NCT03667300

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

Evogliptin Versus Linagliptin for the Effect on Albuminuria in Patients With Type 2 Diabetes and Renal Insufficiency: a Multicenter, Randomised, Double-blind, Active-controlled, Non-inferiority Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 209 (actual)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Evogliptin	This group will take daily evogliptin 5mg per oral, not linagliptin.
DRUG	Linagliptin	This group will take daily linagliptin 5mg per oral, not evogliptin

Timeline

• Start date: 2017-03-16
• Primary completion: 2019-05-14
• Completion: 2019-05-14
• First posted: 2018-09-12
• Last updated: 2019-09-23

Locations

1 site across 1 country: South Korea