DIABHYCAR 2004

Methods	Country: France Setting/Design: Multicentre Time frame: 1995‐2001 Randomisation method: NS Blinding ‐ Participants: Yes ‐ Investigators: Yes ‐ Outcome assessors: No ‐ Data analysis: No Intention‐to‐treat: Yes Follow‐up period: 3‐6 months Loss to follow‐up: 0
Participants	Inclusion criteria Age: > 50 years DM: Type 2 AER: > 20 mg/L Ramipril group Number: 2443 Age: 65.2 (8.4) Sex (M/F): 1701/742 Placebo group Number: 2469 Age: 65.0 (8.3) Sex (M/F): 1731/738 Exclusion criteria SCr > 150 µmol/L Treatment with insulin, ACEi or AIIRA Documented CHF MI during the past 3 months UTI Previous intolerance to an ACEi
Interventions	Ramipril group 1.25 mg/d Placebo group Co‐interventions: No
Outcomes	Cardiovascular death CVE ESKD Doubling of creatinine Amputation beyond MTP joint Regression of micro‐ to normoalbuminuria, macro‐ to micro/normoalbuminuria Adverse events (cough, hypertension, vertigo, diarrhoea, headache)
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Low risk	A ‐ Adequate