<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/NCT02220907</url>
  </required_header>
  <id_info>
    <org_study_id>MT-2412-J01</org_study_id>
    <nct_id>NCT02220907</nct_id>
  </id_info>
  <brief_title>Long-Term Safety Study of MT-2412 in Japanese Patients With Type 2 Diabetes</brief_title>
  <official_title>Long-term Administration Study of MT-2412 in Patients With Type 2 Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mitsubishi Tanabe Pharma Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mitsubishi Tanabe Pharma Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety and efficacy of co-administration of&#xD;
      Teneligliptin (MP-513) and Canagliflozin (TA-7284) once daily for 52 weeks in Japanese&#xD;
      patients with Type 2 diabetes mellitus who are receiving treatment with Teneligliptin and&#xD;
      have inadequate glycemic control.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">February 2016</completion_date>
  <primary_completion_date type="Actual">February 2016</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Adverse Events</measure>
    <time_frame>52 Weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c)</measure>
    <time_frame>Baseline, 52 Weeks</time_frame>
    <description>The change from baseline in percentage of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 52.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Fasting Plasma Glucose Level</measure>
    <time_frame>Baseline, 52 Weeks</time_frame>
    <description>The change from baseline in fasting plasma glucose level collected at Week 52.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage Change in Body Weight From Baseline</measure>
    <time_frame>Baseline, 52 Weeks</time_frame>
    <description>The percentage change from baseline in body weight collected at Week 52.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">153</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Teneligliptin/Canagliflozin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive Teneligliptin and Canagliflozin once daily for 52 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Teneligliptin/Canagliflozin</intervention_name>
    <description>Co-administration of Teneligliptin and Canagliflozin orally once daily for 52 weeks.</description>
    <arm_group_label>Teneligliptin/Canagliflozin</arm_group_label>
    <other_name>Tenelia</other_name>
    <other_name>MP-513</other_name>
    <other_name>Canaglu</other_name>
    <other_name>TA-7284</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men or women age ≥20 years old&#xD;
&#xD;
          -  HbA1c of ≥7.0% and &lt;10.5%&#xD;
&#xD;
          -  FPG of ≤ 270 mg/dL&#xD;
&#xD;
          -  Patients who are under dietary management and taking therapeutic exercise for diabetes&#xD;
             over 12 weeks before treatment period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with type I diabetes, diabetes mellitus resulting from pancreatic disorder,&#xD;
             or secondary diabetes&#xD;
&#xD;
          -  Patients with serious diabetic complications&#xD;
&#xD;
          -  Patients with hereditary glucose-galactose malabsorption or primary renal glucosuria&#xD;
&#xD;
          -  Patients with Class III/IV heart failure symptoms according to New York Heart&#xD;
             Association (NYHA) functional classification&#xD;
&#xD;
          -  Patients with severe hepatic disorder or severe renal disorder.&#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>Takashi Kadowaki, MD</last_name>
    <role>Study Director</role>
    <affiliation>Tokyo University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nobuya Inagaki, MD</last_name>
    <role>Study Director</role>
    <affiliation>Kyoto University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kazuoki Kondo, MD</last_name>
    <role>Study Director</role>
    <affiliation>Mitsubishi Tanabe Pharma Corporation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research site</name>
      <address>
        <city>Chubu</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site</name>
      <address>
        <city>Chugoku</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site</name>
      <address>
        <city>Hokkaido</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site</name>
      <address>
        <city>Kanto</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site</name>
      <address>
        <city>Kyushu</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research site</name>
      <address>
        <city>Tohoku</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <results_reference>
    <citation>Kadowaki T, Inagaki N, Kondo K, Nishimura K, Kaneko G, Maruyama N, Nakanishi N, Watanabe Y, Gouda M, Iijima H. Long-term safety and efficacy of canagliflozin as add-on therapy to teneligliptin in Japanese patients with type 2 diabetes. Diabetes Obes Metab. 2018 Jan;20(1):77-84. doi: 10.1111/dom.13038. Epub 2017 Jul 31.</citation>
    <PMID>28608617</PMID>
  </results_reference>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>August 19, 2014</study_first_submitted>
  <study_first_submitted_qc>August 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <results_first_submitted>November 16, 2017</results_first_submitted>
  <results_first_submitted_qc>November 16, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">August 16, 2018</results_first_posted>
  <last_update_submitted>October 3, 2018</last_update_submitted>
  <last_update_submitted_qc>October 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>MT-2412</keyword>
  <keyword>MP-513</keyword>
  <keyword>TA-7284</keyword>
  <keyword>Teneligliptin</keyword>
  <keyword>Canagliflozin</keyword>
  <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>Canagliflozin</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Teneligliptin+Canagliflozin</title>
          <description>Teneligliptin and Canagliflozin once daily for 52 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="153"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="142"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Conflict with the stopping criteria</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Teneligliptin+Canagliflozin</title>
          <description>Teneligliptin and Canagliflozin once daily for 52 weeks.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="153"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="119"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="108"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Adverse Events</title>
        <time_frame>52 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Teneligliptin+Canagliflozin</title>
            <description>Teneligliptin and Canagliflozin once daily for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events</title>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="153"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Serious Adverse Event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adverse Event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="107"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c)</title>
        <description>The change from baseline in percentage of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 52.</description>
        <time_frame>Baseline, 52 Weeks</time_frame>
        <population>Full analysis set, last observation carried forward</population>
        <group_list>
          <group group_id="O1">
            <title>Teneligliptin+Canagliflozin</title>
            <description>Teneligliptin and Canagliflozin once daily for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c)</title>
          <description>The change from baseline in percentage of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 52.</description>
          <population>Full analysis set, last observation carried forward</population>
          <units>percentage of HbA1c</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="153"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.99" spread="0.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Fasting Plasma Glucose Level</title>
        <description>The change from baseline in fasting plasma glucose level collected at Week 52.</description>
        <time_frame>Baseline, 52 Weeks</time_frame>
        <population>Full analysis set, last observation carried forward. Outcome measure for one patient was not assessed at a certain timepoint due to dropout.</population>
        <group_list>
          <group group_id="O1">
            <title>Teneligliptin+Canagliflozin</title>
            <description>Teneligliptin and Canagliflozin once daily for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Fasting Plasma Glucose Level</title>
          <description>The change from baseline in fasting plasma glucose level collected at Week 52.</description>
          <population>Full analysis set, last observation carried forward. Outcome measure for one patient was not assessed at a certain timepoint due to dropout.</population>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="152"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-38.6" spread="29.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage Change in Body Weight From Baseline</title>
        <description>The percentage change from baseline in body weight collected at Week 52.</description>
        <time_frame>Baseline, 52 Weeks</time_frame>
        <population>Full analysis set, last observation carried forward. Outcome measure for one patient was not assessed at a certain timepoint due to dropout.</population>
        <group_list>
          <group group_id="O1">
            <title>Teneligliptin+Canagliflozin</title>
            <description>Teneligliptin and Canagliflozin once daily for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage Change in Body Weight From Baseline</title>
          <description>The percentage change from baseline in body weight collected at Week 52.</description>
          <population>Full analysis set, last observation carried forward. Outcome measure for one patient was not assessed at a certain timepoint due to dropout.</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="152"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.92" spread="3.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Teneligliptin+Canagliflozin</title>
          <description>Teneligliptin and Canagliflozin once daily for 52 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 18.1</default_vocab>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="153"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="153"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
              </event>
              <event>
                <sub_title>Sinus node dysfunction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="153"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
              </event>
              <event>
                <sub_title>Herpes zoster disseminated</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Ankle fracture</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="153"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Rectal cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
              </event>
              <event>
                <sub_title>Hepatocellular carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="153"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 18.1</default_vocab>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="61" subjects_at_risk="153"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="153"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="47" subjects_at_risk="153"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="153"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="153"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Trials, Information Desk</name_or_title>
      <organization>Mitsubishi Tanabe Pharma Corporation</organization>
      <email>cti-inq-ml@ml.mt-pharma.co.jp</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02220907
org study id: MT-2412-J01
nct id: NCT02220907
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the safety and efficacy of co-administration of
      Teneligliptin (MP-513) and Canagliflozin (TA-7284) once daily for 52 weeks in Japanese
      patients with Type 2 diabetes mellitus who are receiving treatment with Teneligliptin and
      have inadequate glycemic control.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With Adverse Events
time frame: 52 Weeks
measure: Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c)
time frame: Baseline, 52 Weeks
description: The change from baseline in percentage of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 52.
measure: Change From Baseline in Fasting Plasma Glucose Level
time frame: Baseline, 52 Weeks
description: The change from baseline in fasting plasma glucose level collected at Week 52.
measure: Percentage Change in Body Weight From Baseline
time frame: Baseline, 52 Weeks
description: The percentage change from baseline in body weight collected at Week 52.
arm group label: Teneligliptin/Canagliflozin
arm group type: Experimental
description: Patients receive Teneligliptin and Canagliflozin once daily for 52 weeks.
intervention type: Drug
intervention name: Teneligliptin/Canagliflozin
description: Co-administration of Teneligliptin and Canagliflozin orally once daily for 52 weeks.
arm group label: Teneligliptin/Canagliflozin
other name: Tenelia
other name: MP-513
other name: Canaglu
other name: TA-7284
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Takashi Kadowaki, MD
role: Study Director
affiliation: Tokyo University
last name: Nobuya Inagaki, MD
role: Study Director
affiliation: Kyoto University
last name: Kazuoki Kondo, MD
role: Study Director
affiliation: Mitsubishi Tanabe Pharma Corporation
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Japan
citation: Kadowaki T, Inagaki N, Kondo K, Nishimura K, Kaneko G, Maruyama N, Nakanishi N, Watanabe Y, Gouda M, Iijima H. Long-term safety and efficacy of canagliflozin as add-on therapy to teneligliptin in Japanese patients with type 2 diabetes. Diabetes Obes Metab. 2018 Jan;20(1):77-84. doi: 10.1111/dom.13038. Epub 2017 Jul 31.
PMID: 28608617
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Canagliflozin
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 