Derosa 2003.

Study characteristics
Methods	Study design: parallel RCT
Participants	Inclusion criteria: T2DM, duration > 6 months, no previous oral glucose‐lowering drugs, LDL‐C > 2.59 mmol/L, HbA1c > 7.0% Exclusion criteria: hypertension, coronary heart disease, smoking, abnormal renal function, taking drugs likely to interact with repaglinide or metformin or affect glycaemic control Diagnostic criteria: not reported
Interventions	Intervention(s): metformin Comparator(s): repaglinide Duration of intervention: 14 months1 Duration of follow‐up: 14 months Run‐in period: 4 weeks placebo washout period to eliminate metabolic effects of previous non‐hypoglycaemic drug therapies Number of study centres: 1
Outcomes	Reported outcome(s) in full text of publication: safety, anthropometric measures, glycaemic variables, lipid profile, endothelial function, haematological variables
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: "The aim of the present study was to compare glycaemic control and cardiovascular risk factors in type 2 diabetic patients who had not previously taken oral hypoglycaemic agent during monotherapy with either repaglinide or metformin."
Notes	18‐week titration period followed by 12 months treatment
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote from publication: "... patients were randomly allocated..." Comment: method of random sequence generation inadequately described
Allocation concealment (selection bias)	Unclear risk	Quote from publication: "... patients were randomly allocated..." Comment: method of allocation concealment inadequately described
Blinding of participants and personnel (performance bias) serious adverse events	Low risk	Quote from publication: "... open‐label..." 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) severe hypoglycaemia	Low risk	Quote from publication: "... open‐label..." 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‐label..." 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) severe hypoglycaemia	Low risk	Quote from publication: "... open‐label..." Comment: investigator‐assessed outcome measurement. No blinding, however, outcome not judged to be influenced by a lack of blinding
Incomplete outcome data (attrition bias) serious adverse events	High risk	Comment: 100% of participants included in the analysis, moderate to high dropout rate (87.5% to 94.6% of participants completed the study) and not balanced between arms, reasons for missing data not similar between arms, unclear how missing data were handled, 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	Comment: 100% of participants included in the analysis, moderate to high dropout rate (87.5% to 94.6% of participants completed the study) and not balanced between arms, reasons for missing data not similar between arms, unclear how missing data were handled, the proportion of missing outcomes compared with observed event risk enough to induce clinically relevant bias in intervention effect estimate
Selective reporting (reporting bias)	High risk	Comment: study protocol not available. Clear that all‐cause mortality was measured but was not necessarily analysed; judgement says likely to have been analysed but not reported because of non‐significant results. Anthropometric measures and glycaemic control (HbA1c) reported in an inadequate format that could not be used in our meta‐analysis, because the results of the study consisted of multiple errors
Other bias	Unclear risk	Comment: funding source not reported