Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00157586
Status:
COMPLETED
Last Update Posted:
2015-04-09
First Post:
2005-09-08
Brief Title:
Delapril and Manidipine for Nephroprotection in Diabetes DEMAND
Sponsor:
Mario Negri Institute for Pharmacological Research
Organization:
Mario Negri Institute for Pharmacological Research
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2006-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 US 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 mgday alone or combined to the CCB Manidipine 10 mgday 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
Detailed Description:
INTRODUCTION Optimal blood pressure glycemic and lipid control are of utmost importance to minimize the incidence and the progression of chronic renal and cardiovascular complications in patients with diabetes mellitus type 2 Whether angiotensin converting enzyme ACE inhibitors alone or combined to calcium channel blockers CCB may further reduce the incidence and progression of chronic complications is worth investigating
AIMS The primary aim of this study is to assess whether at comparable levels of optimal blood pressure and metabolic control the ACE inhibitor delapril alone or in combination with the dihydropyridine CCB manidipine slow the rate of glomerular filtration rate GFR decline as compared with placebo plus conventional antihypertensive therapy in patients with diabetes mellitus type 2 and hypertension The secondary aim of this study is to assess the effects of delapril and manidipine on the incidence of major cardiovascular events acute myocardial infarction ictus or stroke heart failure requiring hospitalization revascularization amputation and cardiovascular mortality
STUDY POPULATION 342 hypertensive type 2 diabetes patients with normo- or micro-albuminuria STUDY DESIGN This is a multicenter prospective randomized double-blind placebo-controlled study After a 12-week baseline period in which prohibited antihypertensive treatments ACE inhibitors angiotensin II receptor antagonists or dihydropyridine calcium channel blockers will be discontinued patients will be stratified according to their urinary albumin excretion rate in normo- and micro-albuminuric and then randomized to delapril alone 30 mgday delapril 30 mgday combined with manidipine 10 mgday or placebo given once daily in the morning for at least three years During the study systolic and diastolic blood pressure in all treatments groups will be maintained 120 and 80 mmHg respectively with fixed doses of study treatments and flexible doses of permitted antihypertensive therapy diuretics beta blockers alfa blockers centrally acting adrenergic blockers Blood pressure blood glucose concentrations and urinary albumin excretion rate will be monitored every three months Serum lipid concentrations and GFR estimated with the iohexol plasma clearance will be measured every six months
Primary and Secondary Variables The primary efficacy variable of this study is the rate of GFR decline The secondary efficacy variable will be the incidence of major cardiovascular events acute myocardial infarction ictus or stroke heart failure requiring hospitalization revascularization amputation and cardiovascular mortality
AIMS The primary aim of this study is to assess whether at comparable levels of optimal blood pressure and metabolic control the ACE inhibitor delapril alone or in combination with the dihydropyridine CCB manidipine slow the rate of glomerular filtration rate GFR decline as compared with placebo plus conventional antihypertensive therapy in patients with diabetes mellitus type 2 and hypertension The secondary aim of this study is to assess the effects of delapril and manidipine on the incidence of major cardiovascular events acute myocardial infarction ictus or stroke heart failure requiring hospitalization revascularization amputation and cardiovascular mortality
STUDY POPULATION 342 hypertensive type 2 diabetes patients with normo- or micro-albuminuria STUDY DESIGN This is a multicenter prospective randomized double-blind placebo-controlled study After a 12-week baseline period in which prohibited antihypertensive treatments ACE inhibitors angiotensin II receptor antagonists or dihydropyridine calcium channel blockers will be discontinued patients will be stratified according to their urinary albumin excretion rate in normo- and micro-albuminuric and then randomized to delapril alone 30 mgday delapril 30 mgday combined with manidipine 10 mgday or placebo given once daily in the morning for at least three years During the study systolic and diastolic blood pressure in all treatments groups will be maintained 120 and 80 mmHg respectively with fixed doses of study treatments and flexible doses of permitted antihypertensive therapy diuretics beta blockers alfa blockers centrally acting adrenergic blockers Blood pressure blood glucose concentrations and urinary albumin excretion rate will be monitored every three months Serum lipid concentrations and GFR estimated with the iohexol plasma clearance will be measured every six months
Primary and Secondary Variables The primary efficacy variable of this study is the rate of GFR decline The secondary efficacy variable will be the incidence of major cardiovascular events acute myocardial infarction ictus or stroke heart failure requiring hospitalization revascularization amputation and cardiovascular mortality
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None