Raskin 2000.
| Methods |
Parallel randomised controlled clinical trial Randomisation ratio: 2:1 |
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| Participants |
Inclusion criteria: aged 18‐75 yearsa, type 1 diabetes for ≥ 18 monthsb, BMI ≤ 35.0 kg/m2, HbA1c ≤ 11% Exclusion criteria: impaired hepatic, renal, or cardiac function; recurrent major hypoglycaemia; active proliferative retinopathy; total daily insulin dose ≥ 1.4 IU/kg; women were excluded if they were pregnant, breastfeeding or not practicing contraception Diagnostic criteria: WHO 1994 |
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| Interventions |
Number of study centres: 59 (in the US and Canada) Treatment before study: ≥ 1 year of therapy Titration period: 6 monthsc Insulin aspart vs. RHI (see Appendix 2) |
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| Outcomes |
Outcomes reported in abstract of publication: 8‐point blood glucose profiles, HbA1c, adverse events, overall hypoglycaemic episodes Primary outcome(s): HbA1c Secondary outcome(s): not specified Other outcome(s): hypoglycaemia (mild, severe, nocturnald), adverse events |
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| Study details |
Run‐in period: 4‐ to 5‐week run‐in period Study terminated before regular end: no |
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| Publication details |
Language of publication: English Funding: commercial (Novo Nordisk) Publication status: full article in a peer‐reviewed journal |
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| Stated aim for study | Quote from publication: "To compare long‐term glycaemic control and safety of using insulin aspart (IAsp) with that of regular human insulin (HI)" | |
| Notes | aAccording to study report ≥ 18 years bAccording to study report ≥ 24 months cParticipants were treated with insulin aspart or RHI for 6 months, but could continue their assigned treatment in a 6‐month extension of the study dNot defined as an outcome in the methods section of the study report | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "After the run‐in period, subjects were randomised, in a 2:1 ratio, to receive either IAsp [insulin aspart] or HI [RHI] as their mealtime insulin" Comment: no details |
| Allocation concealment (selection bias) | Unclear risk | Comment: not reported |
| Blinding of participants and personnel (performance bias) Objective outcomes | High risk | Quote: "open‐label" Comment: no blinding |
| Blinding of participants and personnel (performance bias) Subjective outcomes | High risk | Quote: "open‐label" Comment: no blinding |
| Blinding of outcome assessment (detection bias) Objective outcomes | Unclear risk | Comment: HbA1c analysed in central laboratory, therefore likely to be blinded |
| Blinding of outcome assessment (detection bias) Subjective outcomes | Unclear risk | Comment: not described |
| Incomplete outcome data (attrition bias) Objective outcomes | Low risk | Quote: "The last observation carried forward approach was used for missing data in most analyses" Comment: for blood glucose profiles values before and after all 3 meals were required for inclusion in the analysis |
| Incomplete outcome data (attrition bias) Subjective outcomes | Low risk | Quote: "The last observation carried forward approach was used for missing data in most analyses" Comment: for blood glucose profiles values before and after all 3 meals were required for inclusion in the analysis |
| Selective reporting (reporting bias) | Unclear risk | Comment: inconsistently reported data between different publications (also see IQWIG 2007), weight gain results reported after 12 months, but not after 6 months |
| Other bias | High risk | Comment: inconsistencies regarding the data in different publications (also see IQWIG 2007), number of drop‐outs reported, but reasons not clearly stated |