Delapril and Manidipine for Nephroprotection in Diabetes (DEMAND)
Status:
Completed
Trial end date:
2008-06-01
Target enrollment:
Participant gender:
Summary
Diabetes mellitus is one of the most common diseases globally, and is considered epidemic in
many developed and newly industrialized nations. Diabetes mellitus represents the single
largest cause of end-stage renal disease in the U.S. and Europe. At the same time, the
primary cause of early death in diabetic patients are cardiovascular complications.
Experimental and clinical studies found that angiotensin converting enzyme inhibitors (ACEi)
and calcium channel blockers (CCBs) have a specific renoprotective effect and that this
effect can be magnified when the two drugs are used in combination. To formally test this
hypothesis we designed the Delapril and Manidipine for Nephroprotection in Diabetes (DEMAND)
study, a prospective, randomized, double blind trial aimed to compare the effect of 3 years
treatment with the ACEi Delapril (30 mg/day), alone or combined to the CCB Manidipine (10
mg/day), versus conventional (non ACEi, non CCB) therapy on the rate of renal function loss
and on the incidence of major cardiovascular events in 342 normo- and micro-albuminuric
hypertensive type 2 diabetic patients.
Phase:
Phase 3
Details
Lead Sponsor:
Mario Negri Institute for Pharmacological Research