Table 3.
All randomised controlled trials comprising a premixed insulin analogue regimen in previously insulin-naïve patients with type 2 diabetes. Premixed analogue arm baseline demographic and treatment effects listed in rank order according to duration of diabetes. Age (mean±s.d.) or (median (quartiles)); duration of diabetes (mean±s.d.) or (median (quartiles)).
| Trial | Insulin treatment | OAD treatment | Study | HbA1c (%) | Hypoglycaemia | Weight | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ref. | Preparation | Regimen | OAD | Change from baseline | Duration (weeks) | Patients (n) | Male (%) | Diabetes duration (years) | Baseline | EOT | Episodes | Definition | Change (kg) |
| (90) | NM30 | QD | → | 13d | 129 | 48 | 4.4±1.4 | 8.6±1.2 | Not given | Not given | +1.0 | ||
| (28) | LM50 | TID | ↓ | 24d | 54 | 59 | 5.9±3.0 | 8.1±1.2 | 6.5 (7.1, 6.4)a | 5.5b,f | S/BG <54 mg/dl | +1.8±3.4 | |
| (26) | LM50×2+LM25 | TID | → | 16e | 60 | 57 | 8.4±4.9 | 9.2±1.3 | 7.1±0.1 | 10.8b,f | BG <54 mg/dl | +2.0±0.4 | |
| (51) | NM30 | BID | +Met | ↓ | 16d | 100 | 27 | 8.4±5.7 | 10.4±1.7 | 7.3±1.2 | 0.7f | BG <56 mg/dl | +1.5 |
| (21) | NM30 | BID | → | 52d | 235 | 68 | 9.0 (6.0, 12.0) | 8.6±0.8 | 7.3±0.9 | 5.7f | BG <56 mg/dl | +4.7±4.0 | |
| (23) | NM30 | QD | +Met+SU | 26d | 231 | 47 | 9.1±5.8 | 8.5±1.0 | 7.1 | 6.5f | S/BG <56 mg/dl | +1.7 | |
| (50) | NM30 | BID | −Met−TZD | ↓ | 34d | 102 | 46 | 9.2±6.2 | 8.1±1.0 | 6.5±1.0 | 8.3f | BG <56 mg/dl | +4.6±4.3 |
| (30) | NM30 | BID | +Met±TZD | ↓ | 28d | 117 | 53 | 9.5±5.9 | 9.7±1.5 | 6.9±1.2 | 3.4f | S/BG <56 mg/dl | +5.4±4.8 |
| (24) | LM25 | BID | → | 24d | 1045 | 53 | 9.7±6.3 | 9.1±1.3 | 7.2±1.1 | 28.0f | S/BG <70 mg/dl | +3.6±4.0 | |
| (51) | NM30 | BID>TID | −All | ↓ | 16d | 104 | 16 | 9.9±6.2 | 10.4±1.4 | 7.6±1.2 | 0.7f | BG <56 mg/dl | +1.7 |
| (25) | NM30 | BID | +Met | ↓ | 28d | 128 | 54 | 10.3±7.5 | 9.2±1.4 | 7.5±1.1 | 20.3g | BG <56 mg/dl | +0.7 |
| (18) | NM30 | QD | +Met | ↓ | 12d | 46 | 54 | 10.4±8.6 | 9.5±1.8 | 8.3a | 24.0g | S/BG <50 mg/dl | Not given |
| (48) | NM30 | BID | −SU | ↓ | 26d | 21 | 76 | 11.0 (5.0, 16.5)c | 9.3 (8.1, 11.3) | 7.4 (6.9, 8.7) | Not given | Not given | |
| (29) | LM25 | BID | +Met | ↓ | 16e | 105 | 63b | 9.0±6.6b | 8.7±1.3 | 7.4±1.1 | 8.4f | S/BG <63 mg/dl | +2.3±1.0 |
Ref., references; NM30, NovoMix 30; LM50, lispro mix 50; >, intensification; EOT, End of treatment; QD, once daily; BID, twice daily; Met, metformin; SU, sulphonylurea; TZD, thiazoledinedione; →, unchanged; ↓, reduced; BG, blood glucose; S/BG, Symptoms or BG.
Values obtained by digitising published figures.
Values obtained by calculations based on published data.
Duration of sulphonylurea use.
Parallel study design.
Crossover study design.
Incidence reported as events per patient year.
Prevalence reported as % with at least one event.