7 (1.5) | 29 (‐) | — | — |
| C: RHI | 57 | 44 (‐) | 8.8 (1.8) | 28 (‐) | — | — | |
| Z014 1997 | I: insulin lispro | 56 | 48 (‐) | 8.8 (1.4) | 28 (‐) | — | — |
| C: RHI | 55 | 51 (‐) | 9.0 (1.6) | 29 (‐) | — | — | |
|
a Inconsistency in reporting of HbA1c value between table and text in publication b Measurement 2 weeks after randomisation c According to IQWIG 2005: 31(5), difference possibly due to rounding —: denotes not reported BMI: body mass index; C: comparator; HbA1c: glycosylated haemoglobin A1c; I: intervention; OAD: oral antidiabetic drugs; SD: standard deviation; SU: sulphonylurea drugs | |||||||
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