Mauerhoff 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 with insulin therapy for ≥ 1 year. Exclusion criteria: abnormal renal and hepatic functions, C‐peptide > 0.2 pmol/mL Diagnostic criteria: not stated |
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| Interventions |
Number of study centres: 1 Treatment before study: intervention: insulin 0.50 (0.07) U/day/kg, control insulin 0.44 (0.05) U/day/kg Titration period: 3 weeks lead‐in |
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| Outcomes | Primary outcome(s) (as stated in the publication): plasma glucose and C‐peptide after standardised breakfast, HbA1c (no assessment for technical reasons), fasting cholesterol and triglyceride, hypoglycaemia, insulin requirements | |
| Study details |
Total study duration: 16 weeks Run‐in period: 3 weeks Study terminated early (for benefit/because of adverse events): no |
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| Publication details |
Language of publication: English Funding source: Hoechst Belgium Publication status: peer‐reviewed journal |
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| Stated aim of study | Quote from publication: "We have studied the effect of the combination of a sulphonylurea (Hb 420 or glibenclamide) with insulin in 22 type 2 diabetic patients, treated with insulin and with residual insulin secretion." | |
| Notes | Use of intervention medication Hb420 (galenic form of glibenclamide) | |
| 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: "The study was carried out double‐blind......" Comment: probably the participants and the personnel were blinded |
| Blinding of participants and personnel (performance bias) HbA1c, FPG, lipids | Low risk |
Quote from publication: "The study was carried out double‐blind......" Comment: probably the participants and the personnel were blinded |
| Blinding of participants and personnel (performance bias) Insulin dose | Low risk |
Quote from publication: "The study was carried out double‐blind......" 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 number of hypoglycaemia were collected and reported |
| Incomplete outcome data (attrition bias) HbA1c, FPG, lipids | Unclear risk | Comment: HbA1c analyses not performed for technical reasons |
| Incomplete outcome data (attrition bias) Insulin dose | Low risk | Comment: data on insulin dose were collected and reported |
| Selective reporting (reporting bias) | Unclear risk | Comment: HbA1c analyses not performed for technical reasons |
| Other bias | Unclear risk | Comment: funded by a pharmaceutical company |