Stenman 1988.
| Methods |
Cross‐over randomised controlled clinical trial Randomisation ratio: 1:1 Superiority design |
|
| Participants |
Inclusion criteria: people with type 2 diabetes failing on oral antidiabetic agents Exclusion criteria: hepatic, renal or pulmonary dysfunction; secondary diabetes Diagnostic criteria: not stated |
|
| Interventions |
Number of study centres: 1 Treatment before study: intervention: 34 (4) insulin, placebo: insulin 26 (3) U/day. Insulin regimen: once or twice daily intermediate or intermediate mixed with short‐acting insulin Titration period: 4 months (2 weeks in hospital) initiation insulin therapy |
|
| Outcomes | Primary outcome(s) (as stated in the publication): HbA1c, fasting glucose, urinary glucose, C‐peptide after glucagon, insulin dose, lipids, body weight, free insulin | |
| Study details |
Total study duration: 8 months: 4 months run‐in and 4 months intervention Run‐in period: 2 weeks Study terminated early (for benefit/because of adverse events): no |
|
| Publication details |
Language of publication: English Funding source: Sigrid Juselius Foundation, Finnish Medical Association, Signe and Ane Gyllenberg foundation Publication status: peer‐reviewed journal |
|
| Stated aim of study | Quote from publication: "To examine the effect of the addition of glibenclamide to insulin therapy on glycaemic control and beta cell function." | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote from publication: "...the patients were randomised to a double‐blind treatment with insulin in combination with glibenclamide or insulin and placebo for four months" |
| 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 patients were randomised to a four‐months double‐blind cross‐over treatment...." 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 patients were randomised to a four‐months double‐blind cross‐over treatment...." Comment: probably the participants and the personnel were blinded |
| Blinding of participants and personnel (performance bias) Insulin dose | Low risk |
Quote from publication: "....the patients were randomised to a four‐months double‐blind cross‐over treatment...." 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 and hypoglycaemia were collected and 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 collected and reported |
| Selective reporting (reporting bias) | Low risk | Comment: some data were only reported graphically |
| Other bias | Low risk | Comment: none |