Phase IIb Clinical Trial for the Efficacy and Safety by CU01-1001 for 24 Weeks in Type 2 DM Patients With Albuminuria
A Multi-center, Randomized, Double-blinded, Placebo-controlled, Parallel Phase IIb Clinical Trial for the Efficacy Assessment and Safety Evaluation by Treating CU01-1001 for 24 Weeks in Type 2 Diabetic Nephropathy Patients With Albuminuria
1 other identifier
interventional
240
1 country
24
Brief Summary
To evaluate the efficacy and safety of CU01-1001 administered for 24 weeks in type 2 diabetic nephropathy patients with albuminuria.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2023
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 27, 2023
CompletedFirst Posted
Study publicly available on registry
February 8, 2023
CompletedStudy Start
First participant enrolled
February 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 12, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 12, 2025
CompletedMarch 27, 2026
March 1, 2026
2.7 years
January 27, 2023
March 26, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change rate of urinary albumin/creatinine ratio (UACR) at 24 weeks compared to baseline
Change rate of urinary albumin/creatinine ratio (UACR) at 24 weeks compared to baseline
Day 0, 24 weeks
Study Arms (3)
CU01-1001 (low dose)
EXPERIMENTAL1 Tab/3 times/day (CU01-1001 120 mg, Breakfast and Dinner; Placebo 120 mg, Lunch)
CU01-1001 (high dose)
EXPERIMENTAL1 Tab/3 times/day (CU01-1001 120 mg, Breakfast, Lunch, and Dinner)
Placebo
PLACEBO COMPARATOR1 Tab/3 times/day (Placebo, Breakfast, Lunch, and Dinner)
Interventions
Eligibility Criteria
You may qualify if:
- Male/female patients aged ≥ 30 years
- Patients diagnosed with type 2 diabetes prior to screening
- Patients who have been receiving a stable dose of either an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB) for at least 8 weeks prior to screening
- Patients who experienced albuminuria defined as a urine albumin-to-creatinine ratio (UACR) ≥ 100 mg/g within 52 weeks prior to screening, and with UACR between 100 and 1000 mg/g at the time of screening
- Patients with blood pressure ≤ 140/90mmHg at screening
- Patients with 25 ≤ estimated glomerular filtration rate (eGFR) ≤ 75ml/min/1.73m2 at screening
- Patients with HbA1c ≤ 9.0% at screening
You may not qualify if:
- Patients with a history of acute kidney injury (AKI) within 12 weeks prior to screening, or with an increase in serum creatinine (SCr) ≥ 0.3 mg/dL within 48 hours, or an increase to ≥ 1.5 times the baseline (lowest value within the prior 12 weeks)
- Patients with a history or current diagnosis of heart failure classified as New York Heart Association (NYHA) Class III or IV, or a history of hospitalization due to heart failure
- Patients with renal disease, including but not limited to:
- Non-diabetic kidney disease
- Urological disorders
- Nephrotic syndrome
- Patients with a history of hepatic disease or meeting any of the following criteria related to liver function:
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 3 × upper limit of normal (ULN)
- Total bilirubin \> 3 × ULN
- Patients with a white blood cell (WBC) count \< 2 × 10³/µL
- Patients with a lymphocyte count \< 0.5 × 10⁹/L
- Patients with hemoglobin \< 9 g/dL
- Patients with organic gastrointestinal disorders or chronic gastrointestinal diseases associated with clinically significant malabsorption at screening, including but not limited to:
- Short bowel syndrome
- Active Crohn's disease
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Pusan National University Hospital
Busan, South Korea
SoonChunHyang University Hospital Cheonan
Chuncheon, South Korea
Daegu Catholic University Medical Center
Daegu, South Korea
Keimyung University Dongsan Hospital
Daegu, South Korea
Kyungpook National University Chilgok Hospital
Daegu, South Korea
Yeongnam University Medical Center
Daegu, South Korea
Daejeon Eulji Medical Center, Eulji University
Daejeon, South Korea
Ajou University Hospital
Gyeonggi-do, South Korea
Hallym University Dongtan Sacred Heart Hospital
Gyeonggi-do, South Korea
Korea University Ansan Hospital
Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, South Korea
The Catholic University of Korea Bucheon St. Mary's Hospital
Gyeonggi-do, South Korea
Gachon University Gil Medical Center
Incheon, South Korea
Jeonbuk National University Hospital
Jeonju, South Korea
Hallym University Gangnam Sacred Heart Hospital
Seoul, South Korea
Kangbuk Samsung Hospital
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Kyung Hee University Hospital
Seoul, South Korea
Nowon Eulji University
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital
Seoul, South Korea
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, South Korea
Wonju Severance Christian Hospital
Wŏnju, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 27, 2023
First Posted
February 8, 2023
Study Start
February 14, 2023
Primary Completion
November 12, 2025
Study Completion
November 12, 2025
Last Updated
March 27, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share