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

Sponsor
Samsung Medical Center
Study ID
NCT03667300
Phase
PHASE2
Status
Completed

Conditions

  • Albuminuria
  • Renal Insufficiency
  • Type2 Diabetes Mellitus

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Evogliptin — DRUG
    This group will take daily evogliptin 5mg per oral, not linagliptin.
  • Linagliptin — DRUG
    This group will take daily linagliptin 5mg per oral, not evogliptin

Study Details

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.

Key Dates

First listed
Sep 12, 2018
Start date
Mar 16, 2017
Status verified
Sep 2019
Primary completion
May 14, 2019
Completion
May 14, 2019

Study Design

Enrollment
209 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Evogliptin Group
    Intervention group will take daily evogliptin 5mg per oral, not linagliptin 5mg per oral
  • Active Comparator: Linagliptin Group
    Control group will take daily linagliptin 5mg per oral, not evogliptin 5mg per oral

Primary Outcome Measure

UACR percent change at Week 24 [ Time Frame: Week 24 ]

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