<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/NCT03793023</url>
  </required_header>
  <id_info>
    <org_study_id>HD_TEN_OS2015</org_study_id>
    <nct_id>NCT03793023</nct_id>
  </id_info>
  <brief_title>Observational Study to Evaluate the Efficacy and Safety of Teneligliptin</brief_title>
  <official_title>Observational Study to Evaluate the Efficacy and Safety of Teneligliptin When Switched From Other DPP-4 Inhibitors in Type 2 DM With Inadequate Glycemic Control</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Handok Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Handok Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed as a prospective, observational, multi-centre study to evaluate the&#xD;
      efficacy and safety of Teneligliptin when switched from other DPP-4 inhibitors in type 2 DM&#xD;
      with inadequate glycemic control&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 2016</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in HbA1c</measure>
    <time_frame>at 12 weeks after switching to Teneligliptin</time_frame>
    <description>To assess change from baseline in glycated hemoglobin (HbA1c)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in HbA1c</measure>
    <time_frame>at 24, 52 weeks after switching to Teneligliptin</time_frame>
    <description>To assess change from baseline in HbA1c</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in FBG</measure>
    <time_frame>at 12, 24, 52 weeks after switching to Teneligliptin</time_frame>
    <description>To assess change from baseline in fasting blood glucose (FBG)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in body weight, BMI</measure>
    <time_frame>at 12, 24, 52 weeks after switching to Teneligliptin</time_frame>
    <description>To assess change from baseline in body weight and body mass index (BMI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in lipid profile(Total cholesterol, LDL cholesterol, HDL cholesterol)</measure>
    <time_frame>at 12, 24, 52 weeks after switching to Teneligliptin</time_frame>
    <description>To assess change from baseline in serum lipid profile (total cholesterol, LDL and HDL cholesterol, triglyceride)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The percentage of patients with HbA1c &lt;7.0% and &lt;6.5%</measure>
    <time_frame>at Weeks 12, 24, and 52 of teneligliptin treatment</time_frame>
    <description>To assess the percentage of patients with HbA1c &lt;7.0% and &lt;6.5%</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The percentage of patients with a decrease from baseline in HbA1c</measure>
    <time_frame>at Weeks 12, 24, and 52 of teneligliptin treatment</time_frame>
    <description>To assess the percentage of patients with a decrease from baseline in HbA1c by ≥0.3% and ≥ 0.5%</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety Outcome</measure>
    <time_frame>at Weeks 12, 24, and 52 of teneligliptin treatment</time_frame>
    <description>To assess the safety of teneligliptin treatment(AE, ADR, SAE etc.)</description>
  </secondary_outcome>
  <enrollment type="Anticipated">4875</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Teneligliptin 20mg</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Type 2 DM patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The subject is aged ≥19 years&#xD;
&#xD;
          2. The subject has a documented diagnosis of type 2 diabetes mellitus for at least 3&#xD;
             months at the screening visit.&#xD;
&#xD;
          3. Patient who was treated with same dosage of DPP4 inhibitor for at least 12 weeks prior&#xD;
             to baseline visit (if patient who has been treated with DPP4 inhibitor and any other&#xD;
             antidiabetic drugs, antidiabetic drugs should also have been kept same dosage for at&#xD;
             least 12 weeks prior to baseline.)&#xD;
&#xD;
          4. Patient with HbA1c≥7.0% at baseline visit&#xD;
&#xD;
          5. Patient who can be switched to Teneligliptin instead of using DPP-4 inhibitor for&#xD;
             glycemic control based on the investigator's judgment&#xD;
&#xD;
          6. Patient (or legal guardian, if applicable) is informed of the full nature and purpose&#xD;
             of the study, including possible risks and side effects, and understand this&#xD;
             information, voluntarily signed and dated the written informed consent in compliance&#xD;
             with protocol before inclusion in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient with hypersensitivity to the Teneligliptin&#xD;
&#xD;
          2. Patient who treat the Teneligliptin prior to baseline visit&#xD;
&#xD;
          3. A pregnant or lactating female patient&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Kwan Woo Lee, MD, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ajou University School of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yeokyung Kim, CRM</last_name>
    <phone>+82-2-527-5332</phone>
    <email>YeoKyeong.Kim@handok.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yesung Jang, CRA</last_name>
    <phone>+82-2-527-5383</phone>
    <email>yesung.Jang@handok.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Ajou University Hospital</name>
      <address>
        <city>Suwon</city>
        <state>Gyeonggi</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kwan Woo Lee, M.D, Ph.D</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>January 3, 2019</last_update_submitted>
  <last_update_submitted_qc>January 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 7, 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, Type 2</mesh_term>
  </condition_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/NCT03793023
org study id: HD_TEN_OS2015
nct id: NCT03793023
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is designed as a prospective, observational, multi-centre study to evaluate the
      efficacy and safety of Teneligliptin when switched from other DPP-4 inhibitors in type 2 DM
      with inadequate glycemic control
observational model: Case-Crossover
time perspective: Prospective
measure: Change in HbA1c
time frame: at 12 weeks after switching to Teneligliptin
description: To assess change from baseline in glycated hemoglobin (HbA1c)
measure: Change in HbA1c
time frame: at 24, 52 weeks after switching to Teneligliptin
description: To assess change from baseline in HbA1c
measure: Change in FBG
time frame: at 12, 24, 52 weeks after switching to Teneligliptin
description: To assess change from baseline in fasting blood glucose (FBG)
measure: Change in body weight, BMI
time frame: at 12, 24, 52 weeks after switching to Teneligliptin
description: To assess change from baseline in body weight and body mass index (BMI)
measure: Change in lipid profile(Total cholesterol, LDL cholesterol, HDL cholesterol)
time frame: at 12, 24, 52 weeks after switching to Teneligliptin
description: To assess change from baseline in serum lipid profile (total cholesterol, LDL and HDL cholesterol, triglyceride)
measure: The percentage of patients with HbA1c <7.0% and <6.5%
time frame: at Weeks 12, 24, and 52 of teneligliptin treatment
description: To assess the percentage of patients with HbA1c <7.0% and <6.5%
measure: The percentage of patients with a decrease from baseline in HbA1c
time frame: at Weeks 12, 24, and 52 of teneligliptin treatment
description: To assess the percentage of patients with a decrease from baseline in HbA1c by ≥0.3% and ≥ 0.5%
measure: Safety Outcome
time frame: at Weeks 12, 24, and 52 of teneligliptin treatment
description: To assess the safety of teneligliptin treatment(AE, ADR, SAE etc.)
intervention type: Drug
intervention name: Teneligliptin 20mg
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
last name: Kwan Woo Lee, MD, Ph.D
role: Principal Investigator
affiliation: Ajou University School of Medicine
last name: Yeokyung Kim, CRM
phone: +82-2-527-5332
email: YeoKyeong.Kim@handok.com
last name: Yesung Jang, CRA
phone: +82-2-527-5383
email: yesung.Jang@handok.com
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No