A multi-center, randomized, double-blind, active-controlled, phase II non-inferiority, investigator-initiated clinical trial to investigate the effect on kidney and diabetes of evogliptin after oral administration in patients with impaired renal function and type 2 diabetes

Samsung Medical Center0 个研究点目标入组 210 人开始时间: 待定最近更新: 2019年3月11日

试验速览

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•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).

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