<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/NCT01686711</url>
  </required_header>
  <id_info>
    <org_study_id>SYR-322-4833/CCT-901</org_study_id>
    <secondary_id>U1111-1132-3209</secondary_id>
    <secondary_id>JapicCTI-121916</secondary_id>
    <nct_id>NCT01686711</nct_id>
  </id_info>
  <brief_title>A Double-blind, Parallel Group, Comparative Study of Coadministration AD-4833 and SYR-322</brief_title>
  <official_title>A Phase 4, Multicenter, Randomized, Double-blind, Parallel-group, Comparative Study to Evaluate the Efficacy and Safety of AD-4833 When Orally Administered Once Daily as add-on to SYR-322 Versus SYR-322 Alone in the Treatment of Type 2 Diabetes Mellitus With Inadequate Glycemic Control Despite Treatment With SYR-322 in Addition to Diet and/or Exercise Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Takeda</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Takeda</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the efficacy and safety of coadministration AD-4833 and SYR-322 in patients with&#xD;
      diabetes mellitus.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
  </study_design_info>
  <primary_outcome>
    <measure>Glycosylated Hemoglobin (HbA1c)</measure>
    <time_frame>16 weeks</time_frame>
    <description>Measurement of change in HbA1c (ratio of hemoglobin bound to glucose)</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">207</enrollment>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>SYR-322 25 mg , AD-4833 15 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>SYR-322 25 mg , AD-4833 30 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>SYR-322 25 mg , AD-4833 placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AD-4833 15 mg</intervention_name>
    <arm_group_label>SYR-322 25 mg , AD-4833 15 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AD-4833 30 mg</intervention_name>
    <arm_group_label>SYR-322 25 mg , AD-4833 30 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>SYR-322 25 mg , AD-4833 placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Those judged to be capable of understanding and complying with protocol requirements&#xD;
             by the investigator or subinvestigator.&#xD;
&#xD;
          -  Those who can sign and date a written, informed consent form prior to the initiation&#xD;
             of any study procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those with concurrent serious cardiac disease, serious cerebrovascular disorder, or&#xD;
             serious pancreatic or hematological disease etc.&#xD;
&#xD;
          -  Others who are assessed to be ineligible for the study by the investigator or&#xD;
             subinvestigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Takeda (Note: This product was divested to Teijin Pharma Limited in 2023)</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Hirosaki-shi</city>
        <state>Aomori</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kisaratsu-shi</city>
        <state>Chiba</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Matsuyama-shi</city>
        <state>Ehime</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fukuoka-shi</city>
        <state>Fukuoka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kitakyushu-shi</city>
        <state>Fukuoka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kurume-shi</city>
        <state>Fukuoka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fukuyama-shi</city>
        <state>Hiroshima</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hiroshima-shi</city>
        <state>Hiroshima</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sapporo-shi</city>
        <state>Hokkaido</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Koga-shi</city>
        <state>Ibaraki</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Yokohama-shi</city>
        <state>Kanagawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kumamoto-shi</city>
        <state>Kumamoto</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Miyazaki-shi</city>
        <state>Miyazaki</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Suita-shi</city>
        <state>Osaka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Koshigaya-shi</city>
        <state>Saitama</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Otsu-shi</city>
        <state>Shiga</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chiyoda-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chuo-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Itabashi-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Meguro-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Minato-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ohta-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Shinjuku-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Toyama-shi</city>
        <state>Toyama</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Shimonoseki-shi</city>
        <state>Yamaguchi</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>August 31, 2012</study_first_submitted>
  <study_first_submitted_qc>September 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <last_update_submitted>August 29, 2023</last_update_submitted>
  <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2023</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>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pioglitazone</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/NCT01686711
org study id: SYR-322-4833/CCT-901
secondary id: U1111-1132-3209
secondary id: JapicCTI-121916
nct id: NCT01686711
lead sponsor: 
has dmc: No
To evaluate the efficacy and safety of coadministration AD-4833 and SYR-322 in patients with
      diabetes mellitus.
intervention model: Parallel Assignment
primary purpose: Treatment
measure: Glycosylated Hemoglobin (HbA1c)
time frame: 16 weeks
description: Measurement of change in HbA1c (ratio of hemoglobin bound to glucose)
arm group label: SYR-322 25 mg , AD-4833 15 mg
arm group type: Experimental
arm group label: SYR-322 25 mg , AD-4833 30 mg
arm group type: Experimental
arm group label: SYR-322 25 mg , AD-4833 placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: AD-4833 15 mg
arm group label: SYR-322 25 mg , AD-4833 15 mg
intervention type: Drug
intervention name: AD-4833 30 mg
arm group label: SYR-322 25 mg , AD-4833 30 mg
intervention type: Drug
intervention name: Placebo
arm group label: SYR-322 25 mg , AD-4833 placebo
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Study Director
role: Study Director
affiliation: Takeda (Note: This product was divested to Teijin Pharma Limited in 2023)
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Pioglitazone