Fritsche 2000.
| Methods |
Cross‐over randomised controlled clinical trial Randomisation ratio: 1:1 Superiority design |
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| Participants |
Inclusion criteria: not clearly defined: severe obesity, moderate glycaemic control, intensive insulin therapy with regular specialist consultations for regimen adaptation for at least 6 months prior to inclusion Exclusion criteria: not stated Diagnostic criteria: not stated |
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| Interventions |
Number of study centres: 1 Treatment before study: intervention: insulin: NPH 26 ± 6 U/day and regular 27 ± 5 U/day control: insulin: NPH 20 ± 4 U/day and regular 26 ± 4 U/day Titration period: 6 weeks |
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| Outcomes | Primary outcome(s) (as stated in the publication): glycaemic control (HbA1c, blood glucose levels, OGTT), insulin dose, lipids, C‐peptide, lactate | |
| Study details |
Total study duration: 24 weeks Run‐in period: 6 weeks Study terminated early (for benefit/because of adverse events): no |
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| Publication details |
Language of publication: English Funding source: Lipha Pharmaceuticals (medication) Publication status: peer‐reviewed journal |
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| Stated aim of study | Quote from publication: "To examine the effect of adjunct metformin in 13 severely obese type 2 diabetes patients in sub optimal glucaemic control pretreated with intensified insulin therapy" on glycaemic control, insulin dosage, lipid profile and bodyweight | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote from publication: "Patients were randomly assigned to either metformin or placebo treatment (double‐blind)...." |
| 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) HbA1c, FPG, lipids | Low risk |
Quote from publication: "patients were randomised in a double‐blind fashion..." Comment: probably the participants and the personnel were blinded |
| Blinding of participants and personnel (performance bias) Insulin dose | Low risk |
Quote from publication: "patients were randomised in a double‐blind fashion..." Comment: probably the participants and the personnel were 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) HbA1c, FPG, lipids | Low risk | Comment: all outcome data were collected and reported |
| Incomplete outcome data (attrition bias) Insulin dose | Low risk | Comment: all outcome data were collected and reported |
| Selective reporting (reporting bias) | Low risk | Comment: all outcomes of interest were reported |
| Other bias | Unclear risk | Comment: funding by a pharmaceutical company |