Mattoo 2005.
| Methods |
Parallel randomised controlled clinical trial Randomisation ratio: 1:1 Superiority design |
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| Participants |
Inclusion criteria: people with type 2 diabetes with insulin therapy with or without oral antihyperglycaemic agents for ≥ 3 months, HbA1c ≥ 7,5% and ≥ 30 years at the time of diagnosis Exclusion criteria: type 1 DM, signs or symptoms of any chronic condition or drug or alcohol abuse, previous TZD, glucocorticoid, nicotinic acid or therapy for a malignancy (except basal cell or squamous cell cancer), breastfeeding, pregnancy, women of childbearing potential Diagnostic criteria: WHO |
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| Interventions |
Number of study centres: 39 Treatment before study: intervention: insulin 0.96 (0.03) U/day/kg, control insulin 0.92 (0.03) U/day/kg. Insulin regimen: once, twice, thrice or four times a day. Titration period: 2 weeks lead‐in (at the end oral agents were stopped) and 3 months insulin intensification period |
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| Outcomes | Primary outcome(s) (as stated in the publication): glycaemic control (HbA1c, fasting blood glucose), lipids, hs‐CRP, PAI‐1, hypoglycaemia, bodyweight, insulin dose | |
| Study details |
Total study duration: 6 months Run‐in period: 2 weeks Study terminated early (for benefit/because of adverse events): no |
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| Publication details |
Language of publication: English Funding source: Eli Lilly, Takeda Europe Publication status: peer‐reviewed journal |
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| Stated aim of study | Quote from publication: "To determine the effect of pioglitazone 30 mg plus insulin versus placebo plus insulin on glycaemic control, the serum lipid profile, and selected cardiovascular risk factors in patients with type 2 diabetes mellitus whose disease was inadequately controlled with insulin therapy alone despite efforts to intensify such treatment." | |
| Notes | Some participants also used oral antihyperglycaemic agents before study. Users and non‐users were separated in the analysis | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote from publication: "randomised" |
| Allocation concealment (selection bias) | Low risk | Quote from publication: "randomised with equal probability.... according to a central randomisation table generated by the study sponsor and administered by an automated interactive voice response system at all sites" |
| Blinding of participants and personnel (performance bias) Adverse events | Low risk |
Quote from publication: "this 6‐month, randomised, double blind, prospective, multicenter, placebo‐controlled, parallel‐group study was ...." Comment: probably the participants and the personnel were blinded |
| Blinding of participants and personnel (performance bias) HbA1c, FPG, lipids | Low risk |
Quote from publication: "this 6‐month, randomised, double blind, prospective, multicenter, placebo‐controlled, parallel‐group study was ...." Comment: probably the participants and the personnel were blinded |
| Blinding of participants and personnel (performance bias) Insulin dose | Low risk |
Quote from publication: "this 6‐month, randomised, double blind, prospective, multicenter, placebo‐controlled, parallel‐group study was ...." 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 adverse events and 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 pharmaceutical companies |