Kiyici 2009.
| Study characteristics | ||
| Methods | Study design: parallel RCT | |
| Participants |
Inclusion criteria: T2DM, age between 30 to 65 years, HbA1c < 8% and BMI < 40 kg/m2 Exclusion criteria: use of hypoglycaemic agents, cardiovascular, gastrointestinal, hepatic, renal, rheumatological, neoplastic, infectious and other endocrine diseases (except T2DM and hyperlipidaemia), micro‐ and macrovascular complications of T2DM, smoker, previous history of substance abuse Diagnostic criteria: ADA 2006 |
|
| Interventions |
Intervention(s): metformin Comparator(s): rosiglitazone, no intervention Duration of intervention: 52 weeks Duration of follow‐up: 52 weeks Run‐in period: none Number of study centres: 1 |
|
| Outcomes | Reported outcome(s) in full text of publication: safety, glycaemic variables, anthropometric measures, lipid profile, arterial stiffness | |
| Study details |
Trial identifier: not reported Trial terminated early: no |
|
| Publication details |
Language of publication: English Funding: not reported Publication status: peer‐reviewed journal/full article |
|
| Stated aim for study | Quote from publication: "...to investigate the long‐term effects of metformin and rosiglitazone monotherapy with medical nutrition treatment (MNT) and of MNT alone on SAEI, LAEI, and serum MCP‐1 and MMP‐9 levels in drug‐naive type 2 diabetic patients" | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk |
Quote from publication: "... patients were randomized..." Comment: method of random sequence generation inadequately described |
| Allocation concealment (selection bias) | Unclear risk |
Quote from publication: "... patients were randomized..." Comment: method of allocation concealment inadequately described |
| Blinding of participants and personnel (performance bias) all‐cause mortality | Low risk |
Quote from publication: "... open‐labeled..." Comment: investigator‐assessed outcome measurement. No blinding, however, outcome not judged to be influenced by a lack of blinding |
| Blinding of participants and personnel (performance bias) cardiovascular mortality | Low risk |
Quote from publication: "... open‐labeled..." Comment: investigator‐assessed outcome measurement. No blinding, however, outcome not judged to be influenced by a lack of blinding |
| Blinding of participants and personnel (performance bias) serious adverse events | Low risk |
Quote from publication: "... open‐labeled..." Comment: investigator‐assessed outcome measurement. No blinding, however, outcome not judged to be influenced by a lack of blinding |
| Blinding of outcome assessment (detection bias) all‐cause mortality | Low risk |
Quote from publication: "... open‐labeled..." Comment: investigator‐assessed outcome measurement. No blinding, however, outcome not judged to be influenced by a lack of blinding |
| Blinding of outcome assessment (detection bias) cardiovascular mortality | Low risk |
Quote from publication: "... open‐labeled..." Comment: investigator‐assessed outcome measurement. No blinding, however, outcome not judged to be influenced by a lack of blinding |
| Blinding of outcome assessment (detection bias) serious adverse events | Low risk |
Quote from publication: "... open‐labeled..." Comment: investigator‐assessed outcome measurement. No blinding, however, outcome not judged to be influenced by a lack of blinding |
| Incomplete outcome data (attrition bias) all‐cause mortality | Low risk |
Quote from publication: "All patients completed the study" Comment: 100% of participants included in the analysis, all participants completed the study |
| Incomplete outcome data (attrition bias) cardiovascular mortality | Low risk |
Quote from publication: "All patients completed the study" Comment: 100% of participants included in the analysis, all participants completed the study |
| Incomplete outcome data (attrition bias) serious adverse events | Low risk |
Quote from publication: "All patients completed the study. No serious adverse effect was seen during the study period" Comment: 100% of participants included in the analysis, all participants completed the study |
| Selective reporting (reporting bias) | High risk | Comment: study protocol not available |
| Other bias | Unclear risk | Comment: funding source not reported |