Status:
TERMINATED
Renal and Systemic Effects of NCX4016 in Patients With Type 2 Diabetes and Early Nephropathy
Lead Sponsor:
Mario Negri Institute for Pharmacological Research
Conditions:
Type 2 Diabetes
Early Nephropathy
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Aspirin is commonly used for treatment of painful and inflammatory diseases and in the prevention of the cardiovascular disease. A major drawback of aspirin treatment is the well recognized gastrointe...
Detailed Description
Nitric oxide-releasing, non-steroidal anti-inflammatory drugs (NO-NSAIDs) are new chemical entities obtained by adding a nitric oxide-releasing moiety to the parent NSAID via a short-chain ester linka...
Eligibility Criteria
Inclusion
- Male and female patients affected by type 2 diabetes with stable metabolic control (HbA1c \< 9%), and stable systemic blood pressure control (SBP/ DBP \< 160/90 mmHg).
- Presence of early nephropathy (overnight albumin excretion rate \> 20 microg/ min for at least 6 months), without overt renal insufficiency (serum creatinine concentration \< 2 mg/dl).
- Age between 18 and 75 years.
- Written signed informed consent; patient willing and able to comply with all study procedures and scheduled visits.
Exclusion
- History of any form of allergic reactions or hypersensitivity or intolerance or contraindication to acetylsalicylic acid or nitrates.
- Patients under the age of 18 or above 75.
- Patients who are not able to give an informed consent or inadequate comprehension of study risks and requirements.
- Patients who are unable to comply with the requirements of the study protocol.
- Chronic alcohol or drug abuse (current or within the past year).
- Pregnancy and lactation.
- If women of child-bearing potential, a pregnancy test must be performed before inclusion and after the study, and reliable contraceptive methods followed.
- Evidence for non-diabetic renal disease.
- Patients with duodenal/gastric ulcer history, or gastrointestinal bleeding over the last 6 months.
- Patients with liver insufficiency (ASAT, ALAT \> 2 times the upper normal limit).
- Patients with platelet counts \< 100,000 cells/mm3.
- Patients with hemorrhagic diathesis.
- Patients on antiinflammatory or immunosuppressive therapy over the last 6 months.
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
End Date :
August 1 2004
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00157508
Start Date
March 1 2003
End Date
August 1 2004
Last Update
April 9 2015
Active Locations (1)
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1
Clinical Research Center for Rare Diseases
Ranica, Bergamo, Italy, 24020