Reich 1987.
| Methods |
Parallel randomised controlled clinical trial Randomisation ratio: 1:1 Superiority design |
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| Participants |
Inclusion criteria: people with type 2 diabetes on insulin therapy Exclusion criteria: significant surgery within 3 months before entry into the study, major organ or system disease, medication use affecting glucose metabolism or sulphonylurea activity Diagnostic criteria: not stated |
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| Interventions |
Number of study centres: 2 Treatment before study: intervention: 36.5 (6.3) insulin, placebo: insulin 48.2 (4.0) U/day. Insulin regimen: only intermediate insulin Titration period: 12 days hospitalisation (after 6 weeks optimisation glycaemic control with insulin) |
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| Outcomes | Primary outcome(s) (as stated in the publication): serum and urinary glucoses, HbA1c, urinary C‐peptide, insulin dose, number of tablets prescribed, compliance | |
| Study details |
Total study duration: 5.5 months Run‐in period: 12 days Study terminated early (for benefit/because of adverse events): no |
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| Publication details |
Language of publication: English Funding source: Upjohn Publication status: peer‐reviewed journal |
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| Stated aim of study | Quote from publication: "To test the effect of combined glibenclamide‐insulin therapy over 4 months in 20 patients after achieving good control of fasting glucose with diet and intermediate insulin alone." | |
| Notes | Participants had adequate glycaemic control | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote from publication: "randomised" |
| Allocation concealment (selection bias) | Low risk | Quote from publication: "randomised by the hospital pharmacy" |
| Blinding of participants and personnel (performance bias) HbA1c, FPG, lipids | Low risk |
Quote from publication: (from abstract) "A placebo‐controlled, double‐blinded design..." Comment: Probably the participants and the personnel were blinded |
| Blinding of participants and personnel (performance bias) Insulin dose | Low risk |
Quote from publication: (from abstract) "A placebo‐controlled, double‐blinded design..." Comment: probably the participants and the personnel were 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) HbA1c, FPG, lipids | Unclear risk | Comment: not all outcome values were reported, only graphical |
| Incomplete outcome data (attrition bias) Insulin dose | Low risk | Comment: insulin dose was collected and reported |
| Selective reporting (reporting bias) | Unclear risk |
Comment: not all outcome values were reported, only graphical Comment: dropouts were described; intention‐to‐treat |
| Other bias | Unclear risk | Comment: funded by a pharmaceutical company |