Efficacy and Safety Study of Probucol in Patients With Diabetic Nephropathy

• Usage: 16 week, BID, Prescribed Oral with the breakfast and dinner
• Dosage:Placebo group: placebo 2 tablets, 16 weeks Probucol 250mg group: probucol 125mg 2 tablets, 16 weeks Probucol 500mg group: probucol 250 mg 2 tablets, 16 weeks

Inclusion criteria

• The subject is male or female diagnosed with type 2 diabetes mellitus and must be aged 20 to 75 years at the time of screening visit
• Urinary albumin excretion > 300 mg/g Cr at screening visit
• Subjects administered ACEI or ARB without changing dosage prior to 3 months at the screening visit (if subjects administered ACEI or ARB)
• Subjects administered statins without changing dosage prior to 3 months at the screening visit(if subjects administered statins) or subjects have no plan to administered to statin(if subjects is not administered statin)
• 15 mL/min ≤ eGFR ≤ 90 mL min
• Subjects must be willing and able to give signed and dated written informed consent.

Exclusion criteria

• Type 1 DM or gestational diabetes
• Subjects on Renal replacement therapy or Renal transplantation prior to Screening visit
• Ventricular arrhythmia (multiple and multifocal premature ventricular contractions)
• Cardiac damage (abnormally levels of Troponin I)
• Subject with medical history of cardiac syncope or primary syncope
• Has condition that may prolong QTc interval (for man QTc interval>450msec, for woman QTc interval>470msec) at screening
• Pregnant or lactating woman before randomization
• Inflammatory bowel disease (ulcerative colitis, Crohn's disease)
• Cholestasis
• Congestive heart failure
• Subjects with a myocardial infarction, Unstable angina, or cerebral infarction within the latest 6 months
• Subjects has a diagnosis of NYHA grade III-IV status
• AST or ALT is 3.0 times higher than the upper limit of the normal range
• Active hepatitis Or Liver cirrhosis
• Subjects with Hyperkalemia (K>5.5 mEq/L)
• Subjects with Renal Artery stenosis
• Subjects with Malignancy within the 5 years at the time of screening visit(except for treated Basal cells carcinoma or squamous cell carcinoma)
• Urinary tract disease (urinary tract infection, Neurogenic bladder)
• Kidney disease (nephritis, chronic glomerulonephritis or polycystic kidney disease)
• Has an allergic history to probucol
• HbA1c > 9%
• Systolic blood pressure ≥ 160 mmHg or Diastolic blood pressure ≥ 100 mmHg
• Subjects taken probucol within 3 months prior to Screening
• The subject has received an investigational product or biological agent within 3 months prior to screening
• Subjects otherwise judged by the investigator or sub investigator to be inappropriate for inclusion in the trial