<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/NCT04446026</url>
  </required_header>
  <id_info>
    <org_study_id>4-2020-0488</org_study_id>
    <nct_id>NCT04446026</nct_id>
  </id_info>
  <brief_title>A Randomized, Placebo-controlled Clinical Trial of Teneligliptin as Quadruple Oral Combination Therapy for Type 2 DM After Failure of an Oral Triple Anti-diabetic Regimen</brief_title>
  <official_title>A Randomized, Placebo-controlled Clinical Trial of Teneligliptin as Quadruple Oral Combination Therapy for Type 2 DM After Failure of an Oral Triple Anti-diabetic Regimen</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</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 is a randomized, placebo-controlled clinical trial of Teneligliptin as quadruple oral&#xD;
      combination therapy for type 2 diabetes after failure of an oral triple anti-diabetic&#xD;
      regimen. Patients with uncontrolled type 2 diabetes (7.1% ≤ HbA1c ≤ 9%) prescribed with&#xD;
      triple combination of oral antidiabetic drugs more than 12 weeks with sufficient doses&#xD;
      (metformin &gt;= 1000mg/d, Glimepiride &gt;=4 mg/day, Gliclazide &gt;= 60 mg/day, SGLT-2 inhibitor&#xD;
      with approved dose by Korea FDA) will be included. Using randomization, patients would take&#xD;
      either teneligliptin (20mg) or placebo for 12 weeks. After 12 weeks of trial, all patients&#xD;
      would receive teneligliptin for another 12 weeks. As outcomes, changes in HbA1c and fasting&#xD;
      plasma glucose at 12th and 24th weeks compared with at baseline, and proportions of patients&#xD;
      who achieved a glycemic goal (HbA1c &lt;=7%) at 12th and 24th weeks will be evaluated.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 8, 2020</start_date>
  <completion_date type="Actual">May 17, 2021</completion_date>
  <primary_completion_date type="Actual">December 7, 2020</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hb1Ac</measure>
    <time_frame>12 weeks</time_frame>
    <description>Difference between baseline and HbA1c at 12 weeks after treatment with test drug</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>HbA1c</measure>
    <time_frame>24 weeks</time_frame>
    <description>Difference between baseline and HbA1c at 24 weeks after treatment with test drug</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients who reached target blood glucose (6.5% or 7% as HbA1c)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Percentage of patients who reached target blood glucose (6.5% or 7% as HbA1c) at 12 and 24 weeks after treatment with the test drug</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients who reached target blood glucose (6.5% or 7% as HbA1c)</measure>
    <time_frame>24 weeks</time_frame>
    <description>Percentage of patients who reached target blood glucose (6.5% or 7% as HbA1c) at 12 and 24 weeks after treatment with the test drug</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting glucose</measure>
    <time_frame>12 weeks</time_frame>
    <description>Fasting blood glucose (FPG) at 12 and 24 weeks after treatment with test drug</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting glucose</measure>
    <time_frame>24 weeks</time_frame>
    <description>Fasting blood glucose (FPG) at 12 and 24 weeks after treatment with test drug</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>teneligliptin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>teneligliptin</intervention_name>
    <description>teneligliptin 20mg PO qd for 24weeks</description>
    <arm_group_label>teneligliptin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>teneligliptin 20mg PO qd for 12weeks after placebo 1T PO qd for 12 weeks</description>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age over 18 years and less than 81 years&#xD;
&#xD;
          2. Patients with type 2 diabetes prescribed with triple combination of oral antidiabetic&#xD;
             drugs more than 12 weeks with sufficient doses (metformin &gt;= 1000mg/d, Glimepiride &gt;=4&#xD;
             mg/day, Gliclazide &gt;= 60 mg/day, SGLT-2 inhibitor with approved dose by Korea FDA)&#xD;
&#xD;
          3. Uncontrolled hyperglycemia with 7.1% ≤ HbA1c ≤ 9% at randomization period&#xD;
&#xD;
          4. Recommended to use insulin by physicians&#xD;
&#xD;
          5. Patients able to understand study protocol and cooperative&#xD;
&#xD;
          6. Voluntary consent to participation of study after understanding study protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Type 1 diabetes, gestational diabetes, other than type 2 diabetes&#xD;
&#xD;
          2. Insulin treatment more than 1 week (not necessarily continuous use) prior to screening&#xD;
             visit within 1 year&#xD;
&#xD;
          3. Hypersensitivity to TENELIA tablet including main and other component&#xD;
&#xD;
          4. Use of DPP4 inhibitor more than 1 week prior to screening visit within 3 months or&#xD;
             discontinuation of DPP4 inhibitor due to severe side effects regardless of treatment&#xD;
             period&#xD;
&#xD;
          5. History of acute or chronic metabolic acidosis and ketosis including diabetic&#xD;
             ketoacidosis with/without comma prior to screening visit within 12 weeks&#xD;
&#xD;
          6. Genetic trait of galactose intolerance, Lapp lactase deficiency, or glucose-galactose&#xD;
             mal-absorption&#xD;
&#xD;
          7. Difficulty in oral ingestion of drug owing to anatomical abnormalities in head and&#xD;
             neck area, or owing to abnormalities in central nervous system&#xD;
&#xD;
          8. Steroid use including per oral and non-oral more than 14 consecutive days prior to&#xD;
             screening visit within 8 weeks (inhaled steroid use is permitted)&#xD;
&#xD;
          9. Histories of any malignancy prior to screening visit within 5 years&#xD;
&#xD;
         10. History of congestive heart failure (&gt;= 10) NYHA class III)&#xD;
&#xD;
         11. Uncontrolled arrhythmia, unstable angina, myocardial infarction, stroke, transient&#xD;
             ischemic attack, cerebrovascular disease prior to screening visit within 24 weeks&#xD;
&#xD;
         12. Initiation of statin to treat dyslipidemia prior to screening visit within 4 weeks or&#xD;
             anticipated increasing dose of statin during study period&#xD;
&#xD;
         13. Renal failure, chronic kidney disease stage &lt;=3 (estimated glomerular filtration rate&#xD;
             &lt;30 mL/min/1.73 m2, calculated using EKD-EPI) or patients with dialysis&#xD;
&#xD;
         14. Abnormalities in liver function test: AST, ALT, or ALP &gt;= 2.5 fold of ULN or patients&#xD;
             with liver cirrhosis (Child-Pugh class B or C)&#xD;
&#xD;
         15. Infection of HIV, HBV, or HCV and patients subjected to anti-viral therapy within 1&#xD;
             year&#xD;
&#xD;
         16. Pregnant or lactating women; or planning to be pregnant&#xD;
&#xD;
         17. Patients with other severe infection or with severe injuries, or patients expecting&#xD;
             any surgery with transient insulin use for peri-operational glucose control&#xD;
&#xD;
         18. Alcohol or any psychotropic substances dependancy , or dependency of any unapproved&#xD;
             substances&#xD;
&#xD;
         19. Last visit of other clinical trials for treatment purposes prior to screening visit&#xD;
             within 30 days&#xD;
&#xD;
         20. Other inappropriate properties judged by researchers&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Yonsei Severance 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>June 2021</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>June 7, 2021</last_update_submitted>
  <last_update_submitted_qc>June 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2021</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/NCT04446026
org study id: 4-2020-0488
nct id: NCT04446026
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a randomized, placebo-controlled clinical trial of Teneligliptin as quadruple oral
      combination therapy for type 2 diabetes after failure of an oral triple anti-diabetic
      regimen. Patients with uncontrolled type 2 diabetes (7.1% ≤ HbA1c ≤ 9%) prescribed with
      triple combination of oral antidiabetic drugs more than 12 weeks with sufficient doses
      (metformin >= 1000mg/d, Glimepiride >=4 mg/day, Gliclazide >= 60 mg/day, SGLT-2 inhibitor
      with approved dose by Korea FDA) will be included. Using randomization, patients would take
      either teneligliptin (20mg) or placebo for 12 weeks. After 12 weeks of trial, all patients
      would receive teneligliptin for another 12 weeks. As outcomes, changes in HbA1c and fasting
      plasma glucose at 12th and 24th weeks compared with at baseline, and proportions of patients
      who achieved a glycemic goal (HbA1c <=7%) at 12th and 24th weeks will be evaluated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Hb1Ac
time frame: 12 weeks
description: Difference between baseline and HbA1c at 12 weeks after treatment with test drug
measure: HbA1c
time frame: 24 weeks
description: Difference between baseline and HbA1c at 24 weeks after treatment with test drug
measure: Percentage of patients who reached target blood glucose (6.5% or 7% as HbA1c)
time frame: 12 weeks
description: Percentage of patients who reached target blood glucose (6.5% or 7% as HbA1c) at 12 and 24 weeks after treatment with the test drug
measure: Percentage of patients who reached target blood glucose (6.5% or 7% as HbA1c)
time frame: 24 weeks
description: Percentage of patients who reached target blood glucose (6.5% or 7% as HbA1c) at 12 and 24 weeks after treatment with the test drug
measure: Fasting glucose
time frame: 12 weeks
description: Fasting blood glucose (FPG) at 12 and 24 weeks after treatment with test drug
measure: Fasting glucose
time frame: 24 weeks
description: Fasting blood glucose (FPG) at 12 and 24 weeks after treatment with test drug
arm group label: teneligliptin
arm group type: Experimental
arm group label: placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: teneligliptin
description: teneligliptin 20mg PO qd for 24weeks
arm group label: teneligliptin
intervention type: Drug
intervention name: Placebo
description: teneligliptin 20mg PO qd for 12weeks after placebo 1T PO qd for 12 weeks
arm group label: placebo
criteria: 
gender: All
minimum age: 19 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No