Diabetic nephropathy is characterized by persistent albuminuria and loss of kidney function, and is the leading cause of end-stage renal disease. So far, there is no fundamental treatment available. ACE Inhibitors and Angiotensin Receptor Blocker (ARB) are effective only in improving the deterioration of initial symptoms, and can’t be used in end-stage renal disease. So, there are still many unmet medical needs.

The active pharmaceutical ingredient of this investigational product activates the pathway of Nrt2 (Nuclear factor erythroid 2-related factor 2) that is mainly involved in antioxidation in the body, leading to inhibition of TGF-β/Smad 3 signals, as well as effective inhibition of formation of extracellular matrix through promotion of antioxidation and anti-inflammatory & cellular protective effects. In the mice models of UUO (unilateral ureteral obstruction) and streptozotocin-induced diabetic nephropathy, such a new dual mechanism of action has shown an excellent therapeutic effect in diabetic nephropathy.

Hence, this study is to compare and examine the changes in albumin-to-creatinine ratio (ACR); changes in glomerular filtration rate (GFR); change in HOMA-β level; and changes in C-peptide at Week 6 and Week 12 post-dose relative to pre-dose in patients with a type 2 diabetic nephropathy orally receiving CU01-1001 120mg and placebo for 12 weeks respectively. In this study, the therapeutic efficacy and safety, and pharmacokinetics characteristics of CU01-1001 will be evaluated, which will contribute to the new treatment option against this indication.

Treatment

Subjects will provide a written consent to participate in this study and the personal information and sensitive information (medical history and concomitant medicines etc) will be collected. Subjects who meet inclusion/exclusion criteria will participate in this study. All subjects will be randomized to either study group (CU101-1001 120mg) or control group (placebo) in a ratio of 1:1 and 20 subjects will be included in each group.

Arm Label

Target Number of Participant

Arm Type

Arm Description

Take 1 tablet orally twice a day with food (12 weeks).

Arm Label

Target Number of Participant

Arm Type

Arm Description

Take 1 tablet orally twice a day with food (12 weeks).

Gender

Age

Description

1)	Male/female patients aged 30 years  or above
2)	Patients diagnosed as type 2 diabetes prior to screening
3)	Patients receiving ACE inhibitors (angiotensin-converting-enzyme inhibitor) or ARB (angiotensin II receptor blockers) for at least 8 weeks prior to screening
4)	Patients who experienced albuminuria (albumin to creatinine ratio) 30~1,500 mg/g Cr) at least twice prior to baseline, including screening results
5)	Patients with blood pressure ≤ 140/90mmHg at screening
6)	Patients with 30 ≤ GFR (glomerular filtration rate) ≤ 89ml/min/1.73m2 at screening
7)	Patients with 6.5 < HbA1c ≤ 10% at screening 
8)	Patients with hemoglobin ≥ 10g/dL at screening
9)	Patients who give voluntary consent to the study participation

1)	Patients with past medical history of acute renal failure within 12weeks prior to screening; or Increase in SCr ≥ 0.3 mg/dL within 48 hours; or an increase in SCr ≥ 1.5-fold from baseline (the lowest value) within 12 weeks; or urine output <0.5mg/kg/hour for 6 hours
2)	The patients  with renal disease 
; SCr > 2.0 mg/dL or non-diabetic renal, urinary disease andnephrotic patient
3)	Patients with medical history related liver disease and hepatic function as follows: ALT (alanine aminotransferase) or AST (aspartate aminotransferase) >2 X institutional upper limit of normal (ULN), or Total bilirubin >2 X institutional upper limit of normal (ULN) 
4)	Patients with malabsorption due to organic gastrointestinal disorder or chronic gastroenterological disorders at screening (short-bowel syndrome, active Crohn's disease, and ulcerative colitis, etc.)
5)	Patients with acute disease (including infectious diseases) at screening and who are thought to be unable to participate in the clinical study)
6)	Within 12 weeks of the informed consent, patients who had the diagnosis and procedures of the following cardiovascular diseases: cardiac failure (NYHA class III and IV), unstable angina pectoris, myocardial infarction, transient ischemic attack, cerebro-vascular accident, history of peripheral vascular disease or coronary artery bypass surgery, and percutaneous transluminal coronary angioplasty
7)	Patients with history of alcohol or drug abuse
8)	Patients with any allergic reaction to the investigational product or its components
9)	Patients who are planning to receive dialysis or renal transplantation within 36 weeks (9 months) in the future
10)	Patients who are expected to have lower compliance with protein-limited diets and the use of the study drug
11)	Women who are pregnant or breastfeeding a baby
12)	Women who are able to become pregnant and do not agree to use acceptable contraception as defined by the protocol; however, women of childbearing potential who have not gone sterility procedures can participate in the study only for negative pregnancy test, and should agree to maintain effective contraception (implants of intrauterine device or intrauterine system, double barrier contraception (condom, diaphragm, sponge or cervical cap with spermicide), oral contraceptives, sterilization, and total abstinence) throughout the study
13)	Patients who participated in other clinical study within 4 weeks of the participation in this study
14)	Patients who are not eligible for this study participation in the judgment of the principal investigator or sub-investigator
15)	Patients receiving fumaric acid derivatives (topical or systemic)

Albumin to creatinine ratio

12 weeks after IP administration

Albumin to creatinine ratio

6 weeks after IP administration

Glomerular filtration rate

6 weeks and 12 weeks after IP administration

Homeostasis model assessment (HOMA) - β

6 weeks and 12 weeks after IP administration

C-peptide

6 weeks and 12 weeks after IP administration