<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/NCT02989649</url>
  </required_header>
  <id_info>
    <org_study_id>Alogliptin-5009</org_study_id>
    <nct_id>NCT02989649</nct_id>
  </id_info>
  <brief_title>Non-Interventional Study of the Use of Alogliptin and Alogliptin Fixed-Dose Combinations With Pioglitazone and With Metformin in Standard Clinical Practice</brief_title>
  <official_title>A Prospective, Non-Interventional Study of the Use of Alogliptin and Alogliptin Fixed-Dose Combinations With Pioglitazone and With Metformin in Standard Clinical Practice</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Takeda</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Takeda</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to observe alogliptin and alogliptin fixed-dose combinations&#xD;
      (FDCs) utilization patterns, as well as clinical response to treatment with alogliptin or&#xD;
      alogliptin FDCs, in standard clinical practice.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The drug being studied in this study is called alogliptin and alogliptin FDCs. Alogliptin and&#xD;
      alogliptin FDCs is being researched to treat people who have diabetes mellitus type 2. This&#xD;
      study will look at the glycosylated hemoglobin (HbA1c) level dynamics in participants with&#xD;
      diabetes mellitus type 2.&#xD;
&#xD;
      The study enrolled 593 patients. Alogliptin and alogliptin FDCs will be prescribed by the&#xD;
      physician as part of participants' T2DM treatment program (independent of participation in&#xD;
      this study).&#xD;
&#xD;
      This multi-center study will be conducted in China. The overall duration of study for&#xD;
      observation will be approximately 6 months, or up to loss to follow-up or death, whichever&#xD;
      occurs first. Participants will make multiple visits to the clinic as per regular doctor's&#xD;
      appointments.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Business Decision; No Safety Or Efficacy Concerns&#xD;
  </why_stopped>
  <start_date type="Actual">December 22, 2016</start_date>
  <completion_date type="Actual">January 26, 2018</completion_date>
  <primary_completion_date type="Actual">January 26, 2018</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>Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6</measure>
    <time_frame>Baseline and Month 6</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 Month 6 relative to baseline. Glycosylated hemoglobin (HbA1c) as a diagnostic criteria of diabetes mellitus is ≥6.5%. A negative change from Baseline indicates improvement.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics</measure>
    <time_frame>Baseline and Month 6</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 Month 6 relative to baseline. Glycosylated hemoglobin (HbA1c) as a diagnostic criteria of diabetes mellitus is ≥6.5%. Subgroups included participants with different baseline clinical characteristics with predictors such as prior therapy of diabetes mellitus, sex, age group, cardiovascular risk group, therapy type (monotherapy or combined therapy), baseline body mass index (BMI) and initial glycemic control. A negative change from Baseline indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a Decrease in HbA1c Level by &lt;7.0%</measure>
    <time_frame>Baseline and Month 6</time_frame>
    <description>Percentage of participants with a decrease of &lt;7.0% from baseline in HbA1c were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a Decrease in HbA1c Level by &gt;0.3% and No Tolerability Findings</measure>
    <time_frame>Baseline and Month 6</time_frame>
    <description>Percentage of participants with a decrease of &gt;0.3% from baseline in HbA1c along with no tolerability findings were reported. Tolerability findings included hypoglycemic event, or weight gain ≥5%.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Fasting Plasma Glucose (FPG) Level Over Time</measure>
    <time_frame>Baseline and Months 3 and 6</time_frame>
    <description>The change between the fasting plasma glucose value collected at Months 3 and 6 relative to baseline. A negative change from Baseline indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level Over Time</measure>
    <time_frame>Baseline and Months 3 and 6</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 Months 3 and 6 relative to baseline. A negative change from Baseline indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)</measure>
    <time_frame>Baseline up to Month 6</time_frame>
    <description>An ADR is defined as any response to a medicinal product that is noxious and unintended and that occurs at doses normally used in humans for the prophylaxis, diagnosis, or therapy of diseases or for the restoration, correction, or modification of physiological function. An SAE is defined as any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria. Adverse events such as pancreatitis, hepatic disorders, and hypersensitivity reactions (including angioedema, anaphylaxis, and Stevens-Johnson syndrome) were considered as AESI.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Remain on Treatment With Alogliptin or Alogliptin FDCs</measure>
    <time_frame>Months 3 and 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Alogliptin or Alogliptin FDCs Dose Escalation or Dose Reduction</measure>
    <time_frame>Months 3 and 6</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">593</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)</arm_group_label>
    <description>Participants with type 2 diabetes mellitus (T2DM) who received alogliptin or alogliptin FDCs, orally, prescribed by the physician as part of participants' T2DM treatment program (independent of participation in this study) were observed for approximately 6 months, or up to loss to follow-up or death, whichever occurred first.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Alogliptin</intervention_name>
    <description>Alogliptin tablets</description>
    <arm_group_label>Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Alogliptin FDC With Pioglitazone</intervention_name>
    <description>Alogliptin FDC with pioglitazone tablets</description>
    <arm_group_label>Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Alogliptin FDC With Metformin</intervention_name>
    <description>Alogliptin FDC with metformin tablets</description>
    <arm_group_label>Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult participants diagnosed with type 2 diabetes mellitus (T2DM) will be observed.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Has a diagnosis of T2DM.&#xD;
&#xD;
          2. Has made the decision, along with his/her treating physician, to begin treatment with&#xD;
             alogliptin or alogliptin fixed-dose combinations (FDCs).&#xD;
&#xD;
          3. Has an glycated hemoglobin (HbA1c) value recorded at most 3 months before initiation&#xD;
             of treatment with alogliptin or alogliptin FDCs.&#xD;
&#xD;
          4. Alogliptin or alogliptin FDCs is prescribed according to the approved label for China&#xD;
             and Hong Kong.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Has gestational diabetes or type 1 diabetes mellitus.&#xD;
&#xD;
          2. Has used Dipeptidyl peptidase-4 inhibitors (DPP-IV inhibitors) or Glucagon like&#xD;
             peptide-1 agonists (aGLP-1) within the 3 months prior to the start of alogliptin or&#xD;
             alogliptin FDCs treatment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director Clinical Science</last_name>
    <role>Study Director</role>
    <affiliation>Takeda</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dalian</city>
        <state>Liaoning</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Qingdao</city>
        <state>Shandong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tai'an</city>
        <state>Shandong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Taian</city>
        <state>Shandong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sai Ying Pun</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sha Tin</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 8, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <results_first_submitted>January 23, 2019</results_first_submitted>
  <results_first_submitted_qc>January 23, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">April 19, 2019</results_first_posted>
  <last_update_submitted>January 23, 2019</last_update_submitted>
  <last_update_submitted_qc>January 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Drug Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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>Metformin</mesh_term>
    <mesh_term>Pioglitazone</mesh_term>
    <mesh_term>Alogliptin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach 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>April 1, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/49/NCT02989649/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>March 12, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/49/NCT02989649/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants took part in the study at 16 investigative sites in China from 22 Dec 2016 to 26 Jan 2018.</recruitment_details>
      <pre_assignment_details>Participants with a diagnosis of Type 2 Diabetes Mellitus (T2DM) prescribed alogliptin or alogliptin Fixed Dose Combinations (FDCs) with either metformin or pioglitazone were enrolled in this observational study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)</title>
          <description>Participants with type 2 diabetes mellitus (T2DM) who received alogliptin or alogliptin FDCs, orally, prescribed by the physician as part of participants' T2DM treatment program (independent of participation in this study) were observed for approximately 6 months, or up to loss to follow-up or death, whichever occurred first.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="593"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Started But Not Treated</title>
              <participants_list>
                <participants group_id="P1" count="84"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Eligible to Enter Into Treatment Period</title>
              <participants_list>
                <participants group_id="P1" count="509"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="173"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="420"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Patient/Investigator's Decision to Stop</title>
              <participants_list>
                <participants group_id="P1" count="403"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event/Adverse Drug Reaction</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost For Observation During Study</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Reason Not Specified</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All participants dosed included participants with complete demographic information and eligible for the study and dosed at least once.</population>
      <group_list>
        <group group_id="B1">
          <title>Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)</title>
          <description>Participants with type 2 diabetes mellitus (T2DM) who received alogliptin or alogliptin FDCs, orally, prescribed by the physician as part of participants' T2DM treatment program (independent of participation in this study) were observed for approximately 6 months, or up to loss to follow-up or death, whichever occurred first.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="509"/>
          </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="509"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55.3" spread="12.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</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="509"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;45 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="92"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=45 to &lt;65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="309"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="108"/>
                  </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="509"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="207"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="302"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</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="509"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="508"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</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="509"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Han Nationality</title>
                  <measurement_list>
                    <measurement group_id="B1" value="504"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>China</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="509"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="509"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <population>Number analyzed is the number of participants with evaluable data for this baseline measure.</population>
          <units>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="500"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="167.37" spread="8.089"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <population>Number analyzed is the number of participants with evaluable data for this baseline measure.</population>
          <units>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="500"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="72.66" spread="12.208"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <description>Body Mass Index(BMI)=weight (kg)/[height (m)^2]. BMI is calculated using the participant's baseline height and weight measurement.</description>
          <population>Number analyzed is the number of participants with evaluable data for this baseline measure.</population>
          <units>kg/m^2</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="500"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25.86" spread="3.500"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index, Customized</title>
          <description>Body Mass Index(BMI)=weight (kg)/[height (m)^2]. BMI is calculated using the participant's baseline height and weight measurement.</description>
          <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="509"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;25 kg/m^2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="193"/>
                  </measurement_list>
                </category>
                <category>
                  <title>25 to &lt;30 kg/m^2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="256"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=30 kg/m^2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Glycosylated hemoglobin (HbA1c) Level</title>
          <description>Glycosylated hemoglobin is the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound. Glycosylated hemoglobin as a diagnostic criteria of diabetes mellitus is ≥6.5%.</description>
          <population>Number analyzed is the number of participants with evaluable data for this baseline measure.</population>
          <units>percentage of glycosylated hemoglobin</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="498"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.690" spread="1.8807"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6</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 Month 6 relative to baseline. Glycosylated hemoglobin (HbA1c) as a diagnostic criteria of diabetes mellitus is ≥6.5%. A negative change from Baseline indicates improvement.</description>
        <time_frame>Baseline and Month 6</time_frame>
        <population>All participants dosed included participants with complete demographic information and eligible for the study and dosed at least once. Overall number of participants analyzed is the number of participants with evaluable data at the given time-point.</population>
        <group_list>
          <group group_id="O1">
            <title>Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)</title>
            <description>Participants with type 2 diabetes mellitus (T2DM) who received alogliptin or alogliptin FDCs, orally, prescribed by the physician as part of participants' T2DM treatment program (independent of participation in this study) were observed for approximately 6 months, or up to loss to follow-up or death, whichever occurred first.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6</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 Month 6 relative to baseline. Glycosylated hemoglobin (HbA1c) as a diagnostic criteria of diabetes mellitus is ≥6.5%. A negative change from Baseline indicates improvement.</description>
          <population>All participants dosed included participants with complete demographic information and eligible for the study and dosed at least once. Overall number of participants analyzed is the number of participants with evaluable data at the given time-point.</population>
          <units>percentage of glycosylated hemoglobin</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="140"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.092" spread="1.6803"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis for data at Baseline compared to the data at Month 6</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Regression, Linear</method>
            <param_type>Least Square Mean (LSM)</param_type>
            <param_value>-1.25</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.098</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.44</ci_lower_limit>
            <ci_upper_limit>-1.05</ci_upper_limit>
            <estimate_desc>The LSM and CI are from Mixed effect Model Repeat Measurement (MMRM) model, that used visit as a predictor and baseline value as a covariate. For change from baseline, covariance structure=Unstructured.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics</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 Month 6 relative to baseline. Glycosylated hemoglobin (HbA1c) as a diagnostic criteria of diabetes mellitus is ≥6.5%. Subgroups included participants with different baseline clinical characteristics with predictors such as prior therapy of diabetes mellitus, sex, age group, cardiovascular risk group, therapy type (monotherapy or combined therapy), baseline body mass index (BMI) and initial glycemic control. A negative change from Baseline indicates improvement.</description>
        <time_frame>Baseline and Month 6</time_frame>
        <population>All participants dosed included participants with complete demographic information and eligible for the study and dosed at least once. Overall number of participants analyzed is the number of participants with evaluable data at the given time-point.</population>
        <group_list>
          <group group_id="O1">
            <title>Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)</title>
            <description>Participants with type 2 diabetes mellitus (T2DM) who received alogliptin or alogliptin FDCs, orally, prescribed by the physician as part of participants' T2DM treatment program (independent of participation in this study) were observed for approximately 6 months, or up to loss to follow-up or death, whichever occurred first.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics</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 Month 6 relative to baseline. Glycosylated hemoglobin (HbA1c) as a diagnostic criteria of diabetes mellitus is ≥6.5%. Subgroups included participants with different baseline clinical characteristics with predictors such as prior therapy of diabetes mellitus, sex, age group, cardiovascular risk group, therapy type (monotherapy or combined therapy), baseline body mass index (BMI) and initial glycemic control. A negative change from Baseline indicates improvement.</description>
          <population>All participants dosed included participants with complete demographic information and eligible for the study and dosed at least once. Overall number of participants analyzed is the number of participants with evaluable data at the given time-point.</population>
          <units>percentage of glycosylated hemoglobin</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="140"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Prior Therapy of Diabetes Mellitus, Ever Used</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="108"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.154" spread="1.7555"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prior Therapy of Diabetes Mellitus, Never Used</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.882" spread="1.4015"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sex, Male</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.055" spread="1.5898"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sex, Female</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.150" spread="1.8292"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age, &lt;45 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.658" spread="1.8206"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age, &gt;=45 to &lt;65 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.370" spread="1.7121"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age,&gt;=65 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.203" spread="1.1423"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cardiovascular Risk Group, Yes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.100" spread="2.4973"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cardiovascular Risk Group, No</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="133"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.092" spread="1.6400"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Therapy Type, Monotherapy</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.032" spread="1.5122"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Therapy Type, Combined Therapy</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="114"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.106" spread="1.7222"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline BMI, &lt;25 kg/m^2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.101" spread="1.7339"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline BMI, 25 to &lt;30 kg/m^2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.037" spread="1.6151"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline BMI, &gt;=30 kg/m^2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.342" spread="1.8530"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Initial Glycemic Control, &lt;7%</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.046" spread="0.7345"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Initial Glycemic Control, &gt;=7%</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.525" spread="1.7713"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis for subgroup: Prior therapy of diabetes mellitus, Ever used or Never used</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.423</p_value>
            <method>Regression, Linear</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis for subgroup: Sex, Male or Female</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.747</p_value>
            <method>Regression, Linear</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis for subgroup: Age, &lt;45 or &gt;=45 to &lt;65 years or &gt;=65 years</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Regression, Linear</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis for subgroup: Cardiovascular risk group, Yes or No</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.990</p_value>
            <method>Regression, Linear</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis for subgroup: Therapy type, Monotherapy or Combined therapy</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.841</p_value>
            <method>Regression, Linear</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis for subgroup: Baseline BMI, &lt;25 or 25 to &lt;30 or &gt;=30 kg/m^2</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.847</p_value>
            <method>Regression, Linear</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis for subgroup: Initial glycemic control, &lt;7% or &gt;=7%</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Regression, Linear</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a Decrease in HbA1c Level by &lt;7.0%</title>
        <description>Percentage of participants with a decrease of &lt;7.0% from baseline in HbA1c were reported.</description>
        <time_frame>Baseline and Month 6</time_frame>
        <population>All participants dosed included participants with complete demographic information and eligible for the study and dosed at least once. Overall number of participants analyzed is the number of participants with evaluable data at the given time-point.</population>
        <group_list>
          <group group_id="O1">
            <title>Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)</title>
            <description>Participants with type 2 diabetes mellitus (T2DM) who received alogliptin or alogliptin FDCs, orally, prescribed by the physician as part of participants' T2DM treatment program (independent of participation in this study) were observed for approximately 6 months, or up to loss to follow-up or death, whichever occurred first.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a Decrease in HbA1c Level by &lt;7.0%</title>
          <description>Percentage of participants with a decrease of &lt;7.0% from baseline in HbA1c were reported.</description>
          <population>All participants dosed included participants with complete demographic information and eligible for the study and dosed at least once. Overall number of participants analyzed is the number of participants with evaluable data at the given time-point.</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="147"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.0" lower_limit="0.43" upper_limit="0.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a Decrease in HbA1c Level by &gt;0.3% and No Tolerability Findings</title>
        <description>Percentage of participants with a decrease of &gt;0.3% from baseline in HbA1c along with no tolerability findings were reported. Tolerability findings included hypoglycemic event, or weight gain ≥5%.</description>
        <time_frame>Baseline and Month 6</time_frame>
        <population>All participants dosed included participants with complete demographic information and eligible for the study and dosed at least once. Overall number of participants analyzed is the number of participants with evaluable data at the given time-point.</population>
        <group_list>
          <group group_id="O1">
            <title>Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)</title>
            <description>Participants with type 2 diabetes mellitus (T2DM) who received alogliptin or alogliptin FDCs, orally, prescribed by the physician as part of participants' T2DM treatment program (independent of participation in this study) were observed for approximately 6 months, or up to loss to follow-up or death, whichever occurred first.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a Decrease in HbA1c Level by &gt;0.3% and No Tolerability Findings</title>
          <description>Percentage of participants with a decrease of &gt;0.3% from baseline in HbA1c along with no tolerability findings were reported. Tolerability findings included hypoglycemic event, or weight gain ≥5%.</description>
          <population>All participants dosed included participants with complete demographic information and eligible for the study and dosed at least once. Overall number of participants analyzed is the number of participants with evaluable data at the given time-point.</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="140"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64.3" lower_limit="0.56" upper_limit="0.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Fasting Plasma Glucose (FPG) Level Over Time</title>
        <description>The change between the fasting plasma glucose value collected at Months 3 and 6 relative to baseline. A negative change from Baseline indicates improvement.</description>
        <time_frame>Baseline and Months 3 and 6</time_frame>
        <population>All participants dosed included participants with complete demographic information and eligible for the study and dosed at least once. Number analyzed is the number of participants with evaluable data at the given time-point.</population>
        <group_list>
          <group group_id="O1">
            <title>Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)</title>
            <description>Participants with type 2 diabetes mellitus (T2DM) who received alogliptin or alogliptin FDCs, orally, prescribed by the physician as part of participants' T2DM treatment program (independent of participation in this study) were observed for approximately 6 months, or up to loss to follow-up or death, whichever occurred first.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Fasting Plasma Glucose (FPG) Level Over Time</title>
          <description>The change between the fasting plasma glucose value collected at Months 3 and 6 relative to baseline. A negative change from Baseline indicates improvement.</description>
          <population>All participants dosed included participants with complete demographic information and eligible for the study and dosed at least once. Number analyzed is the number of participants with evaluable data at the given time-point.</population>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="509"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="213"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.058" spread="3.0026"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.714" spread="2.9802"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis for data at Baseline compared to the data at Month 3</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Least Square Mean (LSM)</param_type>
            <param_value>-0.95</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.170</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.29</ci_lower_limit>
            <ci_upper_limit>-0.62</ci_upper_limit>
            <estimate_desc>The LSM and CI are from Mixed effect Model Repeat Measurement (MMRM) model, that used visit as a predictor and baseline value as a covariate. For change from baseline, covariance structure=Unstructured.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis for data at Baseline compared to the data at Month 6</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Least Square Mean (LSM)</param_type>
            <param_value>-0.87</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.245</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.36</ci_lower_limit>
            <ci_upper_limit>-0.39</ci_upper_limit>
            <estimate_desc>The LSM and CI are from Mixed effect Model Repeat Measurement (MMRM) model, that used visit as a predictor and baseline value as a covariate. For change from baseline, covariance structure=Unstructured.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level Over Time</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 Months 3 and 6 relative to baseline. A negative change from Baseline indicates improvement.</description>
        <time_frame>Baseline and Months 3 and 6</time_frame>
        <population>All participants dosed included participants with complete demographic information and eligible for the study and dosed at least once. Number analyzed is the number of participants with evaluable data at the given time-point.</population>
        <group_list>
          <group group_id="O1">
            <title>Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)</title>
            <description>Participants with type 2 diabetes mellitus (T2DM) who received alogliptin or alogliptin FDCs, orally, prescribed by the physician as part of participants' T2DM treatment program (independent of participation in this study) were observed for approximately 6 months, or up to loss to follow-up or death, whichever occurred first.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level Over Time</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 Months 3 and 6 relative to baseline. A negative change from Baseline indicates improvement.</description>
          <population>All participants dosed included participants with complete demographic information and eligible for the study and dosed at least once. Number analyzed is the number of participants with evaluable data at the given time-point.</population>
          <units>percentage of glycosylated hemoglobin</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="509"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="332"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.022" spread="2.3669"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="140"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.092" spread="1.6803"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis for data at Baseline compared to the data at Month 3</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Least Square Mean (LSM)</param_type>
            <param_value>-0.95</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.117</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.18</ci_lower_limit>
            <ci_upper_limit>-0.72</ci_upper_limit>
            <estimate_desc>The LSM and CI are from Mixed effect Model Repeat Measurement (MMRM) model, that used visit as a predictor and baseline value as a covariate. For change from baseline, covariance structure=Unstructured.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis for data at Baseline compared to the data at Month 6</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Least Square Mean</param_type>
            <param_value>-1.25</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.098</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.44</ci_lower_limit>
            <ci_upper_limit>-1.05</ci_upper_limit>
            <estimate_desc>The LSM and CI are from Mixed effect Model Repeat Measurement (MMRM) model, that used visit as a predictor and baseline value as a covariate. For change from baseline, covariance structure=Unstructured.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)</title>
        <description>An ADR is defined as any response to a medicinal product that is noxious and unintended and that occurs at doses normally used in humans for the prophylaxis, diagnosis, or therapy of diseases or for the restoration, correction, or modification of physiological function. An SAE is defined as any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria. Adverse events such as pancreatitis, hepatic disorders, and hypersensitivity reactions (including angioedema, anaphylaxis, and Stevens-Johnson syndrome) were considered as AESI.</description>
        <time_frame>Baseline up to Month 6</time_frame>
        <population>All participants dosed included participants with complete demographic information and eligible for the study and dosed at least once.</population>
        <group_list>
          <group group_id="O1">
            <title>Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)</title>
            <description>Participants with type 2 diabetes mellitus (T2DM) who received alogliptin or alogliptin FDCs, orally, prescribed by the physician as part of participants' T2DM treatment program (independent of participation in this study) were observed for approximately 6 months, or up to loss to follow-up or death, whichever occurred first.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)</title>
          <description>An ADR is defined as any response to a medicinal product that is noxious and unintended and that occurs at doses normally used in humans for the prophylaxis, diagnosis, or therapy of diseases or for the restoration, correction, or modification of physiological function. An SAE is defined as any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria. Adverse events such as pancreatitis, hepatic disorders, and hypersensitivity reactions (including angioedema, anaphylaxis, and Stevens-Johnson syndrome) were considered as AESI.</description>
          <population>All participants dosed included participants with complete demographic information and eligible for the study and dosed at least once.</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="509"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Adverse Drug Reaction (ADR)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serious Adverse Event (SAE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adverse Event of Special Interest (AESI)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Remain on Treatment With Alogliptin or Alogliptin FDCs</title>
        <time_frame>Months 3 and 6</time_frame>
        <population>All participants dosed included participants with complete demographic information and eligible for the study and dosed at least once. Number analyzed is the number of participants with evaluable data at the given time-point.</population>
        <group_list>
          <group group_id="O1">
            <title>Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)</title>
            <description>Participants with type 2 diabetes mellitus (T2DM) who received alogliptin or alogliptin FDCs, orally, prescribed by the physician as part of participants' T2DM treatment program (independent of participation in this study) were observed for approximately 6 months, or up to loss to follow-up or death, whichever occurred first.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Remain on Treatment With Alogliptin or Alogliptin FDCs</title>
          <population>All participants dosed included participants with complete demographic information and eligible for the study and dosed at least once. Number analyzed is the number of participants with evaluable data at the given time-point.</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="509"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="380"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="154"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Alogliptin or Alogliptin FDCs Dose Escalation or Dose Reduction</title>
        <time_frame>Months 3 and 6</time_frame>
        <population>No participant was experienced the dose adjustment (dose escalation or dose reduction).</population>
        <group_list>
          <group group_id="O1">
            <title>Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)</title>
            <description>Participants with type 2 diabetes mellitus (T2DM) who received alogliptin or alogliptin FDCs, orally, prescribed by the physician as part of participants' T2DM treatment program (independent of participation in this study) were observed for approximately 6 months, or up to loss to follow-up or death, whichever occurred first.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Alogliptin or Alogliptin FDCs Dose Escalation or Dose Reduction</title>
          <population>No participant was experienced the dose adjustment (dose escalation or dose reduction).</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to Month 6</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.</desc>
      <group_list>
        <group group_id="E1">
          <title>Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)</title>
          <description>Participants with type 2 diabetes mellitus (T2DM) who received alogliptin or alogliptin FDCs, orally, prescribed by the physician as part of participants' T2DM treatment program (independent of participation in this study) were observed for approximately 6 months, or up to loss to follow-up or death, whichever occurred first.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="509"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="509"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA version 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="55" subjects_at_risk="509"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="48" subjects_at_risk="509"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="509"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="509"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertriglyceridaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="509"/>
              </event>
              <event>
                <sub_title>Dyslipidaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="509"/>
              </event>
              <event>
                <sub_title>Hyperuricaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="509"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="509"/>
              </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/NCT02989649
org study id: Alogliptin-5009
nct id: NCT02989649
lead sponsor: 
has dmc: No
The purpose of this study is to observe alogliptin and alogliptin fixed-dose combinations
      (FDCs) utilization patterns, as well as clinical response to treatment with alogliptin or
      alogliptin FDCs, in standard clinical practice.
The drug being studied in this study is called alogliptin and alogliptin FDCs. Alogliptin and
      alogliptin FDCs is being researched to treat people who have diabetes mellitus type 2. This
      study will look at the glycosylated hemoglobin (HbA1c) level dynamics in participants with
      diabetes mellitus type 2.

      The study enrolled 593 patients. Alogliptin and alogliptin FDCs will be prescribed by the
      physician as part of participants' T2DM treatment program (independent of participation in
      this study).

      This multi-center study will be conducted in China. The overall duration of study for
      observation will be approximately 6 months, or up to loss to follow-up or death, whichever
      occurs first. Participants will make multiple visits to the clinic as per regular doctor's
      appointments.
observational model: Cohort
time perspective: Prospective
measure: Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6
time frame: Baseline and Month 6
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 Month 6 relative to baseline. Glycosylated hemoglobin (HbA1c) as a diagnostic criteria of diabetes mellitus is ≥6.5%. A negative change from Baseline indicates improvement.
measure: Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics
time frame: Baseline and Month 6
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 Month 6 relative to baseline. Glycosylated hemoglobin (HbA1c) as a diagnostic criteria of diabetes mellitus is ≥6.5%. Subgroups included participants with different baseline clinical characteristics with predictors such as prior therapy of diabetes mellitus, sex, age group, cardiovascular risk group, therapy type (monotherapy or combined therapy), baseline body mass index (BMI) and initial glycemic control. A negative change from Baseline indicates improvement.
measure: Percentage of Participants With a Decrease in HbA1c Level by <7.0%
time frame: Baseline and Month 6
description: Percentage of participants with a decrease of <7.0% from baseline in HbA1c were reported.
measure: Percentage of Participants With a Decrease in HbA1c Level by >0.3% and No Tolerability Findings
time frame: Baseline and Month 6
description: Percentage of participants with a decrease of >0.3% from baseline in HbA1c along with no tolerability findings were reported. Tolerability findings included hypoglycemic event, or weight gain ≥5%.
measure: Change From Baseline in Fasting Plasma Glucose (FPG) Level Over Time
time frame: Baseline and Months 3 and 6
description: The change between the fasting plasma glucose value collected at Months 3 and 6 relative to baseline. A negative change from Baseline indicates improvement.
measure: Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level Over Time
time frame: Baseline and Months 3 and 6
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 Months 3 and 6 relative to baseline. A negative change from Baseline indicates improvement.
measure: Number of Participants With Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
time frame: Baseline up to Month 6
description: An ADR is defined as any response to a medicinal product that is noxious and unintended and that occurs at doses normally used in humans for the prophylaxis, diagnosis, or therapy of diseases or for the restoration, correction, or modification of physiological function. An SAE is defined as any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria. Adverse events such as pancreatitis, hepatic disorders, and hypersensitivity reactions (including angioedema, anaphylaxis, and Stevens-Johnson syndrome) were considered as AESI.
measure: Percentage of Participants Who Remain on Treatment With Alogliptin or Alogliptin FDCs
time frame: Months 3 and 6
measure: Time to Alogliptin or Alogliptin FDCs Dose Escalation or Dose Reduction
time frame: Months 3 and 6
arm group label: Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)
description: Participants with type 2 diabetes mellitus (T2DM) who received alogliptin or alogliptin FDCs, orally, prescribed by the physician as part of participants' T2DM treatment program (independent of participation in this study) were observed for approximately 6 months, or up to loss to follow-up or death, whichever occurred first.
intervention type: Drug
intervention name: Alogliptin
description: Alogliptin tablets
arm group label: Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)
intervention type: Drug
intervention name: Alogliptin FDC With Pioglitazone
description: Alogliptin FDC with pioglitazone tablets
arm group label: Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)
intervention type: Drug
intervention name: Alogliptin FDC With Metformin
description: Alogliptin FDC with metformin tablets
arm group label: Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Director Clinical Science
role: Study Director
affiliation: Takeda
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country: China
country: Hong Kong
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 2
mesh term: Metformin
mesh term: Pioglitazone
mesh term: Alogliptin
sharing ipd: Yes
ipd description: Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach 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: 
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participant flow: 
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