VA‐CSDM Study 1992.

Methods	Study design: parallel RCT Study duration recruitment): to 1991 Follow‐up period: 27 months
Participants	Country: USA Setting: multicentre (5) Patients aged 40 to 69 years with newly diagnosed type 2 diabetes; being treated with insulin Number: treatment group (75); control group (78) Mean age ± SD (years): treatment group (60.4 ± 6.4); control group (59.9 ± 6.7) Sex (M/F): not reported Exclusion criteria: albuminuria > 0.5 g/24h; SCr > 141.4 μmol/L; clinically evident autonomic neuropathy; current or previous diabetic gangrene
Interventions	Treatment group Intensive treatment Control group Conventional treatment
Outcomes	Major cardiovascular events (including new myocardial infarction, congestive heart failure, stroke, amputation for ischaemic gangrene, and cardiovascular mortality) Angina or documented coronary disease, angioplasty or bypass graft, transitory ischaemic attacks, claudication, ischaemic ulcers
Notes	Funding source: Roerig/Pfizer
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Stratification was done separately for each participating hospital and by status of any known cardiovascular complications at entry
Allocation concealment (selection bias)	Low risk	Small balance intervals were used to ensure that an equal number of patients were randomised to each treatment group within each stratum
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Insufficient information to permit judgement
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Data on clinical outcomes were adjudicated by a central committee whose members were unaware of study group assignments
Incomplete outcome data (attrition bias) All outcomes	Low risk	4/153 lost to follow‐up (3%)
Selective reporting (reporting bias)	Low risk	All outcome data reported
Other bias	Low risk	Funded by Roerig/Pfizer