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Renal and Systemic Effects of NCX4016 in Patients With Type 2 Diabetes and Early Nephropathy

NCT00157508 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2015-04-09

No results posted yet for this study

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 gastrointestinal toxicity. Recent research indicate that coupling a nitric oxide (NO)derivate to the aspirin moiety retains its therapeutic effects while avoiding its undesirable gastrointestinal side effects. NO has cytoprotective effects, such as blood flow modulation, mucus release and repair of mucosal injury. NCX4016, a NO-releasing derivative of acetylsalicilic acid, has been shown to retain the analgesic, anti-inflammatory and antithrombotic activity of aspirin, but with less gastrointestinal toxicity. In addition, preliminary data suggested that NCX4016 may restore insulin sensitivity in eNOS deficient mice.

This study was aimed to evaluate the activity of NCX4016, compared to aspirin, on albuminuria, insulin sensitivity and cardiac and renal hemodynamic in patients with type 2 diabetes mellitus. The patients after one month of placebo treatment, entered two 1-month treatments periods, with equivalent doses (800 mg of NCX4016, 325 mg of aspirin) of NCX4016 or aspirin.

Conditions

Interventions

DRUG

nitroaspirin

Sponsors & Collaborators

  • Mario Negri Institute for Pharmacological Research

    lead OTHER

Principal Investigators

  • Piero Ruggenenti, MD · Mario Negri Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-03-31
Completion
2004-08-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00157508 on ClinicalTrials.gov