<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/NCT03011177</url>
  </required_header>
  <id_info>
    <org_study_id>MP_C402</org_study_id>
    <nct_id>NCT03011177</nct_id>
  </id_info>
  <brief_title>Teneligliptin Versus Linagliptin in Diabetes Mellitus Type Two Patients</brief_title>
  <acronym>TELIUS</acronym>
  <official_title>A Randomized, Open Label, Parallel-group, Non-inferiority, Active-controlled, Phase Ⅳ Study to Evaluate the Efficacy and Safety of Teneligliptin Versus Linagliptin in Type 2 Diabetes Mellitus Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Handok Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Handok Inc.</source>
  <brief_summary>
    <textblock>
      To assess the efficacy and safety of Teneligliptin and Linagliptin in the type 2 Diabetes&#xD;
      Mellitus patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized, open label, parallel-group, non-inferiority, active-controlled, phase IV study&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">September 2018</completion_date>
  <primary_completion_date type="Actual">September 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>HbA1c</measure>
    <time_frame>12week</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">168</enrollment>
  <condition>Type2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>teneligliptin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>teneligliptin 20mg 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>Teneligliptin</intervention_name>
    <description>teneligliptin 20mg qd</description>
    <arm_group_label>teneligliptin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Linagliptin</intervention_name>
    <description>linagliptin 5mg qd</description>
    <arm_group_label>linagliptin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who are 19 years or older on screening&#xD;
&#xD;
          -  Patients with type 2 diabetes mellitus&#xD;
&#xD;
          -  Patients with 7.0% ≤ HbA1c ≤ 11.0% at the screening visit&#xD;
&#xD;
          -  Patients with Fasting Plasma Glucose &lt;15mmol/L(270mg/dL) on screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>February 20, 2019</last_update_submitted>
  <last_update_submitted_qc>February 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 22, 2019</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>
  <!-- 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/NCT03011177
org study id: MP_C402
nct id: NCT03011177
lead sponsor: 
To assess the efficacy and safety of Teneligliptin and Linagliptin in the type 2 Diabetes
      Mellitus patients.
A randomized, open label, parallel-group, non-inferiority, active-controlled, phase IV study
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: HbA1c
time frame: 12week
arm group label: teneligliptin
arm group type: Experimental
description: teneligliptin 20mg qd
arm group label: linagliptin
arm group type: Active Comparator
description: linagliptin 5mg qd
intervention type: Drug
intervention name: Teneligliptin
description: teneligliptin 20mg qd
arm group label: teneligliptin
intervention type: Drug
intervention name: Linagliptin
description: linagliptin 5mg qd
arm group label: linagliptin
criteria: 
gender: All
minimum age: 19 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