Effect of Evogliptin on Albuminuria in Patients With Type 2 Diabetes and Renal Insufficiency
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0002982
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 210
•Men and women aged 20 years or older diagnosed with type 2 diabetes.
•subjects having a level of glycated hemoglobin (HbA1c) 7.0% or more, and 10% or less.
•subjects having urine albumin to creatinine ratio (UACR) 30 ug/mg or more, and 3000 ug/mg or less.
•subjects having estimated glomerular filtration rate (eGFR) 30 or more.
•subjects who had taken angiotensin II receptor blocker(ARB) or angiotensin-converting enzyme(ACE) inhibitors for more than 4 weeks.
•subjects having body mass index (BMI) 20kg/m2 or more, 40 kg/m2 or less.
•subjects who entirely understood all the process of clinical study protocol and voluntarily take part in the study and agree to follow rule of the study.
•subjects having type 1 diabetes, secondary diabetes, or gestational diabetes
•subjects who had a history of surgery of resection of more than a half length of stomach or intestine.
•subjects having more than three-fold higher levels of Aspartate Transaminase(AST) or Alanine Transaminase(ALT) than upper normal limit.
•subjects who had taken Dipeptidyl Peptidase4(DPP4)-inhibitor or glucagon-like peptide-1(GLP-1) analogue within 8 weeks prior to screening.
•subjects who had taken oral triple hypoglycemic agents within 8 weeks prior to screening
•subjects taking strong cytochrome P450 3A4(CYP3A4) inhibitors or strong cytochrome P450 3A4(CYP3A4) inducers
•subjects who are pregnants or breast feeding givers.
•subjects who are unsuitable for clinical trial participation based on clinical laboratory test results or other reasons (e.g. taking chemotherapy or radiation for treatment for cancers).
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage change in urine albumin-to-creatinine ratio (UACR) after 24 weeks compared to baseline (%)
- Secondary Outcome Measures
Name Time Method Change in urine albumin-to-creatinine ratio (UACR) after 12/24 weeks compared to baseline (mg/g);Change in glycated hemoglobin after 12/24 weeks compared to baseline;HbA1c : less than 6.5% / 7.0% at Week 12/24;Change in NAG (N-acetyl-ß-D-glucosaminidase) after 12/24 weeks compared to baseline (U/L);Change in urinary Cystatin-C after 12/24 weeks compared to baseline (mg/L);Change in Nephrin after 12/24 weeks compared to baseline (ug/g cr);Change in Glycated albumin after 12/24 weeks compared to baseline (%);Change in estimated glomerular filtration rate based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) method after 12/24 weeks compared to baseline (mL/min)