Z015 2007.
| Methods | Parallel randomised controlled clinical trial | |
| Participants |
Inclusion criteria: IDDM, aged 12‐70 years, insulin therapy for ≥ 2 months before study entry Exclusion criteria: any other severe disease, current use of insulin infusion devices, hypoglycaemia unawareness, > 2 hospital admissions due to hypoglycaemia in the previous year Diagnostic criteria: WHO 1980 |
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| Interventions |
Number of study centres: multicentre (number of centres not known) Treatment before study: human insulin therapy for ≥ 2 months before study Titration period: ‐ Insulin lispro vs. RHI (see Appendix 2) |
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| Outcomes |
Outcomes reported in abstract of publication: no abstract available Primary outcome(s): uncleara Secondary outcome(s): not defined Other outcome(s): HbA1c, hypoglycaemia (mild, severe, nocturnal), adverse events, quality of life |
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| Study details |
Run‐in period: 2‐4 weeks Study terminated before regular end: no |
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| Publication details |
Language of publication: English Funding: commercial (Eli Lilly) Publication status: full article in a peer‐reviewed journal (pooled analysis of Z011 2007, Z013 2007, and Z015 2007 in Garg 1996) |
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| Stated aim for study | Quote from publication: "The purpose of the present 1‐year prospective randomised clinical trial was to compare HumulinRb to the human insulin analogue lispro, with respect to postprandial glucose excursions, frequency of hypoglycaemic episodes, glucose control, body weight, body mass index (BMI), and safety in subjects with type 1 diabetes"c | |
| Notes | aStudy report described post‐prandial glucose values as primary endpoint, but used HbA1c, pre‐prandial blood sugar and hypoglycaemia for power analysis; study protocol mentioned several primary endpoints: post‐prandial blood sugar excursions, hypoglycaemia in relation to glycaemic control and metabolic control bRHI cFrom Garg 1996 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Comment: considered adequate in IQWIG 2007 based on information from original study reports |
| Allocation concealment (selection bias) | Low risk | Comment: considered adequate in IQWIG 2007 based on information from original study reports |
| 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: laboratory parameters assessed in central laboratory ‐ HbA1c assessment 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 | Comment: considered adequate in IQWIG 2007 based on information from original study reports |
| Incomplete outcome data (attrition bias) Subjective outcomes | Low risk | Comment: considered adequate in IQWIG 2007 based on information from original study reports |
| Selective reporting (reporting bias) | High risk | Comment: primary outcome unclear because of inconsistent information in publication, study report and study protocol |
| Other bias | Unclear risk | Comment: not enough information to judge |
"‐" denotes not reported.
BMI: body mass index; h: hour; HbA1c: glycosylated haemoglobin A1c; IDDM: insulin‐dependent diabetes mellitus; ITT: intention‐to‐treat; IU: international unit; RHI: regular human insulin; s.c.: subcutaneous; U: unit; WHO: World Health Organization.