<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/NCT02221284</url>
  </required_header>
  <id_info>
    <org_study_id>121-016</org_study_id>
    <secondary_id>JapicCTI-142609</secondary_id>
    <nct_id>NCT02221284</nct_id>
  </id_info>
  <brief_title>Alogliptin Tablets Specified Drug-use Survey &quot;Type 2 Diabetic Patients Receiving Combination Therapy With a Hypoglycemic Agent (e.g., Insulin Preparations or Rapid-acting Insulin Secretagogues)&quot;</brief_title>
  <official_title>Alogliptin (Nesina) Tablets Specified Drug-use Survey &quot;Type 2 Diabetes Mellitus: Combination Therapy With Hypoglycemic Drug (Insulin Preparation or Rapid-acting Insulin Secretagogues, Etc)&quot;</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this survey is to evaluate the safety and efficacy of long-term use of&#xD;
      alogliptin tablets (Nesina Tablets) in type 2 diabetic patients who have had an inadequate&#xD;
      response to hypoglycemic agents (e.g., insulin preparations or rapid-acting insulin&#xD;
      secretagogues)* in addition to dietary/exercise therapy. Participants will receive alogliptin&#xD;
      as part of routine medical care.&#xD;
&#xD;
      * Patients receiving these hypoglycemic agents (excluding α-glucosidase inhibitors,&#xD;
      thiazolidines, sulfonylureas, and biguanides) were excluded from existing specified drug-use&#xD;
      surveys for alogliptin tablets.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This survey was designed to evaluate the safety and efficacy of long-term use of alogliptin&#xD;
      tablets (Nesina Tablets) in type 2 diabetic patients who have had an inadequate response to&#xD;
      hypoglycemic agents (e.g., insulin preparations or rapid-acting insulin secretagogues) in&#xD;
      addition to dietary/exercise therapy. Participants will receive alogliptin as part of routine&#xD;
      medical care.&#xD;
&#xD;
      For adults, 25 mg of alogliptin is usually administered orally once daily.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 30, 2014</start_date>
  <completion_date type="Actual">June 30, 2017</completion_date>
  <primary_completion_date type="Actual">June 30, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Who Had One or More Adverse Reactions</measure>
    <time_frame>Up to Month 12</time_frame>
    <description>Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Glycosylated Hemoglobin (HbA1c)</measure>
    <time_frame>Baseline, and final assessment point (up to Month 12)</time_frame>
    <description>The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at final assessment point (up to Month 12) relative to baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Achieving Specified HbA1c Level (&lt; 7.0% and &lt;6.0%)</measure>
    <time_frame>Baseline, and final assessment point (up to Month 12)</time_frame>
    <description>The reported data were number of participants who achieved specified HbA1c Level (&lt; 7.0% and &lt;6.0%) during this study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Laboratory Test Values (Fasting Blood Glucose Level)</measure>
    <time_frame>Baseline, and final assessment point (up to Month 12)</time_frame>
    <description>The reported data were change from baseline in fasting blood glucose level.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Laboratory Test Values (Fasting Insulin Level)</measure>
    <time_frame>Baseline, and final assessment point (up to Month 12)</time_frame>
    <description>The reported data were change from baseline in fasting insulin level.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Laboratory Test Values (Homeostasis Model Assessment Ratio [HOMA-R])</measure>
    <time_frame>Baseline, and final assessment point (up to Month 12)</time_frame>
    <description>The reported data were change from baseline in HOMA-R. HOMA-R measures insulin resistance, calculated by fasting insulin (μU/mL) multiplied by fasting glucose (mg/dL), and divided by a constant (405). A higher score indicates higher insulin resistance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Laboratory Test Values (Homeostasis Model Assessment of Beta-cell Function [HOMA-β])</measure>
    <time_frame>Baseline, and final assessment point (up to Month 12)</time_frame>
    <description>The reported data were change from baseline in HOMA-β. HOMA-β measures as following; HOMA-β = fasting insulin (μU/mL) ×360/{fasting glucose (mg/dL) - 63}.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">964</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Alogliptin</arm_group_label>
    <description>Alogliptin 25 milligram (mg), tablets, orally, once daily, up to 12 months, along with an insulin preparations, with a rapid-acting insulin secretagogue (Glinide), with a SGLT-2 inhibitor, or the other diabetic drugs within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period in routine medical care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Alogliptin</intervention_name>
    <description>Alogliptin tablets</description>
    <arm_group_label>Alogliptin</arm_group_label>
    <other_name>Nesina Tablets</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Type 2 diabetes mellitus&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -Type 2 diabetic patients meeting the following criteria are included in this survey:&#xD;
&#xD;
        Patients who have had an inadequate response to the following medications/therapies:&#xD;
&#xD;
        • Use of one hypoglycemic agent such as insulin preparations and rapid-acting insulin&#xD;
        secretagogues, excluding other types of hypoglycemic agents (e.g., α-glucosidase&#xD;
        inhibitors, thiazolidines, sulfonylureas, and biguanides)*, in addition to dietary/exercise&#xD;
        therapy&#xD;
&#xD;
        * For use of alogliptin tablets in combination with these agents, a specified drug-use&#xD;
        survey is currently ongoing.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -Type 2 diabetic patients who meet any of the following criteria are excluded from this&#xD;
        survey: Patients with contraindications for alogliptin tablets&#xD;
&#xD;
          1. Those with severe ketosis, in a state of diabetic coma or precoma, or with type 1&#xD;
             diabetes mellitus [Quickly rectifying hyperglycemia with administration of intravenous&#xD;
             fluid or insulin is essential in these patients; therefore, administration of&#xD;
             alogliptin tablets is not appropriate.]&#xD;
&#xD;
          2. Those with severe infections, before or after surgery, or with serious trauma&#xD;
             [Controlling blood glucose with an injection of insulin is desirable for these&#xD;
             patients; therefore, administration of alogliptin tablets is not appropriate.]&#xD;
&#xD;
          3. Those with a history of hypersensitivity to any of the ingredients of alogliptin&#xD;
             tablets&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</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</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>August 18, 2014</study_first_submitted>
  <study_first_submitted_qc>August 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <results_first_submitted>June 26, 2018</results_first_submitted>
  <results_first_submitted_qc>May 14, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">July 19, 2019</results_first_posted>
  <last_update_submitted>October 24, 2019</last_update_submitted>
  <last_update_submitted_qc>October 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pharmacological therapy</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>Alogliptin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 2, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/84/NCT02221284/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 11, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/84/NCT02221284/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants took part in the study at 196 investigative sites in Japan, from 30 June 2014 to 30 June 2017. Data reports overall population, since data not collected separately per arm as specified in protocol.</recruitment_details>
      <pre_assignment_details>Enrolled participants had a diagnosis of type 2 diabetic mellitus and an inadequate response to hypoglycemic agents in addition to dietary/exercise therapy. Participants received interventions as part of routine medical care. Data reports overall population, since data not collected separately per arm as specified in protocol.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Overall Population</title>
          <description>Alogliptin 25 milligram (mg), tablets, orally, once daily, up to 12 months, along with an insulin preparations, with a rapid-acting insulin secretagogue (Glinide), with a SGLT-2 inhibitor, or the other diabetic drugs within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period in routine medical care.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="964"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="903"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="61"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Case Report Forms Uncollected</title>
              <participants_list>
                <participants group_id="P1" count="56"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Deviation</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety Analysis Set; The safety analysis set was defined as all participants who completed the study.</population>
      <group_list>
        <group group_id="B1">
          <title>Alogliptin + Insulin</title>
          <description>Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with insulin preparation within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.</description>
        </group>
        <group group_id="B2">
          <title>Alogliptin + Glinide</title>
          <description>Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with rapid-acting insulin secretagogue (Glinide) within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.</description>
        </group>
        <group group_id="B3">
          <title>Alogliptin + SGLT-2 Inhibitor</title>
          <description>Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with SGLT-2 inhibitor within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.</description>
        </group>
        <group group_id="B4">
          <title>Alogliptin + Other</title>
          <description>Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along without insulin preparations, glinide, or SGLT-2 inhibitor within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="573"/>
            <count group_id="B2" value="166"/>
            <count group_id="B3" value="102"/>
            <count group_id="B4" value="62"/>
            <count group_id="B5" value="903"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65.6" spread="12.27"/>
                    <measurement group_id="B2" value="67.9" spread="11.71"/>
                    <measurement group_id="B3" value="61.0" spread="13.72"/>
                    <measurement group_id="B4" value="61.2" spread="14.31"/>
                    <measurement group_id="B5" value="65.2" spread="12.65"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="257"/>
                    <measurement group_id="B2" value="67"/>
                    <measurement group_id="B3" value="35"/>
                    <measurement group_id="B4" value="26"/>
                    <measurement group_id="B5" value="385"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="316"/>
                    <measurement group_id="B2" value="99"/>
                    <measurement group_id="B3" value="67"/>
                    <measurement group_id="B4" value="36"/>
                    <measurement group_id="B5" value="518"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="0"/>
                    <count group_id="B5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Japan</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="573"/>
                    <measurement group_id="B2" value="166"/>
                    <measurement group_id="B3" value="102"/>
                    <measurement group_id="B4" value="62"/>
                    <measurement group_id="B5" value="903"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration of Diagnosis of Type-2 Diabetes Mellitus (Years)</title>
          <description>Mean duration between start of study and first time of diagnosis of type 2 diabetes mellitus was reported.</description>
          <population>The number analyzed is the number of participants with data available for analysis.</population>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="417"/>
                    <count group_id="B2" value="120"/>
                    <count group_id="B3" value="34"/>
                    <count group_id="B4" value="50"/>
                    <count group_id="B5" value="621"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14.24" spread="10.858"/>
                    <measurement group_id="B2" value="9.03" spread="9.058"/>
                    <measurement group_id="B3" value="6.57" spread="6.911"/>
                    <measurement group_id="B4" value="7.45" spread="6.831"/>
                    <measurement group_id="B5" value="12.26" spread="10.458"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <population>The number analyzed is the number of participants with data available for analysis.</population>
          <units>Centimeters (cm)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="523"/>
                    <count group_id="B2" value="155"/>
                    <count group_id="B3" value="75"/>
                    <count group_id="B4" value="50"/>
                    <count group_id="B5" value="803"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="160.0" spread="9.70"/>
                    <measurement group_id="B2" value="160.2" spread="10.12"/>
                    <measurement group_id="B3" value="164.3" spread="9.38"/>
                    <measurement group_id="B4" value="162.4" spread="9.02"/>
                    <measurement group_id="B5" value="160.6" spread="9.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <population>The number analyzed is the number of participants with data available for analysis.</population>
          <units>Kilograms (kg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="516"/>
                    <count group_id="B2" value="146"/>
                    <count group_id="B3" value="101"/>
                    <count group_id="B4" value="49"/>
                    <count group_id="B5" value="812"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62.57" spread="12.910"/>
                    <measurement group_id="B2" value="62.45" spread="13.141"/>
                    <measurement group_id="B3" value="72.37" spread="14.654"/>
                    <measurement group_id="B4" value="68.32" spread="14.248"/>
                    <measurement group_id="B5" value="64.11" spread="13.667"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <description>Body Mass Index = weight (kg)/[height (m)^2]</description>
          <population>The number analyzed is the number of participants with data available for analysis.</population>
          <units>kg/meter (m)^2</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="488"/>
                    <count group_id="B2" value="140"/>
                    <count group_id="B3" value="75"/>
                    <count group_id="B4" value="46"/>
                    <count group_id="B5" value="749"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.40" spread="4.037"/>
                    <measurement group_id="B2" value="24.22" spread="3.515"/>
                    <measurement group_id="B3" value="26.71" spread="4.380"/>
                    <measurement group_id="B4" value="25.90" spread="4.312"/>
                    <measurement group_id="B5" value="24.69" spread="4.065"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Waist Circumference (Male)</title>
          <population>This baseline characteristic was analyzed only in male participants.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>&lt; 85 cm</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="316"/>
                    <count group_id="B2" value="99"/>
                    <count group_id="B3" value="67"/>
                    <count group_id="B4" value="36"/>
                    <count group_id="B5" value="518"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;= 85 cm</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="316"/>
                    <count group_id="B2" value="99"/>
                    <count group_id="B3" value="67"/>
                    <count group_id="B4" value="36"/>
                    <count group_id="B5" value="518"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="316"/>
                    <count group_id="B2" value="99"/>
                    <count group_id="B3" value="67"/>
                    <count group_id="B4" value="36"/>
                    <count group_id="B5" value="518"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="279"/>
                    <measurement group_id="B2" value="70"/>
                    <measurement group_id="B3" value="56"/>
                    <measurement group_id="B4" value="30"/>
                    <measurement group_id="B5" value="435"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Waist Circumference (Female)</title>
          <population>This baseline characteristic was analyzed only in female participants.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>&lt; 90 cm</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="257"/>
                    <count group_id="B2" value="67"/>
                    <count group_id="B3" value="35"/>
                    <count group_id="B4" value="26"/>
                    <count group_id="B5" value="385"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;= 90 cm</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="257"/>
                    <count group_id="B2" value="67"/>
                    <count group_id="B3" value="35"/>
                    <count group_id="B4" value="26"/>
                    <count group_id="B5" value="385"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="257"/>
                    <count group_id="B2" value="67"/>
                    <count group_id="B3" value="35"/>
                    <count group_id="B4" value="26"/>
                    <count group_id="B5" value="385"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="217"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="31"/>
                    <measurement group_id="B4" value="24"/>
                    <measurement group_id="B5" value="323"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Healthcare Category</title>
          <description>Participants were categorized as outpatient and inpatient.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Outpatient</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="539"/>
                    <measurement group_id="B2" value="161"/>
                    <measurement group_id="B3" value="101"/>
                    <measurement group_id="B4" value="57"/>
                    <measurement group_id="B5" value="858"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Inpatient</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Medical Complications</title>
          <description>Complications defined as a disease or a health condition for each participant at the start of study. Complications were classified as congenital anomalies, endocrine disorders, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, gastrointestinal (GI) disorders, renal disease and other complications. Other complications included all complications except for those mentioned above.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Had No Medical Complications</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="69"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="21"/>
                    <measurement group_id="B4" value="14"/>
                    <measurement group_id="B5" value="122"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had Medical Complications</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="504"/>
                    <measurement group_id="B2" value="148"/>
                    <measurement group_id="B3" value="81"/>
                    <measurement group_id="B4" value="48"/>
                    <measurement group_id="B5" value="781"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Concomitant Diabetes Mellitus</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Had No Concomitant Diabetes Mellitus</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="324"/>
                    <measurement group_id="B2" value="123"/>
                    <measurement group_id="B3" value="65"/>
                    <measurement group_id="B4" value="44"/>
                    <measurement group_id="B5" value="556"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had Concomitant Diabetes Mellitus</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="249"/>
                    <measurement group_id="B2" value="43"/>
                    <measurement group_id="B3" value="37"/>
                    <measurement group_id="B4" value="18"/>
                    <measurement group_id="B5" value="347"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Concomitant Hypertension</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Had No Concomitant Hypertension</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="247"/>
                    <measurement group_id="B2" value="63"/>
                    <measurement group_id="B3" value="41"/>
                    <measurement group_id="B4" value="26"/>
                    <measurement group_id="B5" value="377"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had Concomitant Hypertension</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="326"/>
                    <measurement group_id="B2" value="103"/>
                    <measurement group_id="B3" value="61"/>
                    <measurement group_id="B4" value="36"/>
                    <measurement group_id="B5" value="526"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Concomitant Hyperlipidemia</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Had No Concomitant Hyperlipidemia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="261"/>
                    <measurement group_id="B2" value="68"/>
                    <measurement group_id="B3" value="38"/>
                    <measurement group_id="B4" value="29"/>
                    <measurement group_id="B5" value="396"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had Concomitant Hyperlipidemia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="312"/>
                    <measurement group_id="B2" value="98"/>
                    <measurement group_id="B3" value="64"/>
                    <measurement group_id="B4" value="33"/>
                    <measurement group_id="B5" value="507"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Concomitant Hyperuricaemia</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Had No Concomitant Hyperuricaemia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="522"/>
                    <measurement group_id="B2" value="145"/>
                    <measurement group_id="B3" value="93"/>
                    <measurement group_id="B4" value="60"/>
                    <measurement group_id="B5" value="820"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had Concomitant Hyperuricaemia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Concomitant Hepatic Disorder</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Had No Concomitant Hepatic Disorder</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="467"/>
                    <measurement group_id="B2" value="147"/>
                    <measurement group_id="B3" value="84"/>
                    <measurement group_id="B4" value="51"/>
                    <measurement group_id="B5" value="749"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had Concomitant Hepatic Disorder</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="106"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="11"/>
                    <measurement group_id="B5" value="154"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Degree of Hepatic Dysfunction</title>
          <description>Severity was determined using aspartate aminotransferase (AST) or alanine transaminase (ALT) values at the start of treatment with alogliptin. For the assessment of severity, the following categories were used and higher grades of serum AST or ALT were adopted. Normal: &lt;50 units per liter (U/L) Grade 1: &gt;=50 to &lt;100 U/L Grade 2: &gt;=100 to &lt;500 U/L Grade 3: &gt;=500 U/L</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Normal</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="404"/>
                    <measurement group_id="B2" value="94"/>
                    <measurement group_id="B3" value="63"/>
                    <measurement group_id="B4" value="36"/>
                    <measurement group_id="B5" value="597"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="140"/>
                    <measurement group_id="B2" value="62"/>
                    <measurement group_id="B3" value="29"/>
                    <measurement group_id="B4" value="21"/>
                    <measurement group_id="B5" value="252"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Concomitant Renal Disorder</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Had No Concomitant Renal Disorder</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="412"/>
                    <measurement group_id="B2" value="139"/>
                    <measurement group_id="B3" value="73"/>
                    <measurement group_id="B4" value="49"/>
                    <measurement group_id="B5" value="673"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had Concomitant Renal Disorder</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="161"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="29"/>
                    <measurement group_id="B4" value="13"/>
                    <measurement group_id="B5" value="230"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Degree of Renal Dysfunction (eGFR)</title>
          <description>Estimated glomerular filtration rate (eGFR) was calculated using variables of gender, age at the start of treatment, and serum creatinine values, and severity was determined based on the following categories. If the serum creatinine value or age at the start of treatment was not listed, the severity was reported as &quot;unknown&quot;. Normal: &gt;=90 milliliter per min (mL/min)/1.73^2, Mild: &gt;=60 mL/min/1.73^2 to &lt;90 mL/min/1.73^2, Moderate: &gt;=30 mL/min/1.73^2 to &lt;60 mL/min/1.73^2, Severe: &lt;30 mL/min/1.73^2; eGFR= 194 * Cr^-1.094 * (age)^-0.287 (* 0.739 if female) where Cr is creatinine value.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Normal</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="85"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="23"/>
                    <measurement group_id="B4" value="16"/>
                    <measurement group_id="B5" value="154"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mild</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="235"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="38"/>
                    <measurement group_id="B4" value="22"/>
                    <measurement group_id="B5" value="333"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="118"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="168"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Normal or Mild</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="320"/>
                    <measurement group_id="B2" value="68"/>
                    <measurement group_id="B3" value="61"/>
                    <measurement group_id="B4" value="38"/>
                    <measurement group_id="B5" value="487"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate or Severe</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="130"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="181"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="123"/>
                    <measurement group_id="B2" value="69"/>
                    <measurement group_id="B3" value="23"/>
                    <measurement group_id="B4" value="20"/>
                    <measurement group_id="B5" value="235"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Degree of Renal Dysfunction (Cr)</title>
          <description>Normal or Mild: =&lt; 1.4 mg/dL (for male) or =&lt; 1.2 mg/dL (for female), Moderate: &gt;1.4 mg/dL to =&lt; 2.4 mg/dL (for male) or &gt;1.2 mg/dL to =&lt; 2.0 mg/dL (for female), Severe: &gt; 2.4 mg/dL (for male), &gt; 2.0 mg/dL (for female). If the serum creatinine value (Cr) at the start of treatment was not listed, the severity was reported as &quot;unknown&quot;.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Normal or Mild</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="431"/>
                    <measurement group_id="B2" value="94"/>
                    <measurement group_id="B3" value="78"/>
                    <measurement group_id="B4" value="42"/>
                    <measurement group_id="B5" value="645"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate or Severe</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="123"/>
                    <measurement group_id="B2" value="69"/>
                    <measurement group_id="B3" value="23"/>
                    <measurement group_id="B4" value="20"/>
                    <measurement group_id="B5" value="235"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Concomitant Cardiac Disease</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Had No Concomitant Cardiac Disease</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="467"/>
                    <measurement group_id="B2" value="154"/>
                    <measurement group_id="B3" value="96"/>
                    <measurement group_id="B4" value="54"/>
                    <measurement group_id="B5" value="771"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had Concomitant Cardiac Disease</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="106"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="132"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Concomitant Heart Failure</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Had No Concomitant Heart Failure</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="546"/>
                    <measurement group_id="B2" value="166"/>
                    <measurement group_id="B3" value="101"/>
                    <measurement group_id="B4" value="61"/>
                    <measurement group_id="B5" value="874"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had Concomitant Heart Failure</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>New York Heart Association (NYHA) Heart Failure Classification</title>
          <description>NYHA functional classification ranges from Class I (participants with cardiac disease but without resulting limitations of physical activity), Class II (participants with cardiac disease resulting in slight limitation of physical activity), Class III (participants with cardiac disease resulting in marked limitation of physical activity), Class IV (participants with cardiac disease resulting in inability to carry on any physical activity without discomfort).</description>
          <population>This baseline characteristic was analyzed only for participants who had complications of heart failure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Class I</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="27"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="1"/>
                    <count group_id="B4" value="1"/>
                    <count group_id="B5" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Class II</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="27"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="1"/>
                    <count group_id="B4" value="1"/>
                    <count group_id="B5" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="27"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="1"/>
                    <count group_id="B4" value="1"/>
                    <count group_id="B5" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Concomitant Stroke-Related Disease</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Had No Concomitant Stroke-Related Disease</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="520"/>
                    <measurement group_id="B2" value="157"/>
                    <measurement group_id="B3" value="99"/>
                    <measurement group_id="B4" value="61"/>
                    <measurement group_id="B5" value="837"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had Concomitant Stroke-Related Disease</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Concomitant Allergic Condition</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Had No Concomitant Allergic Condition</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="553"/>
                    <measurement group_id="B2" value="161"/>
                    <measurement group_id="B3" value="99"/>
                    <measurement group_id="B4" value="59"/>
                    <measurement group_id="B5" value="872"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had Concomitant Allergic Condition</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Concomitant Malignant Tumor</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Had No Concomitant Malignant Tumor</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="548"/>
                    <measurement group_id="B2" value="160"/>
                    <measurement group_id="B3" value="102"/>
                    <measurement group_id="B4" value="59"/>
                    <measurement group_id="B5" value="869"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had Concomitant Malignant Tumor</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Medical History</title>
          <description>Medical history defined as a disease or a health condition for each participant before start of the study. Medical history was classified as congenital anomalies, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, GI disorders, hepatic and biliary disorders, renal disease and other medical history. Other medical history included all medical history except for those mentioned above.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Had No Medical History</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="411"/>
                    <measurement group_id="B2" value="123"/>
                    <measurement group_id="B3" value="95"/>
                    <measurement group_id="B4" value="47"/>
                    <measurement group_id="B5" value="676"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had Medical History</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="125"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="12"/>
                    <measurement group_id="B5" value="170"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Predisposition to Hypersensitivity</title>
          <description>The baseline characteristic was analyzed in participants who had a liability or tendency to suffer from hypersensitivity.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Had No Predisposition to Hypersensitivity</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="508"/>
                    <measurement group_id="B2" value="141"/>
                    <measurement group_id="B3" value="98"/>
                    <measurement group_id="B4" value="56"/>
                    <measurement group_id="B5" value="803"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had Predisposition to Hypersensitivity</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Drinking Habits</title>
          <description>Participants who answered Yes or No for a question &quot;Drink Alcohol Almost Every Day?&quot; were reported.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Yes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="110"/>
                    <measurement group_id="B2" value="49"/>
                    <measurement group_id="B3" value="23"/>
                    <measurement group_id="B4" value="14"/>
                    <measurement group_id="B5" value="196"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="377"/>
                    <measurement group_id="B2" value="92"/>
                    <measurement group_id="B3" value="57"/>
                    <measurement group_id="B4" value="39"/>
                    <measurement group_id="B5" value="565"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="86"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="22"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="142"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Smoking Classification</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Never Smoked</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="289"/>
                    <measurement group_id="B2" value="65"/>
                    <measurement group_id="B3" value="43"/>
                    <measurement group_id="B4" value="25"/>
                    <measurement group_id="B5" value="422"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Current Smoker</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="16"/>
                    <measurement group_id="B5" value="126"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ex-Smoker</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="103"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="19"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="177"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="573"/>
                    <count group_id="B2" value="166"/>
                    <count group_id="B3" value="102"/>
                    <count group_id="B4" value="62"/>
                    <count group_id="B5" value="903"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="117"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="25"/>
                    <measurement group_id="B4" value="11"/>
                    <measurement group_id="B5" value="178"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hemoglobin A1c (HbA1c)</title>
          <population>The number analyzed is the number of participants with data available for analysis.</population>
          <units>Percent</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="559"/>
                    <count group_id="B2" value="160"/>
                    <count group_id="B3" value="96"/>
                    <count group_id="B4" value="61"/>
                    <count group_id="B5" value="876"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.44" spread="1.662"/>
                    <measurement group_id="B2" value="7.60" spread="1.051"/>
                    <measurement group_id="B3" value="7.66" spread="1.379"/>
                    <measurement group_id="B4" value="8.78" spread="2.053"/>
                    <measurement group_id="B5" value="8.21" spread="1.612"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Had One or More Adverse Reactions</title>
        <description>Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.</description>
        <time_frame>Up to Month 12</time_frame>
        <population>Safety Analysis Set; The safety analysis set was defined as all participants who completed the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Alogliptin + Insulin</title>
            <description>Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with insulin preparation within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.</description>
          </group>
          <group group_id="O2">
            <title>Alogliptin + Glinide</title>
            <description>Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with rapid-acting insulin secretagogue (Glinide) within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.</description>
          </group>
          <group group_id="O3">
            <title>Alogliptin + SGLT-2 Inhibitor</title>
            <description>Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with SGLT-2 inhibitor within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.</description>
          </group>
          <group group_id="O4">
            <title>Alogliptin + Other</title>
            <description>Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along without insulin preparations, glinide, or SGLT-2 inhibitor within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Had One or More Adverse Reactions</title>
          <description>Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.</description>
          <population>Safety Analysis Set; The safety analysis set was defined as all participants who completed the study.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="573"/>
                <count group_id="O2" value="166"/>
                <count group_id="O3" value="102"/>
                <count group_id="O4" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.41"/>
                    <measurement group_id="O2" value="1.20"/>
                    <measurement group_id="O3" value="0.98"/>
                    <measurement group_id="O4" value="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Glycosylated Hemoglobin (HbA1c)</title>
        <description>The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at final assessment point (up to Month 12) relative to baseline.</description>
        <time_frame>Baseline, and final assessment point (up to Month 12)</time_frame>
        <population>Efficacy assessment population was defined as participants who completed study and had available efficacy data at baseline and post baseline. Efficacy analysis was planned to be assessed in Alogliptin + Insulin, Alogliptin + Glinide and Alogliptin + SGLT-2 inhibitor groups and data for Alogliptin + Other were not collected as specified in protocol.</population>
        <group_list>
          <group group_id="O1">
            <title>Alogliptin + Insulin</title>
            <description>Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with insulin preparation within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.</description>
          </group>
          <group group_id="O2">
            <title>Alogliptin + Glinide</title>
            <description>Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with rapid-acting insulin secretagogue (Glinide) within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.</description>
          </group>
          <group group_id="O3">
            <title>Alogliptin + SGLT-2 Inhibitor</title>
            <description>Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with SGLT-2 inhibitor within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Glycosylated Hemoglobin (HbA1c)</title>
          <description>The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at final assessment point (up to Month 12) relative to baseline.</description>
          <population>Efficacy assessment population was defined as participants who completed study and had available efficacy data at baseline and post baseline. Efficacy analysis was planned to be assessed in Alogliptin + Insulin, Alogliptin + Glinide and Alogliptin + SGLT-2 inhibitor groups and data for Alogliptin + Other were not collected as specified in protocol.</population>
          <units>Percent</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="546"/>
                <count group_id="O2" value="158"/>
                <count group_id="O3" value="96"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.66" spread="1.622"/>
                    <measurement group_id="O2" value="-0.49" spread="0.940"/>
                    <measurement group_id="O3" value="-0.60" spread="1.102"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Achieving Specified HbA1c Level (&lt; 7.0% and &lt;6.0%)</title>
        <description>The reported data were number of participants who achieved specified HbA1c Level (&lt; 7.0% and &lt;6.0%) during this study.</description>
        <time_frame>Baseline, and final assessment point (up to Month 12)</time_frame>
        <population>Efficacy assessment population was defined as participants who completed study and had available efficacy data at baseline and post baseline. Efficacy analysis was planned to be assessed in Alogliptin + Insulin, Alogliptin + Glinide and Alogliptin + SGLT-2 inhibitor groups and data for Alogliptin + Other were not collected as specified in protocol.</population>
        <group_list>
          <group group_id="O1">
            <title>Alogliptin + Insulin</title>
            <description>Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with insulin preparation within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.</description>
          </group>
          <group group_id="O2">
            <title>Alogliptin + Glinide</title>
            <description>Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with rapid-acting insulin secretagogue (Glinide) within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.</description>
          </group>
          <group group_id="O3">
            <title>Alogliptin + SGLT-2 Inhibitor</title>
            <description>Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with SGLT-2 inhibitor within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Achieving Specified HbA1c Level (&lt; 7.0% and &lt;6.0%)</title>
          <description>The reported data were number of participants who achieved specified HbA1c Level (&lt; 7.0% and &lt;6.0%) during this study.</description>
          <population>Efficacy assessment population was defined as participants who completed study and had available efficacy data at baseline and post baseline. Efficacy analysis was planned to be assessed in Alogliptin + Insulin, Alogliptin + Glinide and Alogliptin + SGLT-2 inhibitor groups and data for Alogliptin + Other were not collected as specified in protocol.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="557"/>
                <count group_id="O2" value="162"/>
                <count group_id="O3" value="101"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>HbA1c Level &lt; 7.0%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="161"/>
                    <measurement group_id="O2" value="87"/>
                    <measurement group_id="O3" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HbA1c Level &lt; 6.0%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Laboratory Test Values (Fasting Blood Glucose Level)</title>
        <description>The reported data were change from baseline in fasting blood glucose level.</description>
        <time_frame>Baseline, and final assessment point (up to Month 12)</time_frame>
        <population>Efficacy assessment population was defined as participants who completed study and had available efficacy data at baseline and post baseline. Efficacy analysis was planned to be assessed in Alogliptin + Insulin, Alogliptin + Glinide and Alogliptin + SGLT-2 inhibitor groups and data for Alogliptin + Other were not collected as specified in protocol.</population>
        <group_list>
          <group group_id="O1">
            <title>Alogliptin + Insulin</title>
            <description>Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with insulin preparation within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.</description>
          </group>
          <group group_id="O2">
            <title>Alogliptin + Glinide</title>
            <description>Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with rapid-acting insulin secretagogue (Glinide) within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.</description>
          </group>
          <group group_id="O3">
            <title>Alogliptin + SGLT-2 Inhibitor</title>
            <description>Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with SGLT-2 inhibitor within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Laboratory Test Values (Fasting Blood Glucose Level)</title>
          <description>The reported data were change from baseline in fasting blood glucose level.</description>
          <population>Efficacy assessment population was defined as participants who completed study and had available efficacy data at baseline and post baseline. Efficacy analysis was planned to be assessed in Alogliptin + Insulin, Alogliptin + Glinide and Alogliptin + SGLT-2 inhibitor groups and data for Alogliptin + Other were not collected as specified in protocol.</population>
          <units>Milligram (mg)/deciliter (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="87"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-16.4" spread="65.96"/>
                    <measurement group_id="O2" value="-32.0" spread="42.00"/>
                    <measurement group_id="O3" value="-18.7" spread="35.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Laboratory Test Values (Fasting Insulin Level)</title>
        <description>The reported data were change from baseline in fasting insulin level.</description>
        <time_frame>Baseline, and final assessment point (up to Month 12)</time_frame>
        <population>Efficacy assessment population was defined as participants who completed study and had available efficacy data at baseline and post baseline. Efficacy analysis was planned to be assessed in Alogliptin + Insulin, Alogliptin + Glinide and Alogliptin + SGLT-2 inhibitor groups and data for Alogliptin + Other were not collected as specified in protocol.</population>
        <group_list>
          <group group_id="O1">
            <title>Alogliptin + Insulin</title>
            <description>Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with insulin preparation within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.</description>
          </group>
          <group group_id="O2">
            <title>Alogliptin + Glinide</title>
            <description>Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with rapid-acting insulin secretagogue (Glinide) within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.</description>
          </group>
          <group group_id="O3">
            <title>Alogliptin + SGLT-2 Inhibitor</title>
            <description>Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with SGLT-2 inhibitor within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Laboratory Test Values (Fasting Insulin Level)</title>
          <description>The reported data were change from baseline in fasting insulin level.</description>
          <population>Efficacy assessment population was defined as participants who completed study and had available efficacy data at baseline and post baseline. Efficacy analysis was planned to be assessed in Alogliptin + Insulin, Alogliptin + Glinide and Alogliptin + SGLT-2 inhibitor groups and data for Alogliptin + Other were not collected as specified in protocol.</population>
          <units>Micro Units per Milliliter (μU/mL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.08" spread="3.414"/>
                    <measurement group_id="O2" value="2.26" spread="4.948"/>
                    <measurement group_id="O3" value="0.40" spread="NA">Standard Deviation was not calculated as only one participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Laboratory Test Values (Homeostasis Model Assessment Ratio [HOMA-R])</title>
        <description>The reported data were change from baseline in HOMA-R. HOMA-R measures insulin resistance, calculated by fasting insulin (μU/mL) multiplied by fasting glucose (mg/dL), and divided by a constant (405). A higher score indicates higher insulin resistance.</description>
        <time_frame>Baseline, and final assessment point (up to Month 12)</time_frame>
        <population>Efficacy assessment population was defined as participants who completed study and had available efficacy data at baseline and post baseline. Efficacy analysis was planned to be assessed in Alogliptin + Insulin, Alogliptin + Glinide and Alogliptin + SGLT-2 inhibitor groups and data for Alogliptin + Other were not collected as specified in protocol.</population>
        <group_list>
          <group group_id="O1">
            <title>Alogliptin + Insulin</title>
            <description>Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with insulin preparation within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.</description>
          </group>
          <group group_id="O2">
            <title>Alogliptin + Glinide</title>
            <description>Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with rapid-acting insulin secretagogue (Glinide) within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.</description>
          </group>
          <group group_id="O3">
            <title>Alogliptin + SGLT-2 Inhibitor</title>
            <description>Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with SGLT-2 inhibitor within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Laboratory Test Values (Homeostasis Model Assessment Ratio [HOMA-R])</title>
          <description>The reported data were change from baseline in HOMA-R. HOMA-R measures insulin resistance, calculated by fasting insulin (μU/mL) multiplied by fasting glucose (mg/dL), and divided by a constant (405). A higher score indicates higher insulin resistance.</description>
          <population>Efficacy assessment population was defined as participants who completed study and had available efficacy data at baseline and post baseline. Efficacy analysis was planned to be assessed in Alogliptin + Insulin, Alogliptin + Glinide and Alogliptin + SGLT-2 inhibitor groups and data for Alogliptin + Other were not collected as specified in protocol.</population>
          <units>HOMA-R Score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.58" spread="2.170"/>
                    <measurement group_id="O2" value="-0.25" spread="2.094"/>
                    <measurement group_id="O3" value="0.00" spread="NA">Standard Deviation was not calculated as only one participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Laboratory Test Values (Homeostasis Model Assessment of Beta-cell Function [HOMA-β])</title>
        <description>The reported data were change from baseline in HOMA-β. HOMA-β measures as following; HOMA-β = fasting insulin (μU/mL) ×360/{fasting glucose (mg/dL) - 63}.</description>
        <time_frame>Baseline, and final assessment point (up to Month 12)</time_frame>
        <population>Efficacy assessment population was defined as participants who completed study and had available efficacy data at baseline and post baseline. Efficacy analysis was planned to be assessed in Alogliptin + Insulin, Alogliptin + Glinide and Alogliptin + SGLT-2 inhibitor groups and data for Alogliptin + Other were not collected as specified in protocol.</population>
        <group_list>
          <group group_id="O1">
            <title>Alogliptin + Insulin</title>
            <description>Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with insulin preparation within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.</description>
          </group>
          <group group_id="O2">
            <title>Alogliptin + Glinide</title>
            <description>Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with rapid-acting insulin secretagogue (Glinide) within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.</description>
          </group>
          <group group_id="O3">
            <title>Alogliptin + SGLT-2 Inhibitor</title>
            <description>Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with SGLT-2 inhibitor within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Laboratory Test Values (Homeostasis Model Assessment of Beta-cell Function [HOMA-β])</title>
          <description>The reported data were change from baseline in HOMA-β. HOMA-β measures as following; HOMA-β = fasting insulin (μU/mL) ×360/{fasting glucose (mg/dL) - 63}.</description>
          <population>Efficacy assessment population was defined as participants who completed study and had available efficacy data at baseline and post baseline. Efficacy analysis was planned to be assessed in Alogliptin + Insulin, Alogliptin + Glinide and Alogliptin + SGLT-2 inhibitor groups and data for Alogliptin + Other were not collected as specified in protocol.</population>
          <units>Percentage of beta cell function</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.32" spread="17.286"/>
                    <measurement group_id="O2" value="33.38" spread="19.851"/>
                    <measurement group_id="O3" value="15.40" spread="NA">Standard Deviation was not calculated as only one participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to Month 12</time_frame>
      <desc>At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here. ADRs are adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment.</desc>
      <group_list>
        <group group_id="E1">
          <title>Alogliptin + Insulin</title>
          <description>Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with insulin preparation within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.</description>
        </group>
        <group group_id="E2">
          <title>Alogliptin + Glinide</title>
          <description>Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with rapid-acting insulin secretagogue (Glinide) within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.</description>
        </group>
        <group group_id="E3">
          <title>Alogliptin + SGLT-2 Inhibit</title>
          <description>Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along with SGLT-2 inhibitor within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.</description>
        </group>
        <group group_id="E4">
          <title>Alogliptin + Other</title>
          <description>Alogliptin 25 mg, tablets, orally, once daily for up to 12 months, along without insulin preparations, glinide, or SGLT-2 inhibitor within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period. Participants received interventions as part of routine medical care.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA Ver.20.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="573"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="166"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="573"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="166"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac failure acut</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="573"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="166"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Cardio-respiratory arrest</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="573"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="166"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Death</sub_title>
                <description>The reasons of events are not determined because assessment findings were insufficient to specify the reason.</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="573"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="166"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1.0</frequency_threshold>
        <default_vocab>MedDRA Ver.20.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="573"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="166"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="573"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="166"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="573"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="166"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="62"/>
              </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>
      <restrictive_agreement>The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Director</name_or_title>
      <organization>Takeda</organization>
      <phone>+1-877-825-3327</phone>
      <email>trialdisclosures@takeda.com</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/NCT02221284
org study id: 121-016
secondary id: JapicCTI-142609
nct id: NCT02221284
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this survey is to evaluate the safety and efficacy of long-term use of
      alogliptin tablets (Nesina Tablets) in type 2 diabetic patients who have had an inadequate
      response to hypoglycemic agents (e.g., insulin preparations or rapid-acting insulin
      secretagogues)* in addition to dietary/exercise therapy. Participants will receive alogliptin
      as part of routine medical care.

      * Patients receiving these hypoglycemic agents (excluding α-glucosidase inhibitors,
      thiazolidines, sulfonylureas, and biguanides) were excluded from existing specified drug-use
      surveys for alogliptin tablets.
This survey was designed to evaluate the safety and efficacy of long-term use of alogliptin
      tablets (Nesina Tablets) in type 2 diabetic patients who have had an inadequate response to
      hypoglycemic agents (e.g., insulin preparations or rapid-acting insulin secretagogues) in
      addition to dietary/exercise therapy. Participants will receive alogliptin as part of routine
      medical care.

      For adults, 25 mg of alogliptin is usually administered orally once daily.
observational model: Cohort
time perspective: Prospective
measure: Percentage of Participants Who Had One or More Adverse Reactions
time frame: Up to Month 12
description: Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.
measure: Change From Baseline in Glycosylated Hemoglobin (HbA1c)
time frame: Baseline, and final assessment point (up to Month 12)
description: The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at final assessment point (up to Month 12) relative to baseline.
measure: Number of Participants Achieving Specified HbA1c Level (< 7.0% and <6.0%)
time frame: Baseline, and final assessment point (up to Month 12)
description: The reported data were number of participants who achieved specified HbA1c Level (< 7.0% and <6.0%) during this study.
measure: Change From Baseline in Laboratory Test Values (Fasting Blood Glucose Level)
time frame: Baseline, and final assessment point (up to Month 12)
description: The reported data were change from baseline in fasting blood glucose level.
measure: Change From Baseline in Laboratory Test Values (Fasting Insulin Level)
time frame: Baseline, and final assessment point (up to Month 12)
description: The reported data were change from baseline in fasting insulin level.
measure: Change From Baseline in Laboratory Test Values (Homeostasis Model Assessment Ratio [HOMA-R])
time frame: Baseline, and final assessment point (up to Month 12)
description: The reported data were change from baseline in HOMA-R. HOMA-R measures insulin resistance, calculated by fasting insulin (μU/mL) multiplied by fasting glucose (mg/dL), and divided by a constant (405). A higher score indicates higher insulin resistance.
measure: Change From Baseline in Laboratory Test Values (Homeostasis Model Assessment of Beta-cell Function [HOMA-β])
time frame: Baseline, and final assessment point (up to Month 12)
description: The reported data were change from baseline in HOMA-β. HOMA-β measures as following; HOMA-β = fasting insulin (μU/mL) ×360/{fasting glucose (mg/dL) - 63}.
arm group label: Alogliptin
description: Alogliptin 25 milligram (mg), tablets, orally, once daily, up to 12 months, along with an insulin preparations, with a rapid-acting insulin secretagogue (Glinide), with a SGLT-2 inhibitor, or the other diabetic drugs within 3 months prior to the start of alogliptin treatment or during the alogliptin treatment period in routine medical care.
intervention type: Drug
intervention name: Alogliptin
description: Alogliptin tablets
arm group label: Alogliptin
other name: Nesina Tablets
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Study Director
role: Study Director
affiliation: Takeda
facility: 
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Alogliptin
sharing ipd: No
ipd description: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 