<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02214693</url>
  </required_header>
  <id_info>
    <org_study_id>DA1229_RI_I</org_study_id>
    <nct_id>NCT02214693</nct_id>
  </id_info>
  <brief_title>PK//PD/Tolerability Study of DA-1229(Evogliptin) in Renal Impaired Patients</brief_title>
  <official_title>A Clinical Study to Investigate the Pharmacokinetics/Pharmacodynamics and Tolerability of DA-1229(Evogliptin) Tablet in Renal Impaired Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dong-A ST Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dong-A ST Co., Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a clinical study to investigate the pharmacokinetics/pharmacodynamics and&#xD;
      tolerability of DA-1229(Evogliptin) tabletin renal impaired patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area Under Curve(AUC) last</measure>
    <time_frame>Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 60, 72, 96, 120h post-dose</time_frame>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Renal Impairment</condition>
  <arm_group>
    <arm_group_label>Group 1(Severe decrease in GFR)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Severe decrease in GFR</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2(Moderate decrease in GFR)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Moderate decrease in GFR</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3(Mild decrease in GFR)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mild decrease in GFR</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 4(Normal GFR)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Normal GFR</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DA-1229</intervention_name>
    <arm_group_label>Group 1(Severe decrease in GFR)</arm_group_label>
    <arm_group_label>Group 2(Moderate decrease in GFR)</arm_group_label>
    <arm_group_label>Group 3(Mild decrease in GFR)</arm_group_label>
    <arm_group_label>Group 4(Normal GFR)</arm_group_label>
    <other_name>Evogliptin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 20 and 70&#xD;
&#xD;
          -  Weights between 50 and 90kg(Female : 40 and 90kg)&#xD;
&#xD;
          -  Volunteer who totally understands the progress of this clinical trials, makes decision&#xD;
             by his free will, and signed a consent form to follow the progress&#xD;
&#xD;
          -  Stable results of estimated GFR in 4 months recently&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Volunteer who has past or present history of any diseases following below.(liver&#xD;
             including hepatitis virus carrier, kidney, Neurology, immunology, pulmonary,&#xD;
             endocrine, hematooncology, cardiology, mental disorder)&#xD;
&#xD;
          -  Volunteer who had drug(DPP-4 inhibitor) hypersensitivity reaction&#xD;
&#xD;
          -  Volunteer who already participated in other trials in 2 months&#xD;
&#xD;
          -  Volunteer who had whole blood donation in 2 months, or component blood donation in 1&#xD;
             months or transfusion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Clinical Trial Center, Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>August 11, 2014</study_first_submitted>
  <study_first_submitted_qc>August 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <last_update_submitted>August 25, 2015</last_update_submitted>
  <last_update_submitted_qc>August 25, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 27, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>patients</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Renal Insufficiency</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02214693
org study id: DA1229_RI_I
nct id: NCT02214693
lead sponsor: 
has dmc: Yes
This is a clinical study to investigate the pharmacokinetics/pharmacodynamics and
      tolerability of DA-1229(Evogliptin) tabletin renal impaired patients.
allocation: Non-Randomized
intervention model: Parallel Assignment
masking: None (Open Label)
measure: 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
arm group label: Group 1(Severe decrease in GFR)
arm group type: Experimental
description: Severe decrease in GFR
arm group label: Group 2(Moderate decrease in GFR)
arm group type: Experimental
description: Moderate decrease in GFR
arm group label: Group 3(Mild decrease in GFR)
arm group type: Experimental
description: Mild decrease in GFR
arm group label: Group 4(Normal GFR)
arm group type: Experimental
description: Normal GFR
intervention type: Drug
intervention name: DA-1229
arm group label: Group 1(Severe decrease in GFR)
arm group label: Group 2(Moderate decrease in GFR)
arm group label: Group 3(Mild decrease in GFR)
arm group label: Group 4(Normal GFR)
other name: Evogliptin
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Renal Insufficiency