Mezitis 1992.
| Methods |
Parallel randomised controlled clinical trial Randomisation ratio: 1:1 Superiority design |
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| Participants |
HbA1c before randomisation (% (SD)): intervention 8.7, control 8.6 Inclusion criteria: people with type 2 diabetes with insulin therapy for ≥ 1 year. Exclusion criteria: endocrinologic disease other than diabetes mellitus, history of allergies to sulphonamides and/or insulin, history of impaired gastric emptying, active hepatic disease, renal disease significantly impairing creatinine clearance, current treatment with steroids, oestrogens, progestogens, beta‐blockers, Ca‐channel antagonists, diuretics, monoamine oxidase inhibitors, clonidine, probenecid, anticoagulants, NSAID Diagnostic criteria: not stated |
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| Interventions |
Number of study centres: 1 Treatment before study: insulin monotherapy, dosages not stated Titration period: yes, duration not stated |
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| Outcomes | Primary outcome(s) (as stated in the publication): urinary C‐peptide, HbA1c, lipids, insulin requirement, glycaemic profiles in response to test meals | |
| Study details |
Total study duration: 20 weeks Run‐in period: unclear Study terminated early (for benefit/because of adverse events): no |
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| Publication details |
Language of publication: English Funding source: UpJohn, Boehringer Mannheim, Becton Dickinson Publication status: peer‐reviewed journal |
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| Stated aim of study | Quote from publication: "To investigate the effects of addition of glibenclamide to the regimen of insulin‐treated non‐insulin‐dependent diabetes mellitus (NIDDM) patients with regard to their overall insulin requirements and dosage schedule and to assess persistence of these effects." | |
| Notes | A lot of data were missing: dose of glibenclamide, incomplete study design and baseline data | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote from publication: "random assignment to equal‐sized parallel‐groups" |
| 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) HbA1c, FPG, lipids | Low risk |
Quote from publication: "The study was double‐blinded with random assignment to equal‐sized parallel‐groups..." 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 double‐blinded with random assignment to equal‐sized parallel‐groups..." 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 | High risk | Comment: outcomes of C‐peptide, lipids and HbA1c assays were not reported |
| Incomplete outcome data (attrition bias) Insulin dose | High risk | Comment: missing data on dose of glibenclamide |
| Selective reporting (reporting bias) | High risk | Comment: outcomes of C‐peptide, lipids and HbA1c assays were not reported |
| Other bias | High risk | Comment: no data on adverse events and population size; funded by a pharmaceutical company |