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

NCT ID: NCT03667300

Last Updated: 2019-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 209 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-16
• Study Completion Date: 2019-05-14

Brief 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.

Detailed Description

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 linagliptin group with a ratio of 1:1 after radomization from 10 hospitals. After the oral administration of evogliptin 5mg per day or linagliptin 5mg per day for 24 weeks, the percent change of urine albumin-to-creatinine ratio (UACR) at Week 24 and at baseline will be measured as a primary endpoint. In addition, the percent changes of UACR, hemoglobin A1c, Cystatin-C, Nephrin, N-acetyl-beta-D-glucosaminidase (NAG), glycated albumin, estimated glomerular filtration rate (eGFR) between baseline and Week 12 or Week 24 will be studied as secondary endpoints.

Conditions

Type2 Diabetes Mellitus; Albuminuria; Renal Insufficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Evogliptin Group

Intervention group will take daily evogliptin 5mg per oral, not linagliptin 5mg per oral

Group Type: ACTIVE_COMPARATOR

Evogliptin

Intervention Type: DRUG

This group will take daily evogliptin 5mg per oral, not linagliptin.

Linagliptin Group

Control group will take daily linagliptin 5mg per oral, not evogliptin 5mg per oral

Group Type: ACTIVE_COMPARATOR

Linagliptin

Intervention Type: DRUG

This group will take daily linagliptin 5mg per oral, not evogliptin

Interventions

Evogliptin

This group will take daily evogliptin 5mg per oral, not linagliptin.

Intervention Type: DRUG

Linagliptin

This group will take daily linagliptin 5mg per oral, not evogliptin

Intervention Type: DRUG

Other Intervention Names

Suganon; Trajenta

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).

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jae Hyeon Kim, MD, PhD

Professor / Division of Endocrinology and metabolism

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jae Hyeon Kim, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

2016-08-144

Identifier Type: -

Identifier Source: org_study_id