Last reviewed · How we verify
A Multicenter, Randomized, Prospective, Double-blind Study to Evaluate the Nephroprotective Effect of Delapril Alone or Combined With Manidipine in Patients With Type 2 Diabetes
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.
Details
| Lead sponsor | Mario Negri Institute for Pharmacological Research |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 342 |
| Start date | 2002-02 |
| Completion | 2008-06 |
Conditions
- Type 2 Diabetes
Interventions
- Delapril, Delapril-Manidipine Fixed combination
Primary outcomes
- The rate of decline of glomerular filtration rate (GFR).GFR is measured at baseline,and at 6,12,18,24,30 and 36 months after randomization
Countries
Italy, Slovenia