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

NCT03667300 | Completed Phase 2

• 1 other identifier: 2016-08-144
• Study Type: interventional
• Target: 209
• Locations: 1 country
• Sites: 1

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.

Conditions

Type2 Diabetes Mellitus; Albuminuria; Renal Insufficiency

Keywords

Type2 Diabetes Mellitus; Intervention; Albuminuria

Outcome Measures

Primary Outcomes (1)

• UACR percent change at Week 24

  Percentage change in urine albumin-to-creatinine ratio (UACR) after 24 weeks compared to baseline (%)

  Week 24

Secondary Outcomes (18)

• UACR change at Week 24 (%)

  Week 24

• UACR change at Week 12

  Week 12

• HbA1c change at Week 24

  Week 24

• HbA1c change at Week 12

  Week 12

• HbA1c less than 6.5% at Week 24

  Week 24

Study Arms (2)

Evogliptin Group

ACTIVE COMPARATOR

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

Drug: Evogliptin

Linagliptin Group

ACTIVE COMPARATOR

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

Drug: Linagliptin

Interventions

Evogliptin DRUG

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

Also known as: Suganon

Evogliptin Group

Linagliptin DRUG

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

Also known as: Trajenta

Linagliptin Group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Albuminuria; Renal Insufficiency

Interventions

4-(3-amino-4-(2,4,5-trifluorophenyl)butanoyl)-3-(tert-butoxymethyl)piperazin-2-one; Linagliptin

Condition Hierarchy (Ancestors)

Proteinuria; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Kidney Diseases

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinazolines

Study Officials

• Jae Hyeon Kim, MD PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor / Division of Endocrinology and metabolism

Study Record Dates

• First Submitted: February 20, 2018
• First Posted: September 12, 2018
• Study Start: March 16, 2017
• Primary Completion: May 14, 2019
• Study Completion: May 14, 2019
• Last Updated: September 23, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)