Mudaliar 2010.
| Methods |
Parallel randomised controlled clinical trial Randomisation ratio: 1:1 Superiority design |
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| Participants |
Inclusion criteria: obese people with type 2 diabetes on insulin therapy alone and with HbA1c between 7.5% and 10%. Exclusion criteria: history of peripheral oedema, cardiac, hepatic or renal problems, or had been treated with NSAIDs or diuretics within 21 days of screening Diagnostic criteria: not stated |
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| Interventions |
Number of study centres: 1 Treatment before study: insulin monotherapy (IU/day (SD)): intervention: 105 (22), control 114 (11) Titration period: 4 weeks: weight maintenance, carbohydrate diet |
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| Outcomes | Primary outcome(s) (as stated in the publication): HbA1c, fasting plasma glucose, insulin dose, weight, total body water, extracellular fluid, renal measures, hormonal measures | |
| Study details |
Total study duration: 16‐20 weeks 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: Takeda pharmaceuticals, Veterans Medical Research Foundation, Department of Veterans Affairs and the VA San Diego Healthcare System, University of California San Diego Clin Res. Centre NIH Grant Publication status: peer‐reviewed journal |
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| Stated aim of study | Quote from publication: "To evaluate the effects of intensive insulin therapy alone or with added pioglitazone on renal salt/water balance and body fluid compartment shifts in type 2 diabetes." | |
| Notes | Funded by pharmaceutical company | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk |
Quote from publication: "After the completion of the baseline studies, subjects were randomised (in a double‐blind manner) to..." Comment: not possible to judge whether the sequence generation was adequate |
| 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 | Low risk |
Quote from publication: "After the completion of the baseline studies, subjects were randomised (in a double‐blind manner) to..." Comment: probably the participants and the personnel were blinded |
| Blinding of participants and personnel (performance bias) HbA1c, FPG, lipids | Low risk |
Quote from publication: "After the completion of the baseline studies, subjects were randomised (in a double‐blind manner) to..." Comment: probably the participants and the personnel were blinded |
| Blinding of participants and personnel (performance bias) Insulin dose | Low risk |
Quote from publication: "After the completion of the baseline studies, subjects were randomised (in a double‐blind manner) to..." 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 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: funding by pharmaceutical company; performed in clinical research centre |