Lewitt 1989.
| Methods |
Cross‐over randomised controlled clinical trial Randomisation ratio: 1:1 Superiority design |
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| Participants |
Inclusion criteria: insulin treated participants who were not ketosis prone and had previous primary or secondary oral hypoglycaemic failure. Exclusion criteria: combined insulin‐sulphonylurea therapy Diagnostic criteria: not stated |
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| Interventions |
Number of study centres: 1 Treatment before study: insulin 47.3 ± 21.3 U/day. Insulin regimen: once or twice daily Titration period: none |
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| Outcomes | Primary outcome(s) (as stated in the publication): glycaemic control (HbA1c, self‐monitored fasting and postprandial glucose), BMI, C‐peptide, insulin dosage | |
| Study details |
Total study duration: 6 months Run‐in period: none Study terminated early (for benefit/because of adverse events): no |
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| Publication details |
Language of publication: English Funding source: none Publication status: peer‐reviewed journal |
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| Stated aim of study | Quote from publication: "To determine which patient characteristics best predict a beneficial response to combined Insulin‐gliburide therapy." | |
| 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: "Glyburide was compared with placebo in a double‐blind crossover design" Comment: probably the participants and the personnel were blinded |
| Blinding of participants and personnel (performance bias) HbA1c, FPG, lipids | Low risk |
Quote from publication: "Glyburide was compared with placebo in a double‐blind crossover design" Comment: probably the participants and the personnel were blinded |
| Blinding of participants and personnel (performance bias) Insulin dose | Low risk |
Quote from publication: "Glyburide was compared with placebo in a double‐blind crossover design" 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 | Low risk | Comment: outcome data were collected and reported |
| Incomplete outcome data (attrition bias) Insulin dose | Low 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 | Low risk | Comment: none |