Quatraro 1986.
| 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: not stated Diagnostic criteria: not stated |
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| Interventions |
Number of study centres: 1 Treatment before study: intervention: insulin 90 (6) U/day, control insulin 88 (5) U/day Insulin regimen: twice or thrice daily, porcine lente and/or rapid‐acting insulin Titration period: 2 months + 1‐2 weeks inpatient period |
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| Outcomes | Primary outcome(s) (as stated in the publication): diurnal glucose profile, HbA1c, C‐peptide, glucagon stimulated C‐peptide, insulin dose, weight | |
| Study details |
Total study duration: 14 months Run‐in period: 2 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‐reviewed journal |
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| Stated aim of study | Quote from publication: "We studied the influence of chronic sulphonylurea treatment on glucose metabolism and beta‐cell secretory activity in diabetic patients requiring insulin after secondary failure to oral drugs." | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote from publication: "They were allocated at random into two groups, each consisting of 15 subjects..." |
| 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 | Unclear risk | Comment: unclear if the study was blinded |
| Blinding of participants and personnel (performance bias) HbA1c, FPG, lipids | Unclear risk | Comment: unclear if the study was blinded |
| Blinding of participants and personnel (performance bias) Insulin dose | Unclear risk | Comment: unclear if the study was blinded |
| Blinding of outcome assessment (detection bias) Adverse events | Unclear risk | Comment: unclear if the study was blinded |
| Blinding of outcome assessment (detection bias) HbA1c, FPG, lipids | Unclear risk | Comment: unclear if the study was blinded |
| Blinding of outcome assessment (detection bias) Insulin dose | Unclear risk | Comment: unclear if the study was blinded |
| Incomplete outcome data (attrition bias) Adverse events | Low risk | Quote from publication: "weight remained stable throughout the study period." |
| 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 | High risk | Comment: different participant groups reported in figure and table |