Krawczyk 2005.
| Methods |
Parallel randomised controlled clinical trial Randomisation ratio: 1:1 Superiority design |
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| Participants |
Inclusion criteria: type 2 diabetes patients, diabetes duration of at least 5 years, BMI > 30, Insulin > 40 IU/day Exclusion criteria: contraindication for metformin, body weight change > 5 kg last year Diagnostic criteria: age > 35 years at diagnosis and at least 1 year of effective treatment with oral glucose‐lowering agents |
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| Interventions |
Number of study centres: 1 Treatment before study: insulin 2dd, 59.5 (15.4) IU/day intervention, 55.6 (16.3) IU/day control Titration period: none |
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| Outcomes | Primary outcome(s) (as stated in the publication): glycaemic control (HbA1c, glucose), bodyweight, insulin dose, WHR | |
| Study details |
Total study duration: 6 months Run‐in period: none Study terminated early (for benefit/because of adverse events): no |
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| Publication details |
Language of publication: Polish Funding source: not reported Publication status: unknown |
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| Stated aim of study | Quote from publication: "To assess the influence of adding metformin to insulin monotherapy on metabolic control in type 2 diabetes patients." | |
| Notes | Statistical methods not described | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Comment: randomisations in two groups of 20 participants |
| Allocation concealment (selection bias) | Unclear risk | Comment: randomisations in blocks of 4 (20 participants per group) |
| Blinding of participants and personnel (performance bias) Adverse events | Unclear risk | Comment: it is unclear if the study was blinded |
| Blinding of participants and personnel (performance bias) HbA1c, FPG, lipids | Unclear risk | Comment: it is unclear if the study was blinded |
| Blinding of participants and personnel (performance bias) Insulin dose | Unclear risk | Comment: it is unclear if the study was blinded |
| Blinding of outcome assessment (detection bias) Adverse events | Unclear risk | Comment: it is unclear if the study was blinded |
| Blinding of outcome assessment (detection bias) HbA1c, FPG, lipids | Unclear risk | Comment: it is unclear if the study was blinded |
| Blinding of outcome assessment (detection bias) Insulin dose | Unclear risk | Comment: it is unclear if the study was blinded |
| Incomplete outcome data (attrition bias) Adverse events | Low risk | Comment: weight gain was reported |
| Incomplete outcome data (attrition bias) HbA1c, FPG, lipids | Unclear 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: statistical methods were not described |