Relimpio 1998.
| Methods |
Parallel open‐label randomised controlled clinical trial Randomisation ratio: 1:1 Superiority design |
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| Participants |
Inclusion criteria: poorly controlled (HbA1c > 8%) people with type 2 diabetes on insulin therapy (≥ 0.5 IU/kg body weight in 2 or more daily doses)) Exclusion criteria: life‐threatening condition, contraindication for biguanides, serum creatinine < 132.6 μmol/L Diagnostic criteria: not stated |
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| Interventions |
Number of study centres: 1 Treatment before study: intervention: 47.9 (10) insulin, control: insulin 51.8 (9.6) U/day. Insulin regimen: twice or more daily, premixed soluble and NPH insulin or NPH insulin alone Titration period: 4 weeks increase metformin dose (1,275 g ‐> 2,550 g) |
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| Outcomes | Primary outcome(s) (as stated in the publication): HbA1c, glucose, lipids, blood pressure, height, weight, BMI, insulin dose, serum creatinine, albumin excretion rate, uric acid, compliance | |
| Study details |
Total study duration: 4 months 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: Novo Nordisk Publication status: peer‐reviewed journal |
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| Stated aim of study | Quote from publication: "To compare the effect of adding metformin to insulin therapy with a moderate increase in insulin dose alone in insulin‐treated, poorly controlled type 2 diabetes." | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote from publication: "... and were subsequently randomised (31 to insulin + metformin and 29 to insulin dose increase)" |
| Allocation concealment (selection bias) | Unclear risk | "patients were randomised into two study groups following an experimental design of open‐label randomisation." |
| Blinding of participants and personnel (performance bias) Adverse events | High risk | Quote from publication: "open‐label randomisation" |
| Blinding of participants and personnel (performance bias) HbA1c, FPG, lipids | High risk | Quote from publication: "open‐label randomisation" |
| Blinding of participants and personnel (performance bias) Insulin dose | High risk | Quote from publication: "open‐label randomisation" |
| Blinding of outcome assessment (detection bias) Adverse events | High risk | Quote from publication: "open‐label randomisation" |
| Blinding of outcome assessment (detection bias) HbA1c, FPG, lipids | High risk | Quote from publication: "open‐label randomisation" |
| Blinding of outcome assessment (detection bias) Insulin dose | High risk | Quote from publication: "open‐label randomisation" |
| Incomplete outcome data (attrition bias) Adverse events | Unclear risk | Comment: data on weight gain 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: all outcomes of interest were reported |
| Other bias | Unclear risk | Comment: funded by a pharmaceutical company |