Kyllastinen 1985.
| Methods |
Cross‐over randomised controlled clinical trial Randomisation ratio: 1:1 Superiority design |
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| Participants |
Inclusion criteria: elderly patients, type 2 diabetes inadequately controlled by insulin Exclusion criteria: surgical operation; lack of co‐operation Diagnostic criteria: not stated |
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| Interventions |
Number of study centres: 1 Treatment before study: insulin 58 ± 3 IU/day (n = 1 once daily, n = 8 twice daily) Titration period: none |
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| Outcomes | Primary outcome(s) (as stated in the publication): glycaemic control (HbA1c, FPG), daily insulin dose, C‐peptide, bodyweight, triglyceride, total cholesterol, HDL‐cholesterol, Na, K, creatinine, chloride | |
| Study details |
Total study duration: 4 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 whether glibenclamide could improve glycaemic control in patients not adequately controlled by insulin." | |
| 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: "A double blind, cross over trial was assigned ...after randomisation patients were given either glibenclamide or placebo....5 patients started with glibenclamide and 4 with placebo" Comment: probably the participants and personnel were blinded |
| Blinding of participants and personnel (performance bias) HbA1c, FPG, lipids | Low risk |
Quote from publication: "A double blind, cross over trial was assigned...after randomisation patients were given either glibenclamide or placebo....5 patients started with glibenclamide and 4 with placebo" Comment: probably the participants and 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 |
| Incomplete outcome data (attrition bias) Adverse events | Low risk | Comment: data on weight gain were collected and reported |
| Incomplete outcome data (attrition bias) HbA1c, FPG, lipids | Low risk | Comment: outcome data were collected and reported |
| Selective reporting (reporting bias) | Low risk | Comment: all outcomes of interest were reported |
| Other bias | High risk | Comment: only 9 participants included |