Yilmaz 2007.
| Methods |
Parallel randomised controlled clinical trial Randomisation ratio: 1:1:1 Superiority design |
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| Participants |
Inclusion criteria: people with poorly controlled type 2 diabetes on insulin monotherapy Exclusion criteria: severe hypertension, repeated hypoglycaemic episodes, severe cardiovascular and cerebrovascular disease, renal or hepatic failure, acute diabetic complications, incipient heart failure, pregnancy, breastfeeding Diagnostic criteria: not stated |
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| Interventions |
Number of study centres: 1 Treatment before study: insulin MIX 30/70 aspart/NPH Titration period: not stated |
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| Outcomes |
Primary outcome(s) (as stated in the publication): change in HbA1c Secondary outcomes (as stated in the publication): changes in insulin dosage, body weight, waist‐to‐hip ratio, lipids ADDITIONAL OUTCOMES: incidence of hypoglycaemia and side effects |
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| Study details |
Total study duration: 6 months 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: not stated Publication status: peer‐reviewed journal |
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| Stated aim of study | Quote from publication: "To investigate the glucose lowering effects of insulin alone, insulin plus metformin, insulin plus rosiglitazone, or insulin plus acarbose in subjects with type 2 diabetes mellitus and determine the type of treatment that would influence the serum level of total cholesterol, LDL‐C, HDL‐C, CRP and fibrinogen in these patients." | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote from publication: "After the initial assessment, subjects were randomly assigned to continue insulin therapy alone, or add acarbose (300 mg/day), or metformin (1,700 mg/day), or rosiglitazone (8 mg/day) to insulin therapy." |
| 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 | Unclear risk | Comment: unclear, not described |
| Blinding of participants and personnel (performance bias) HbA1c, FPG, lipids | Unclear risk | Comment: unclear, not described |
| Blinding of participants and personnel (performance bias) Insulin dose | Unclear risk | Comment: unclear, not described |
| Blinding of outcome assessment (detection bias) Adverse events | Unclear risk | Comment: unclear, not described |
| Blinding of outcome assessment (detection bias) HbA1c, FPG, lipids | Unclear risk | Comment: unclear, not described |
| Blinding of outcome assessment (detection bias) Insulin dose | Unclear risk | Comment: unclear, not described |
| Incomplete outcome data (attrition bias) Adverse events | Low 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 reported |
| Selective reporting (reporting bias) | Low risk | Comment: all outcomes of interest were reported |
| Other bias | Unclear risk | Comment: funding not disclosed; differences in baseline data between groups; people with heart failure excluded |
Note: where the judgement is 'Unclear' and the description is blank, the study did not report that particular outcome.
NPH: Neutral Protamine Hagedorn