Groop 1985.
| Methods |
Cross‐over randomised controlled clinical trial Randomisation ratio: 1:1 Superiority design |
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| Participants |
Inclusion criteria: onset of non‐ketotic diabetes after the age of 35 years, treated with oral antidiabetic drugs for at least 1 year before insulin therapy was started due to secondary drug failure. Exclusion criteria: not stated Diagnostic criteria: not stated |
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| Interventions |
Number of study centres: 1 Treatment before study: insulin 0.75 ± 0.11 IU/kg per day Titration period: none |
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| Outcomes | Primary outcome(s) (as stated in the publication): insulin dose and bodyweight, glycaemic control (HbA1c, FBG, blood glucose profile), serum insulin levels, C‐peptide, lipids | |
| Study details |
Total study duration: 24 weeks (2 x 8 = 16 weeks intervention) Run in period: 8 weeks 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 review journal |
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| Stated aim of study | Quote from publication: "To investigate the metabolic effects of the combination of insulin and sulphonylurea (glibenclamide) during controlled long‐term therapy in NIDDM patients whose hyperglycaemia could not be controlled by insulin alone." | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote from publication: "...the patients were randomly allocated to 8 weeks of treatment with ....." |
| 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 a double‐blind cross‐over study we compared the effect of...." 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 a double‐blind cross‐over study we compared the effect of...." Comment: probably the participants and the personnel were blinded |
| Blinding of participants and personnel (performance bias) Insulin dose | Low risk |
Quote from publication: "In a double‐blind cross‐over study we compared the effect of...." 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 of adverse events (myocardial infarct, weight gain) were collected and reported |
| Incomplete outcome data (attrition bias) HbA1c, FPG, lipids | Low risk | Comment: all outcome data were collected and reported |
| Incomplete outcome data (attrition bias) Insulin dose | Low risk | Comment: all data on insulin dose were collected and reported |
| Selective reporting (reporting bias) | Unclear risk | Comment: unclear graphical reporting of data |
| Other bias | Low risk | Comment: none |