<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/NCT02974504</url>
  </required_header>
  <id_info>
    <org_study_id>DA1229_DM_IV</org_study_id>
    <nct_id>NCT02974504</nct_id>
  </id_info>
  <brief_title>Phase IV Clinical Trial to Investigate the Effect on Blood Glucose of Evogliptin in Patients With Type 2 Diabetes(EVERGREEN)</brief_title>
  <official_title>A Multicenter, Randomized, Double-blind, Active-contrelled, Parallel-group, Phase IV Clinical Trial to Investigate the Effect on Blood Glucose of Evogliptin After Oral Administration in Patiend With Type 2 Diabetes</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>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A multi-center, randomized, double-blind, active-controlled, parallel group, phase IV&#xD;
      clinical trial to investigate the effect on blood glucose of evogliptin after oral&#xD;
      administration in patients with type 2 diabetes&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Evogliptin 5mg Group: Administration with Evogliptin 5mg for 0-24 weeks.&#xD;
&#xD;
        2. Liniagliptin 5mg Group: Administration with linagliptin 5mg for 0-12 weeks, and with&#xD;
           Evogliptin 5mg for 13-24 weeks&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2016</start_date>
  <completion_date type="Actual">March 2018</completion_date>
  <primary_completion_date type="Actual">March 2018</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>HbA1c</measure>
    <time_frame>Change from baseline at 12 week</time_frame>
    <description>unit: %</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>fasting plasma glucose</measure>
    <time_frame>Change from baseline at 12 week</time_frame>
    <description>unit : mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HbA1c response rate</measure>
    <time_frame>Change from baseline at 12 weeks</time_frame>
    <description>unit: %</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">207</enrollment>
  <condition>Type2 Diabetes</condition>
  <arm_group>
    <arm_group_label>evogliptin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>evogliptin 5mg qd</description>
  </arm_group>
  <arm_group>
    <arm_group_label>linagliptin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>linagliptin 5mg qd</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>evogliptin</intervention_name>
    <description>evogliptin 5mg tablet qd + placebo tablet matching to linagliptin 5mg</description>
    <arm_group_label>evogliptin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Linagliptin</intervention_name>
    <description>linagliptin 5 mg tablet qd + placebo tablet matching to evogliptin 5mg</description>
    <arm_group_label>linagliptin</arm_group_label>
    <other_name>Tragenta</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects with 7.0%≤HbA1c≤10.0% at screening&#xD;
&#xD;
               -  Subjects untreated with oral hypoglycemic agents within 8 weeks prior to&#xD;
                  screening&#xD;
&#xD;
          -  Subjects with 20kg/m2≤BMI≤40kg/m2 at screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with fasting plasma glucose≥270mg/dL at screening&#xD;
&#xD;
          -  Patients with type 1 diabetes mellitus, secondary diabetes mellitus or gestational&#xD;
             diabetes mellitus&#xD;
&#xD;
          -  Subjects with history of myocardial infarction, cerebral infarction within 24 weeks&#xD;
             prior to screening&#xD;
&#xD;
          -  Subjects with ALT and AST 3 times or higher than upper normal range&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Division of Endocrinology and Metabolism, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2016</study_first_posted>
  <last_update_submitted>July 19, 2018</last_update_submitted>
  <last_update_submitted_qc>July 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Linagliptin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02974504
org study id: DA1229_DM_IV
nct id: NCT02974504
lead sponsor: 
has dmc: No
A multi-center, randomized, double-blind, active-controlled, parallel group, phase IV
      clinical trial to investigate the effect on blood glucose of evogliptin after oral
      administration in patients with type 2 diabetes
1. Evogliptin 5mg Group: Administration with Evogliptin 5mg for 0-24 weeks.

        2. Liniagliptin 5mg Group: Administration with linagliptin 5mg for 0-12 weeks, and with
           Evogliptin 5mg for 13-24 weeks
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: HbA1c
time frame: Change from baseline at 12 week
description: unit: %
measure: fasting plasma glucose
time frame: Change from baseline at 12 week
description: unit : mg/dL
measure: HbA1c response rate
time frame: Change from baseline at 12 weeks
description: unit: %
arm group label: evogliptin
arm group type: Experimental
description: evogliptin 5mg qd
arm group label: linagliptin
arm group type: Active Comparator
description: linagliptin 5mg qd
intervention type: Drug
intervention name: evogliptin
description: evogliptin 5mg tablet qd + placebo tablet matching to linagliptin 5mg
arm group label: evogliptin
intervention type: Drug
intervention name: Linagliptin
description: linagliptin 5 mg tablet qd + placebo tablet matching to evogliptin 5mg
arm group label: linagliptin
other name: Tragenta
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Linagliptin
sharing ipd: No