Status:
COMPLETED
Delapril and Manidipine for Nephroprotection in Diabetes (DEMAND)
Lead Sponsor:
Mario Negri Institute for Pharmacological Research
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
40-75 years
Phase:
PHASE3
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 e...
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 wit...
Eligibility Criteria
Inclusion
- Age ≥ 40 years
- History of diabetes mellitus type 2 for at least three months with stable antidiabetic treatment
- Systolic and/or diastolic blood pressure ≥ 135 or 85 mmHg, respectively. In alternative, antihypertensive therapy regardless of blood pressure values
- Serum creatinine ≤ 1.5 mg/dL
- Urinary albumin excretion rate \< 200 µg/min
- Written informed consent for the trial participation.
Exclusion
- Clinical or histological evidence of non-diabetic renal disease, including vascular disease of the kidney, obstructive uropathy, prostatic hypertrophy or incomplete bladder emptying
- Transplanted kidney
- Moderate to severe chronic heart failure (III-IV stage according to the NYHA classification).
- Cerebral hemorrhage, stroke or transient ischemic attack within three months prior to the trial enrolment
- Myocardial infarction within three months prior to the trial enrolment
- Unstable angina pectoris
- Mitral valve stenosis, aortic stenosis or hypertrophic cardiomyopathy
- Secondary (e.g., Cushing disease, phaeochromocytoma, etc.) or severe refractory hypertension
- Poor glycemic control (HbA1c\>11%)
- Connective tissue or autoimmune disease
- Hereditary angioneurotic edema
- Clinically relevant electrolyte imbalance (e.g., serum potassium \> 5.5 mmol/L)
- Clinically relevant hematological disorders
- Anemia with hemoglobin concentrations \< 10 g/dL
- Serious hepatic disease
- Pregnancy or lactating or planning a pregnancy
- Women of childbearing potential without following a scientifically accepted form of contraception
- Any other serious or terminal concomitant disease
- Any condition which may interfere with the absorption of the study treatments
- Any concomitant treatment with ACE inhibitors, angiotensin II blockers, calcium channel blockers, potassium sparing diuretics
- Chronic treatment with nonsteroidal antiinflammatory drugs, antidepressants and neuroleptics, lithium, cimetidine, immunosuppressive and/or antineoplastic drugs, chronic systemic glucocorticoid therapy more than 7 consecutive days in one month, antiarrhythmic drugs (e.g., chinidin, procainamide), anesthetics/narcotics
- History of hypersensitivity to delapril or other ACE inhibitors, manidipine or other dihydropyridine CCBs
- Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the trial
- Evidence of an uncooperative attitude
- Any evidence that allows predicting that the patient will not be able to complete the trial follow-up.
Key Trial Info
Start Date :
February 1 2002
Trial Type :
INTERVENTIONAL
End Date :
June 1 2008
Estimated Enrollment :
342 Patients enrolled
Trial Details
Trial ID
NCT00157586
Start Date
February 1 2002
End Date
June 1 2008
Last Update
April 9 2015
Active Locations (8)
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1
Hospital "Ospedali Riuniti di Bergamo" - Diabetologic Unit
Bergamo, Bergamo, Italy, 24128
2
ASL of Ponte San Pietro - Diabetologic Unit
Ponte San Pietro, Bergamo, Italy, 24036
3
Clinical Research Center for Rare Diseases
Ranica, Bergamo, Italy, 24020
4
Hospital of Romano di Lombardia - Diabetologic Unit
Romano di Lombardia, Bergamo, Italy, 24058