Renal and Systemic Effects of NCX4016 in Patients With Type 2 Diabetes and Early Nephropathy
Status:
Terminated
Trial end date:
2004-08-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Mario Negri Institute for Pharmacological Research