Giugliano 1993.
| Methods |
Parallel randomised controlled clinical trial Randomisation ratio: 1:1 Superiority design |
|
| Participants |
Inclusion criteria: age at diagnosis > 40 years, duration of disease > 3 years, duration of previous response to oral drugs > 1 year, inadequate metabolic control even when on maximal doses of sulphonylurea Exclusion criteria: age > 70 years, creatinine > 1.2 mg/dL, ischaemic of wasting disease, acute severe diseases Diagnostic criteria: not stated |
|
| Interventions |
Number of study centres: 1? Treatment before study: intervention: insulin: lente + regular 2 dd 90 ± 9 U/day; control: insulin lente + regular 2 dd 88 ± 9.4 U/day Titration period: 4 weeks |
|
| Outcomes | Primary outcome(s) (as stated in the publication): glycaemic control (HbA1c, daily glucose levels), lipids, blood pressure, body weight, insulin dose, beta‐cell function (C‐peptide, insulin) | |
| Study details |
Total study duration: 7 months Run‐in period: 4 weeks Study terminated early (for benefit/because of adverse events): no |
|
| Publication details |
Language of publication: English Funding source: not reported Publication status: peer‐reviewed journal |
|
| Stated aim of study | Quote from publication: "To evaluate the effectiveness and safety of metformin in obese type 2 diabetic patients poorly controlled by conventional insulin therapy." | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote from publication: "Phase II (double‐blind) patients were randomly assigned to continue to receive placebo or to treatment with metformin for six months" |
| 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: "Phase II (double‐blind) patients were randomly assigned to continue to receive placebo or to treatment with metformin for six months Comment: probably the participants and the personnel were blinded |
| Blinding of participants and personnel (performance bias) Insulin dose | Low risk |
Quote from publication: "Phase II (double‐blind) patients were randomly assigned to continue to receive placebo or to treatment with metformin fro six months" 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: data on insulin dose were collected and reported |
| Selective reporting (reporting bias) | Low risk | Comment: no |
| Other bias | Low risk | Comment: no |