Erem 2014.
| Study characteristics | ||
| Methods | Study design: parallel RCT | |
| Participants |
Inclusion criteria: age between 30 to 70 years, FPG ≥ 140 mg/dL or HbA1c ≥ 8% or ((FPG between 126 mg/dL to 139 mg/dL or HbA1c between 7% to 8 %) and HOMA‐IR > 3) Exclusion criteria: T1DM, ketoacidosis, ketonuria, renal function impairment (serum creatinine > 1.4 mg/dL for women and > 1.5 mg/dL for men), liver disease, impairment liver function (AST or ALT ≥ 2 × the upper limit of the normal range)), NYHA Cardiac Status Class III or IV congestive heart failure, history of lactic acidosis, malignancy, chronic inflammatory diseases, acute malabsorption, chronic pancreatitis, familial polyposis coli, active infection, pregnancy, hoping to conceive, breastfeeding, chronic obstructive pulmonary disease, angina pectoris, myocardial infarction, documented cerebrovascular disease, stroke, peripheral vascular disease, rheumatic disease, substance abuse, allergy to SUs, biguanides or TZDs, thyroid disease, or corticosteroid treatment Diagnostic criteria: ADA 2010 |
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| Interventions |
Intervention(s): metformin Comparator(s): gliclazide, pioglitazone Duration of intervention: 12 months Duration of follow‐up: 12 months Run‐in period: none Number of study centres: 1 |
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| Outcomes | Reported outcome(s) in full text of publication: safety, anthropometric measures, glycaemic variables, lipid profile, endothelial function, haematological variables, inflammation markers, blood pressure | |
| Study details |
Trial identifier: not reported Trial terminated early: no |
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| Publication details |
Language of publication: English Funding: non‐commercial funding (University) Publication status: peer‐reviewed journal / full article |
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| Stated aim for study | Quote from publication: "The main objective of the present study was to evaluate and compare the effects of gliclazide‐MR, MET and PIO monotherapies on glycemic control and conventional/non‐conventional cardiovascular risk factors including fibrinolysis, inflammation and endothelial functions in patients with newly diagnosed T2DM" | |
| 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‐label..." Comment: investigator‐assessed outcome. 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‐label..." Comment: investigator‐assessed outcome. No blinding, however, outcome not judged to be influenced by a lack of blinding. |
| Blinding of participants and personnel (performance bias) non‐fatal myocardial infarction | Low risk |
Quote from publication: "... open‐label..." Comment: investigator‐assessed outcome. 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‐label..." Comment: investigator‐assessed outcome. No blinding, however, outcome not judged to be influenced by a lack of blinding. |
| Blinding of participants and personnel (performance bias) severe hypoglycaemia | Low risk |
Quote from publication: "... open‐label..." Comment: investigator‐assessed outcome. 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‐label..." Comment: investigator‐assessed outcome. 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‐label..." Comment: investigator‐assessed outcome. No blinding, however, outcome not judged to be influenced by a lack of blinding. |
| Blinding of outcome assessment (detection bias) non‐fatal myocardial infarction | Low risk |
Quote from publication: "... open‐label..." Comment: investigator‐assessed outcome. 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‐label..." Comment: investigator‐assessed outcome. No blinding, however, outcome not judged to be influenced by a lack of blinding. |
| Blinding of outcome assessment (detection bias) severe hypoglycaemia | Low risk |
Quote from publication: "... open‐label..." Comment: investigator‐assessed outcome. 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: "... 60 patients with T2DM were initially recruited. Total 57 patients completed the study" Comment: 95% of participants included in the analysis, low dropout rate (95% of participants completed the study) and balanced between arms, reasons for missing data not described, inappropriate exclusion of participants not finishing trial, it is assumed that mortality status has been investigated in death registers at the end of the study |
| Incomplete outcome data (attrition bias) cardiovascular mortality | Low risk |
Quote from publication: "... 60 patients with T2DM were initially recruited. Total 57 patients completed the study" Comment: 95% of participants included in the analysis, low dropout rate (95% of participants completed the study) and balanced between arms, reasons for missing data not described, inappropriate exclusion of participants not finishing trial, it is assumed that mortality status has been investigated in death registers at the end of the study |
| Incomplete outcome data (attrition bias) non‐fatal myocardial infarction | High risk |
Quote from publication: "... 60 patients with T2DM were initially recruited. Total 57 patients completed the study" Comment: 95% of participants included in the analysis, low dropout rate (95% of participants completed the study) and balanced between arms, reasons for missing data not described, inappropriate exclusion of participants not finishing trial, the proportion of missing outcomes compared with observed event risk enough to induce clinically relevant bias in intervention effect estimate |
| Incomplete outcome data (attrition bias) serious adverse events | High risk |
Quote from publication: "... 60 patients with T2DM were initially recruited. Total 57 patients completed the study" Comment: 95% of participants included in the analysis, low dropout rate (95% of participants completed the study) and balanced between arms, reasons for missing data not described, inappropriate exclusion of participants not finishing trial, the proportion of missing outcomes compared with observed event risk enough to induce clinically relevant bias in intervention effect estimate |
| Incomplete outcome data (attrition bias) severe hypoglycaemia | High risk |
Quote from publication: "... 60 patients with T2DM were initially recruited. Total 57 patients completed the study" Comment: 95% of participants included in the analysis, low dropout rate (95% of participants completed the study) and balanced between arms, reasons for missing data not described, inappropriate exclusion of participants not finishing trial, the proportion of missing outcomes compared with observed event risk enough to induce clinically relevant bias in intervention effect estimate |
| Selective reporting (reporting bias) | Unclear risk | Comment: study protocol not available |
| Other bias | Low risk |
Quote from publication: "This study was supported by a research grant from the Karadeniz Technical University... We, the authors, have nothing to declare regarding the study drugs and producing companies... The authors declare that there is no conflict of interest that would prejudice the impartiality of this scientific work" Comment: low risk of funding bias |