Effect of Evogliptin on Albuminuria in Patients With Type 2 Diabetes and Renal Insufficiency (NCT03667300) | Clinical Trial Compass
CompletedPhase 2
Effect of Evogliptin on Albuminuria in Patients With Type 2 Diabetes and Renal Insufficiency
South Korea209 participantsStarted 2017-03-16
Plain-language summary
In this multi-center, randomized, double-blind, active-controlled, phase II non-inferiority study, we aimed to test the non-inferiority of evogliptin vs linagliptin in terms of reduction of albuminuria at week 24 from baseline in patients with type 2 diabetes having renal insufficiency.
Who can participate
Age range20 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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 clin…