Rationale and design of diabetics exposed to telmisartan and enalapril (DETAIL) study

Abstract

The DETAIL (diabetics exposed to telmisartan and enalapril) study will compare the long-term renal outcome of treatment with the angiotensin II receptor antagonist (ARA) telmisartan versus the angiotensin-converting enzyme (ACE) inhibitor enalapril in patients with mild-to-moderate hypertension and diabetic nephropathy. In short-term clinical studies, ACE inhibitors reduce microalbuminuria and, in the longer term, they are superior to conventional therapies in maintaining normal renal function. ARAs also appear to be renoprotective in diabetic animals. In this double-blind, parallel-group study, 252 patients with Type 2 diabetes and concurrent hypertension (mean seated systolic blood pressure < or = 180 mm Hg, on treatment seated diastolic blood pressure < or = 95 mm Hg) have been randomised to once-daily telmisartan 40 mg or enalapril 10 mg; doses are mandatorily titrated to 80 and 20 mg once daily, respectively, after 4 weeks. The primary endpoint will be the change from baseline in glomerular filtration rate (GFR) after 5 years of therapy, using the iohexol method and central laboratory analysis. The secondary endpoints to be evaluated will be: changes in GFR in relation to baseline after 1-4 years of therapy; percentage changes in albumin excretion rate after 1-5 years; and incidences of end-stage renal disease, cardiovascular events, all-cause mortality, and adverse events. The planned date for the completion of the study is 2005.