Lindstrom 1999.
| Methods |
Cross‐over randomised controlled clinical trial Randomisation ratio: 1:1 Superiority design |
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| Participants |
Inclusion criteria: participants with type 2 diabetes with insulin monotherapy for 6‐36 months. Exclusion criteria: not stated Diagnostic criteria: not stated |
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| Interventions |
Number of study centres: unclear Treatment before study: insulin 54.5 ± 6.9 U/day (at the end of the run‐in period) Insulin regimen: four times daily, regular plus intermediate insulin Titration period: 4‐8 weeks |
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| Outcomes | Primary outcome(s) (as stated in the publication): glycaemic control (blood glucose, HbA1c), insulin dose, C‐peptide, lipoproteins, IGF‐1, SHBG, serum testosterone | |
| Study details |
Total study duration: 7‐8 months Run‐in period: 4‐8 weeks Study terminated early (for benefit/because of adverse events): no |
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| Publication details |
Language of publication: English Funding source: Swedish Medical Research Council, Swedish Diabetes Association, County Council of Östergötland, Novo Nordisk Insulin Fund Publication status: peer‐reviewed journal |
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| Stated aim of study | Quote from publication: "To study whether changes in endogenous insulin secretion at the same glycaemic control affect the plasma concentration of lipoproteins in patients with type 2 diabetes mellitus." | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Comment: not possible to judge whether the sequence generation was adequate |
| Allocation concealment (selection bias) | Unclear risk | Comment: not possible to judge whether the allocation to the intervention and control group was concealed |
| Blinding of participants and personnel (performance bias) Adverse events | Low risk |
Quote from publication: "...in this randomised double‐blind crossover study." Comment: probably the participants and the personnel were blinded |
| Blinding of participants and personnel (performance bias) HbA1c, FPG, lipids | Low risk |
Quote from publication: "...in this randomised double‐blind crossover study." Comment: probably the participants and the personnel were blinded |
| Blinding of participants and personnel (performance bias) Insulin dose | Low risk |
Quote from publication: "...in this randomised double‐blind crossover study." Comment: probably the participants and the personnel were blinded |
| Blinding of outcome assessment (detection bias) Adverse events | Unclear risk | Comment: unclear if the outcome assessor was blinded |
| Blinding of outcome assessment (detection bias) HbA1c, FPG, lipids | Unclear risk | Comment: unclear if the outcome assessor was blinded |
| Blinding of outcome assessment (detection bias) Insulin dose | Unclear risk | Comment: unclear if the outcome assessor was blinded |
| Incomplete outcome data (attrition bias) Adverse events | Low risk | Comment: data on weight gain were reported |
| Incomplete outcome data (attrition bias) HbA1c, FPG, lipids | Unclear risk | Comment: outcome data were collected and reported |
| Incomplete outcome data (attrition bias) Insulin dose | Unclear risk | Comment: data on insulin dose were collected and reported |
| Selective reporting (reporting bias) | Low risk | Comment: all outcomes of interest were reported |
| Other bias | Unclear risk | Comment: also funded by pharmaceutical company |