Strowig 2002.
| Methods |
Parallel randomised controlled clinical trial Randomisation ratio: 1:1:1 Superiority design |
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| Participants |
Inclusion criteria: people with type 2 diabetes on insulin therapy (≥ 30 IU/day), 24‐70 years, HbA1c ≥ 7.0%, normal renal and hepatic function Exclusion criteria: not stated Diagnostic criteria: not stated |
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| Interventions |
Number of study centres: 1 Treatment before study: metformin insulin 82.9 U/day, troglitazone insulin 96.5 U/day, control insulin 80.3 U/day. Insulin regimen: 2 or more daily, 70/30 mix insulin or intermediate and short‐acting insulin Titration period: 4 weeks |
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| Outcomes | Primary outcome(s) (as stated in the publication): insulin dose, lipids, HbA1c, glucose, C‐peptide, body weight, Alat, Asat, medical history, physical exam, waist‐hip measurement, 3‐day food record, serum chemistry | |
| Study details |
Total study duration: 4 weeks run‐in and 12 weeks intervention 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: Bristol Myers Squibb Publication status: peer‐reviewed journal |
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| Stated aim of study | Quote from publication: "To evaluate the safety and efficacy of treatment with insulin alone, insulin plus metformin, or insulin plus troglitazone for 4 months in type 2 DM." | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote from publication: "Subjects ... were randomly assigned ..." |
| Allocation concealment (selection bias) | Low risk | Quote from publication: "Random assignment was determined by the sponsor who provided sealed sequentially numbered envelopes" |
| Blinding of participants and personnel (performance bias) Adverse events | High risk | Quote from publication: "...were randomly assigned in an unmasked fashion..." |
| Blinding of participants and personnel (performance bias) HbA1c, FPG, lipids | High risk | Quote from publication: "...were randomly assigned in an unmasked fashion..." |
| Blinding of participants and personnel (performance bias) Insulin dose | High risk | Quote from publication: "...were randomly assigned in an unmasked fashion..." |
| Blinding of outcome assessment (detection bias) Adverse events | High risk | Quote from publication: "...were randomly assigned in an unmasked fashion..." |
| Blinding of outcome assessment (detection bias) HbA1c, FPG, lipids | High risk | Quote from publication: "...were randomly assigned in an unmasked fashion..." |
| Blinding of outcome assessment (detection bias) Insulin dose | High risk | Quote from publication: "...were randomly assigned in an unmasked fashion..." |
| Incomplete outcome data (attrition bias) Adverse events | Low risk | Comment: data on adverse events 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) | Unclear risk | Comment: medical history and physical exam were not reported |
| Other bias | Unclear risk | Comment: funded by a pharmaceutical company |