Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03667300
Study type Interventional
Source Samsung Medical Center
Contact
Status Completed
Phase Phase 2
Start date March 16, 2017
Completion date May 14, 2019

See also
  Status Clinical Trial Phase
Completed NCT05990660 - Renal Assist Device (RAD) for Patients With Renal Insufficiency Undergoing Cardiac Surgery N/A
Recruiting NCT04096547 - Rivaroxaban in Elderly NVAF Patients With or Without Renal Impairment
Completed NCT04024332 - Study of the Way the Body Takes up, Distributes, and Gets Rid of ACT-541468 in Subjects With Abnormal Kidney Function Compared to Healthy Subjects Phase 1
Completed NCT02849964 - Factors Related to Geographical Variation in the Incidence of End-stage Renal Failure: An Analysis in 5 French Regions N/A
Active, not recruiting NCT03672110 - Slow and Low Start of a Tacrolimus Once Daily Immunosuppressive Regimen Phase 3
Completed NCT01407874 - A Randomized, Double-Blind, Dose-Response Study of the Safety and Uric Acid Effects of Oral Ulodesine Added to Allopurinol in Subjects With Gout and Concomitant Moderate Renal Insufficiency Phase 2
Completed NCT01462136 - PK Study of ACHN-490 Injection in Renally Impaired Subjects Phase 1
Completed NCT01172431 - Indapamide Versus Hydrochlorothiazide in Elderly Hypertensive Patients With Renal Insufficiency Phase 4
Completed NCT00765830 - Safety and Tolerability of Vildagliptin Versus Placebo in Patients With Type 2 Diabetes and Moderate or Severe Renal Insufficiency (28 Week Extension) Phase 3
Completed NCT00770081 - Safety and Tolerability of Vildagliptin Versus Sitagliptin in Patients With Type 2 Diabetes and Severe Renal Insufficiency (28-week Extension Study) Phase 3
Completed NCT01545531 - Two-Point Measurement of Glomerular Filtration Rate by Iohexol Plasma Disappearance N/A
Terminated NCT00338455 - Natrecor (Nesiritide) in Transplant-Eligible Management of Congestive Heart Failure-TMAC Phase 2
Completed NCT00159614 - Effect of KW-3902IV in Combination With IV Furosemide on Renal Function in Subjects With CHF and Renal Impairment Phase 2
Completed NCT02894905 - A Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of AL-335 Phase 1
Completed NCT02894385 - Effect of Hepatic and Renal Impairment on the Pharmacokinetics, Safety and Tolerability of BAY1841788 (ODM-201) Phase 1
Active, not recruiting NCT04876963 - HOLT-ED: Holter-monitoring in End-stage Renal Disease
Not yet recruiting NCT03899298 - Safety and Clinical Outcomes With Amniotic and Umbilical Cord Tissue Therapy for Numerous Medical Conditions Phase 1
Completed NCT03235375 - A Study to Evaluate Pharmacokinetics, Safety and Tolerability of MEDI0382 in Renal Impairment Subjects Phase 1
Withdrawn NCT03329612 - Remote Ischemic Preconditioning in ACS Patients N/A
Recruiting NCT02578784 - DEB-after-Cutting Balloon-PTA in Dialysis Fistula Stenosis N/A