CClinicalTrials.gg
Sign In
CompletedNCT02214693Updated Aug 27, 2015

PK//PD/Tolerability Study of DA-1229(Evogliptin) in Renal Impaired Patients

A Phase 1 interventional study of DA-1229 in Renal Impairment, sponsored by Dong-A ST Co., Ltd.. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-08-27.

Sponsored by Dong-A ST Co., Ltd. · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
20 Years to 70 Years
Sex
All
01

Study summary

This is a clinical study to investigate the pharmacokinetics/pharmacodynamics and tolerability of DA-1229(Evogliptin) tabletin renal impaired patients.

02

Conditions studied

  • Renal Impairment

Browse trials for

Keywords

  • patients
03

In context

Renal Insufficiency

1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.

This study's enrollment of 30 is below the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.

Browse Renal Insufficiency studies →

Lead sponsor

Dong-A ST Co., Ltd. is the lead sponsor of 122 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age between 20 and 70
  • Weights between 50 and 90kg(Female : 40 and 90kg)
  • Volunteer who totally understands the progress of this clinical trials, makes decision by his free will, and signed a consent form to follow the progress
  • Stable results of estimated GFR in 4 months recently

Exclusion criteria

Exclusion Criteria:

  • Volunteer who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology, immunology, pulmonary, endocrine, hematooncology, cardiology, mental disorder)
  • Volunteer who had drug(DPP-4 inhibitor) hypersensitivity reaction
  • Volunteer who already participated in other trials in 2 months
  • Volunteer who had whole blood donation in 2 months, or component blood donation in 1 months or transfusion
05

Study design

Phase
Phase 1
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Group 1(Severe decrease in GFR)

    Severe decrease in GFR

    Drug: DA-1229

  • Experimental
    Group 2(Moderate decrease in GFR)

    Moderate decrease in GFR

    Drug: DA-1229

  • Experimental
    Group 3(Mild decrease in GFR)

    Mild decrease in GFR

    Drug: DA-1229

  • Experimental
    Group 4(Normal GFR)

    Normal GFR

    Drug: DA-1229

Interventions

  • DrugDA-1229

    Also known as: Evogliptin

06

What researchers measure

Primary outcomes

  1. Area Under Curve(AUC) last

    Time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 60, 72, 96, 120h post-dose

07

Study locations

1 site
  • Clinical Trial Center, Seoul National University Hospital
    Seoul, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02214693
Lead sponsor
Dong-A ST Co., Ltd.
Responsible party
Sponsor
First posted
Aug 12, 2014
Start date
Jul 2014
Primary completion
Mar 2015
Last update
Aug 27, 2015

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Renal Insufficiency→

Other studies from this sponsor

Dong-A ST Co., Ltd.

Start the discussion