Type 2 Diabetes Clinical Trial
Official title:
A Pilot, Randomised, Double-blind, Cross-over Study to Assess the Renal and Systemic Effects of NCX4016 in Patients With Type 2 Diabetes and Early Nephropathy
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.
Status | Terminated |
Enrollment | 13 |
Est. completion date | August 2004 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Italy | Clinical Research Center for Rare Diseases | Ranica | Bergamo |
Lead Sponsor | Collaborator |
---|---|
Mario Negri Institute for Pharmacological Research |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Albuminuria after 4 weeks of treatment | |||
Primary | Insulin sensitivity after 4 weeks of treatment | |||
Primary | Cardiac and renal hemodynamics after 4 weeks of treatment |
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