IRMA‐2 2001

Methods	Country: Denmark Setting/Design: Muticentre Time frame: NS Randomisation method: NS Blinding ‐ Participants: Yes ‐ Investigators: Yes ‐ Outcome assessors: No ‐ Data analysis: No Intention‐to‐treat: Yes Follow‐up period: 2 years Loss to follow‐up: 77
Participants	Inclusion criteria Hypertensive patients with type 2 DM Age: 30‐70 years Persistent microalbuminuria (AER 20‐200 µg/min in 2 of 3 consecutive, sterile, overnight urine samples) SCr ≤ 1.5 mg/dL for men and ≤ 1.1 mg/dL for women Irbesartan group 1 Number:195 Age: 58.4 (8) Sex (M/F): 129/66 Irbesartan group 2 Number: 194 Age: 57.3 (7.9) Sex (M/F): 137/57 Placebo group Number: 201 Age: 58.3 (8.7) Sex (M/F): 138/63 Exclusion criteria Non‐diabetic kidney disease Cancer Life‐threatening disease with death expected to occur within 2 years Indication for ACEi or AIRA
Interventions	Irbesartan group 1 150 mg/d Irbesartan group 2 300 mg/d Placebo group Co‐interventions Diuretics, beta‐blockers, CCB (except dihydropyridines), and alpha blockers
Outcomes	Incidence of progression to diabetic nephropathy AER CrCl BP
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear