<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/NCT03770052</url>
  </required_header>
  <id_info>
    <org_study_id>Duvie2.5</org_study_id>
    <nct_id>NCT03770052</nct_id>
  </id_info>
  <brief_title>Glucose-Lowering Effects and Safety of Adding 0.25 or 0.5 mg Duvie</brief_title>
  <official_title>A Double Blind, Randomized, Investigator Initiated Study on Glucose-Lowering Effects and Safety of Adding 0.25 or 0.5 mg Duvie (Lobeglitazone) in Patients With Type 2 Diabetes With Inadequate Control on Metformin and DPP-4 Inhibitor Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pusan National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Chong Kun Dang Pharmaceutical Corp.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Pusan National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Glucose-Lowering Effects and Safety of Adding 0.25 or 0.5 mg Duvie&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a double blind, randomized, investigator initiated study on glucose-lowering&#xD;
      effects and Safety of Adding 0.25 or 0.5 mg Duvie (Lobeglitazone) in Patients With Type 2&#xD;
      Diabetes With Inadequate Control on Metformin and DPP-4 Inhibitor Therapy. The primary aim of&#xD;
      the study is to compared changes of HbA1c between 0.25mg robeblitazone add-on group and 0.5mg&#xD;
      robeglitazone add-on group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 24, 2018</start_date>
  <completion_date type="Actual">September 13, 2021</completion_date>
  <primary_completion_date type="Actual">August 19, 2021</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>HbA1c at 24 week</measure>
    <time_frame>24 week</time_frame>
    <description>changes of HbA1c between baseline and 24 week</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>HOMA-IR</measure>
    <time_frame>24 week</time_frame>
    <description>changes of HOMA-IR between baseline and 24 week</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>lipid levels</measure>
    <time_frame>24 week</time_frame>
    <description>changes of lipid levels between baseline and 24 week</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hs-CRP</measure>
    <time_frame>24 week</time_frame>
    <description>changes of hs-CRP between baseline and 24 week</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AST</measure>
    <time_frame>24 week</time_frame>
    <description>changes of AST between baseline and 24 week</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adiponectin</measure>
    <time_frame>24 week</time_frame>
    <description>changes of adiponectin between baseline and 24 week</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adverse event (weight gain,edema)</measure>
    <time_frame>24 week</time_frame>
    <description>changes of adverse event (weight gain,edema) between baseline and 24 week</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ALT</measure>
    <time_frame>24 week</time_frame>
    <description>changes of ALT between baseline and 24 week</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ALP</measure>
    <time_frame>24 week</time_frame>
    <description>changes of ALP between baseline and 24 week</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>total bilirubin</measure>
    <time_frame>24 week</time_frame>
    <description>changes of total bilirubin between baseline and 24 week</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">159</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <condition>Inadequate Glucose Control</condition>
  <arm_group>
    <arm_group_label>0.25mg robeglitazone add-on group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>0.25mg robeglitazone once daily in patients with type 2 diabetes with inadequate control on metformin and DPP-4 inhibitor therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>0.5mg robeglitazone add-on group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>0.5mg robeglitazone once daily in patients with type 2 diabetes with inadequate control on metformin and DPP-4 inhibitor therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>duvie</intervention_name>
    <description>take the intervention drug once daily according to the randomized groups</description>
    <arm_group_label>0.25mg robeglitazone add-on group</arm_group_label>
    <arm_group_label>0.5mg robeglitazone add-on group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Type Ⅱ diabetes mellitus&#xD;
&#xD;
          2. Between 19 years and 80 years old&#xD;
&#xD;
          3. BMI between 20kg/㎡ to 45kg/㎡&#xD;
&#xD;
          4. Among those using Metformin and DPP-4 inhibitor merging therapy for more than 3&#xD;
             months, A person who has not changed the dosage of Metformin 500 mg and DPP-4&#xD;
             inhibitor for more than 8 weeks at the time of screening&#xD;
&#xD;
          5. HbA1c 7.0 to 9.0&#xD;
&#xD;
          6. Agreement with written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Historical history of severe heart failure or heart failure (NYHA Class III&amp;IV)&#xD;
&#xD;
          2. Rapid coronary syndrome, cardiovascular interventions within 6 months&#xD;
&#xD;
          3. History of cerebral vascular diseases within six months&#xD;
&#xD;
          4. High blood pressure uncontrolled (&gt;160/100 mmHg)&#xD;
&#xD;
          5. In case weight loss drug is used within 3 months&#xD;
&#xD;
          6. In case of systemic corticosteroids treatment within 3 months&#xD;
&#xD;
          7. If there is an allergy or overreaction to the study drug or its components&#xD;
&#xD;
          8. In case of acute metabolic complications (ketonicemia or high osmotic pressure) within&#xD;
             6 months&#xD;
&#xD;
          9. Anemia Hb &lt; 12g/dL(male), 10g/dL(female)&#xD;
&#xD;
         10. Kidney function GFR &lt; 45mL/min/1.73m2 (GFR test results are calculated by the&#xD;
             Cockcroft-Gault Calculator).&#xD;
&#xD;
         11. impaired hepatic function (AST/ALT 2.5-fold the upper limit of the normal range [ULN])&#xD;
&#xD;
         12. TG&gt;500 mg/dL&#xD;
&#xD;
         13. LDL cholesterol &gt;160 mg/dL&#xD;
&#xD;
             - If a lipid-lowering agent is being taken, the existing dose should be taken during&#xD;
             the study period.&#xD;
&#xD;
         14. The thyroid hormone is within its normal range&#xD;
&#xD;
             - however, thyroid hormone may be registered at the discretion of the investigator&#xD;
             even if it is outside the normal range.&#xD;
&#xD;
         15. Laser treatment for proliferative retinopathy within 6 months&#xD;
&#xD;
         16. history of alcohol or drug abuse in the previous 3 months&#xD;
&#xD;
         17. history of most cancers not in remission for 5 years&#xD;
&#xD;
         18. Past history of bladder cancer&#xD;
&#xD;
         19. Women nursing or pregnant Persons who are not using effective contraceptive methods,&#xD;
             or who refuse to use contraceptives as specified below (permitted contraceptives:&#xD;
             condoms, castings, or implantation contraceptives, etc.) are installed with&#xD;
             contraceptives in the uterus&#xD;
&#xD;
         20. external injury, acute infections, a history/presence of any other severe disease, or&#xD;
             severe trauma&#xD;
&#xD;
         21. Patients who use basins - however, they can be registered by stopping 8 weeks before&#xD;
             the start of administration of medicines for clinical trials&#xD;
&#xD;
         22. A person who has used endemic insulin for more than 7 days in the last 8 weeks&#xD;
&#xD;
         23. A person with the drug usage in the TZD series over the last eight weeks.&#xD;
&#xD;
         24. When experiencing allergies, hypersensitivity, or side effects associated with drug&#xD;
             use in the TZD series;&#xD;
&#xD;
         25. The researcher determines that other participants may experience difficulties in&#xD;
             participating in the test through to the end, or that participation in the test may&#xD;
             result in additional risks or confusion in the test results.&#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>Pusan National University Hospital</name>
      <address>
        <city>Busan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 7, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>January 4, 2022</last_update_submitted>
  <last_update_submitted_qc>January 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pusan National University Hospital</investigator_affiliation>
    <investigator_full_name>In Ju Kim</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </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/NCT03770052
org study id: Duvie2.5
nct id: NCT03770052
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Glucose-Lowering Effects and Safety of Adding 0.25 or 0.5 mg Duvie
This study is a double blind, randomized, investigator initiated study on glucose-lowering
      effects and Safety of Adding 0.25 or 0.5 mg Duvie (Lobeglitazone) in Patients With Type 2
      Diabetes With Inadequate Control on Metformin and DPP-4 Inhibitor Therapy. The primary aim of
      the study is to compared changes of HbA1c between 0.25mg robeblitazone add-on group and 0.5mg
      robeglitazone add-on group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: HbA1c at 24 week
time frame: 24 week
description: changes of HbA1c between baseline and 24 week
measure: HOMA-IR
time frame: 24 week
description: changes of HOMA-IR between baseline and 24 week
measure: lipid levels
time frame: 24 week
description: changes of lipid levels between baseline and 24 week
measure: hs-CRP
time frame: 24 week
description: changes of hs-CRP between baseline and 24 week
measure: AST
time frame: 24 week
description: changes of AST between baseline and 24 week
measure: adiponectin
time frame: 24 week
description: changes of adiponectin between baseline and 24 week
measure: adverse event (weight gain,edema)
time frame: 24 week
description: changes of adverse event (weight gain,edema) between baseline and 24 week
measure: ALT
time frame: 24 week
description: changes of ALT between baseline and 24 week
measure: ALP
time frame: 24 week
description: changes of ALP between baseline and 24 week
measure: total bilirubin
time frame: 24 week
description: changes of total bilirubin between baseline and 24 week
arm group label: 0.25mg robeglitazone add-on group
arm group type: Experimental
description: 0.25mg robeglitazone once daily in patients with type 2 diabetes with inadequate control on metformin and DPP-4 inhibitor therapy
arm group label: 0.5mg robeglitazone add-on group
arm group type: Active Comparator
description: 0.5mg robeglitazone once daily in patients with type 2 diabetes with inadequate control on metformin and DPP-4 inhibitor therapy
intervention type: Drug
intervention name: duvie
description: take the intervention drug once daily according to the randomized groups
arm group label: 0.25mg robeglitazone add-on group
arm group label: 0.5mg robeglitazone add-on group
criteria: 
gender: All
minimum age: 19 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Pusan National University Hospital
investigator full name: In Ju Kim
investigator title: Professor
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No