A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, 24-Week Study to Evaluate the Safety and Tolerability of Pyridorin Pyridoxamine Dihydrochloride in Patients With Diabetic Nephropathy Associated With Type 1 or Type 2 Diabetes

Inclusion Criteria:

• Males and Females (non-pregnant and non-lactating) between 18 and 70 years of age with type 1 or type 2 diabetes

• Sitting blood pressure of <=170/100 mm Hg at weeks -2 and -1

• Hemoglobin A1C <=12% at week -2

• Patients with diagnosis of diabetic nephropathy as defined by

  1. Serum Creatinine <=2.0 mg/dL at weeks -2 and -1
  2. Urinary albumin excretion >=300 mg/24 hours at week -2
  3. Diagnosis of diabetic retinopathy

• Creatinine clearance >=40 mL/min at weeks -2 and -1

• Voluntary written consent to participate in this study

Exclusion Criteria:

• History of allergic or adverse response to any B vitamin
• History of major cardiovascular or cerebrovascular events
• History of cancer except adequately treated basal or squamous cell carcinoma of the skin
• History of diabetic ketoacidosis