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

• Status: Completed
• Trial end date: 2019-05-14
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samsung Medical Center
• Treatments: Linagliptin

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).