Effect of Evogliptin on Albuminuria in Patients With Type 2 Diabetes and Renal Insufficiency

Launched by SAMSUNG MEDICAL CENTER · Sep 10, 2018

Keywords

ClinConnect Summary

This is a multi-center, randomized, double-blind, active-controlled, phase II non-inferiority study. Evogliptin (Trade name, Suganon) is a new, novel dipeptidyl peptidase-4 (DPP4) inhibitor which reveals a favorable results on glucose-lowering effect in patients with diabetes. However, its effect on renal function in patients with diabetes has been uncertained. To compare the effect of evogliptin and linagliptin on the reduction of albuminuria, we will recruit a total of 210 patients with Type 2 diabetes and renal insufficiency and allocate the participants into evogliptin group and linagli...

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Eligibility criteria

• 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 clinical trial participation based on clinical laboratory test results or other reasons (e.g. taking chemotherapy or radiation for treatment for cancers).