Effect of Sulodexide in Early Diabetic Nephropathy
Condition: Diabetic Nephropathy
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Intervention: Sulodexide; Placebo
Intervention description: 100 mg sulodexide gelcaps; 0 mg gelcap
Intervention MeSH terms: Glucuronyl glucosamine glycan sulfate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1056.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetes; Diabetes Mellitus, Type 2; Albuminuria; Diabetic Nephropathy

Summary:

      The purpose of the study is to determine whether treatment with sulodexide is effective in
      reducing the level of urine albumin excretion in patients with early diabetic kidney disease
      expressed as microalbuminuria.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of type 2 diabetes

          -  Serum creatinine equal to or less than 1.5 mg/dL

          -  Microalbuminuria, defined by a urine albumin/creatinine ratio in men; 35- 200 mg
             albumin/G creatinine, in women; 45-200 mg albumin/G creatinine

          -  Blood pressure controlled to less than 150/90 mmHg

          -  Willing to change antihypertensive medication regimen if necessary

        Exclusion Criteria:

          -  Age of onset of type 2 diabetes <18 years;

          -  HbA1C >10.0%;

          -  Morbid obesity defined as a body mass index (BMI) >= 45 kg/m2;

          -  Type 1 (insulin-dependent; juvenile onset) diabetes;

          -  Renal disease as follows:

               -  Patients with known non-diabetic renal disease

               -  Renal allograft

          -  Absolute requirement for combination therapy of angiotensin converting enzyme
             inhibitors (ACEI) and angiotensin receptor blockers (ARB);

          -  Cardiovascular disease as follows:

               -  Unstable angina pectoris within 3 months of study entry;

               -  Myocardial infarction, coronary artery bypass graft surgery, or percutaneous
                  transluminal coronary angioplasty or stent placement within 3 months of study
                  entry;

               -  Transient ischemic attack within 3 months of study entry;

               -  Cerebrovascular accident within 3 months of study entry;

               -  Symptomatic heart failure requiring ACE inhibition;

               -  New York Heart Association Functional Class III or IV heart failure;

               -  Obstructive valvular heart disease or hypertrophic cardiomyopathy;

               -  Second or third degree atrioventricular block not successfully treated with a
                  pacemaker

          -  Need for chronic (>2 weeks) immunosuppressive therapy, including corticosteroids
             (excluding inhaled or nasal steroids);

          -  History of multiple drug allergies;

          -  New diagnosis of cancer or recurrent cancer within 5 years of screening ( (except
             non-melanoma skin cancer);

          -  Psychiatric disorder that interferes with the patient's ability to comply with the
             protocol;

          -  Inability to tolerate oral medication or a history of significant malabsorption;

          -  Inability to remain on a stable dose of the following class of medications 30 days
             prior to randomization and throughout the study:

               -  3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors (statins);

               -  Peroxisome proliferator-activated receptor gamma (PPAR gamma inhibitors
                  (glitazones);

               -  Cyclooxygenase-2 inhibitors (COX-2 inhibitors); or

               -  Non-steroidal anti-inflammatory drugs (NSAIDS);

          -  History of alcohol or other drug abuse within 12 months of study entry;

          -  Known human immunodeficiency virus (HIV) disease;

          -  Any other medical condition which renders the patient unable to or unlikely to
             complete the study, or which would interfere with optimal participation in the study
             or produce significant risk to the patient;

          -  Receipt of any investigational drugs (including placebo) within 30 days of enrollment;

          -  Evidence of hepatic dysfunction including total bilirubin >2.0 mg/dL or liver
             transaminase (AST or ALT) >3 times upper limit of normal;

          -  Anticipated surgery within trial period;

          -  Inability to cooperate with study personnel or history of noncompliance to medical
             regimen (i.e., patients who would be expected to comply poorly with treatment);

          -  Known allergies or intolerance to any heparin-like compound;

          -  Untreated urinary tract infection that would impact urinary protein values; or

          -  Prior exposure to sulodexide, either in a clinical setting or as a participant in
             another clinical study.