Iwamoto 2001.
| Methods |
Parallel randomised controlled clinical trial Randomisation ratio: 2:1 |
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| Participants |
Inclusion criteria: diabetes duration > 2 years, insulin treatment > 1 year, capable of coping with hypoglycaemia, 1‐3 times insulin injection, blood glucose ‐ self monitoring, HbA1c < 11%, BMI < 30, aged > 12 years Exclusion criteria: ‐ Diagnostic criteria: ‐ |
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| Interventions |
Number of study centres: multicentre (number of centres not reported) Treatment before study: insulin treatment > 1 year Titration period: 168 days (24 weeks) Insulin aspart vs. RHI (see Appendix 2) |
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| Outcomes |
Outcomes reported in abstract of publication: change in HbA1c, blood glucose 90 minutes after breakfast, adverse events, insulin antibodies Primary outcome(s): Secondary outcome(s): Other outcome(s): |
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| Study details |
Run‐in period: 6 weeks Study terminated before regular end: no |
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| Publication details |
Language of publication: Japanese Funding: commercial (Novo Nordisk) Publication status: peer‐reviewed journal/full article |
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| Stated aim for study | Quote from publication: "The efficacy and safety of insulin aspart, a rapid‐acting insulin, were investigated in type 1 diabetes patients treated in basal‐bolus regimen compared to soluble human insulin" | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Comment: not described |
| Allocation concealment (selection bias) | Unclear risk | Comment: not described |
| Blinding of participants and personnel (performance bias) Objective outcomes | High risk | Comment: unblinded |
| Blinding of participants and personnel (performance bias) Subjective outcomes | High risk | Comment: unblinded |
| Blinding of outcome assessment (detection bias) Objective outcomes | Unclear risk | Comment: HbA1c measured at a central laboratory |
| Blinding of outcome assessment (detection bias) Subjective outcomes | Unclear risk | Comment: not known |
| Incomplete outcome data (attrition bias) Objective outcomes | High risk | Comment: number of drop‐outs reported, but no details; analysis seems to be complete case |
| Incomplete outcome data (attrition bias) Subjective outcomes | High risk | Comment: number of drop‐outs reported, but no details; analysis seems to be complete case |
| Selective reporting (reporting bias) | Unclear risk | Comment: not enough information to make judgement on selective reporting |
| Other bias | Unclear risk | Comment: not enough information on data analysis |