Osei 1984.
| 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 serum glucose levels > 200 mg/dL and daily insulin requirement > 30 IU Exclusion criteria: renal and hepatic disease, allergies to sulphonylurea Diagnostic criteria: NDDG |
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| Interventions |
Number of study centres: 1 Control (route, total dose/day, frequency): placebo, oral Treatment before study: intervention: insulin 60.3 (7.1) U/day, control insulin 50.27 (5.0) U/day (insulin regimen: once or twice daily, short‐acting and/or intermediate insulin) Titration period: 4 weeks |
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| Outcomes | Primary outcome(s) (as stated in the publication): fasting glucose, HbA1c and C‐peptide, after OGTT serum glucose and C‐peptide, lipids, lipoproteins, weight, dietary intake, compliance | |
| Study details |
Total study duration: 16 weeks Run‐in period: 4 weeks Study terminated early (for benefit/because of adverse events): no |
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| Publication details |
Language of publication: English Funding source: UpJohn, Core Laboratory, Central Ohio Diabetes Association Publication status: peer‐reviewed journal |
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| Stated aim of study | Quote from publication: "To evaluate, in a double‐blind, placebo‐controlled manner, glucose and lipoprotein responses after long‐term use of combination therapy in the management of insulin‐treated patients with poorly controlled type 2 diabetes mellitus." | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote from publication: "Patients were randomly assigned in a double‐blind manner to receive either glyburide or placebo..." |
| 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: "Patients were randomly assigned in a double‐blind manner..." Comment: probably the participants and the personnel were blinded |
| Blinding of participants and personnel (performance bias) HbA1c, FPG, lipids | Low risk |
Quote from publication: "Patients were randomly assigned in a double‐blind manner..." Comment: probably the participants and the personnel were blinded |
| Blinding of participants and personnel (performance bias) Insulin dose | Low risk |
Quote from publication: "Patients were randomly assigned in a double‐blind manner..." 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 weight gain were reported |
| 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 reported |
| Selective reporting (reporting bias) | Low risk | Comment: all outcomes of interest were reported |
| Other bias | Unclear risk | Comment: funded by a pharmaceutical company |