<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/NCT03014479</url>
  </required_header>
  <id_info>
    <org_study_id>Trelagliptin-4002</org_study_id>
    <secondary_id>JapicCTI-173482</secondary_id>
    <secondary_id>U1111-1189-9256</secondary_id>
    <nct_id>NCT03014479</nct_id>
  </id_info>
  <brief_title>Study of the QOL Evaluation of Trelagliptin in Patients With Type 2 Diabetes Mellitus</brief_title>
  <acronym>TRENDS</acronym>
  <official_title>Study of the QOL Evaluation of Trelagliptin in Patients With Type 2 Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Takeda</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Takeda</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the reduction in treatment burden during 12 weeks of&#xD;
      trelagliptin administration in patients with type 2 diabetes on diet and exercise therapy&#xD;
      only.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to assess the reduction in treatment burden during 12 weeks of&#xD;
      trelagliptin administration in patients with type 2 diabetes on diet and exercise therapy&#xD;
      only. Eligible participants will be randomized to either the study drug (trelagliptin) group&#xD;
      or the comparative drug (daily DPP-4 inhibitor) group. Treatment burden will be assessed&#xD;
      using Diabetes Therapy Related -QOL (DTR-QOL) questionnaire and Diabetes Treatment&#xD;
      Satisfaction Questionnaire (DTSQ).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 18, 2017</start_date>
  <completion_date type="Actual">October 21, 2017</completion_date>
  <primary_completion_date type="Actual">October 21, 2017</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Total Score for All Question Items in the Diabetes Therapy Related -QOL (DTR-QOL) Questionnaire at the End of Study</measure>
    <time_frame>Baseline (Week 0), up to the end of study (Week 12)</time_frame>
    <description>DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13 questions), Factor 2: Anxiety and dissatisfaction with treatment (8 questions), Factor 3: Hypoglycemia (4 questions) and Factor 4: Treatment satisfaction (4 questions). Each item is scored ranging from 1 to 7. Every score of the questions in Factor 1-3 and the score in Factor 4 converted into reverse (1-7 will be converted to 7-1) will be simply added up, and scores of each factor and the total figure will be subsequently converted from 0 to 100 (the best and worst scores will be equivalent to 100 and 0). Higher scores reflect better QOL and positive changes relative to baseline indicate improvement of QOL.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Total Score for Each Factor Provided Through the DTR-QOL Questionnaire [Factor 1: Burden on Social Activities and Daily Activities] at Each Assessment Time Point</measure>
    <time_frame>Baseline (Week 0), up to Week 4, 12, and the end of study (Week 12)</time_frame>
    <description>DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13 questions), Factor 2: Anxiety and dissatisfaction with treatment (8 questions), Factor 3: Hypoglycemia (4 questions) and Factor 4: Treatment satisfaction (4 questions). Each item is scored ranging from 1 to 7. Every score of the questions in Factor 1-3 and the score in Factor 4 converted into reverse (1-7 will be converted to 7-1) will be simply added up, and scores of each factor and the total figure will be subsequently converted from 0 to 100 (the best and worst scores will be equivalent to 100 and 0). Higher scores reflect better QOL and positive changes relative to baseline indicate improvement of QOL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Total Score for Each Factor Provided Through the DTR-QOL Questionnaire [Factor 2: Anxiety and Dissatisfaction With Treatments] at Each Assessment Time Point</measure>
    <time_frame>Baseline (Week 0), up to Week 4, 12, and the end of study (Week 12)</time_frame>
    <description>DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13 questions), Factor 2: Anxiety and dissatisfaction with treatment (8 questions), Factor 3: Hypoglycemia (4 questions) and Factor 4: Treatment satisfaction (4 questions). Each item is scored ranging from 1 to 7. Every score of the questions in Factor 1-3 and the score in Factor 4 converted into reverse (1-7 will be converted to 7-1) will be simply added up, and scores of each factor and the total figure will be subsequently converted from 0 to 100 (the best and worst scores will be equivalent to 100 and 0). Higher scores reflect better QOL and positive changes relative to baseline indicate improvement of QOL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Total Score for Each Factor Provided Through the DTR-QOL Questionnaire [Factor 3: Hypoglycemia] at Each Assessment Time Point</measure>
    <time_frame>Baseline (Week 0), up to Week 4, 12, and the end of study (Week 12)</time_frame>
    <description>DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13 questions), Factor 2: Anxiety and dissatisfaction with treatment (8 questions), Factor 3: Hypoglycemia (4 questions) and Factor 4: Treatment satisfaction (4 questions). Each item is scored ranging from 1 to 7. Every score of the questions in Factor 1-3 and the score in Factor 4 converted into reverse (1-7 will be converted to 7-1) will be simply added up, and scores of each factor and the total figure will be subsequently converted from 0 to 100 (the best and worst scores will be equivalent to 100 and 0). Higher scores reflect better QOL and positive changes relative to baseline indicate improvement of QOL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Total Score for Each Factor Provided Through the DTR-QOL Questionnaire [Factor 4: Satisfaction With Treatment] at Each Assessment Time Point</measure>
    <time_frame>Baseline (Week 0), up to Week 4, 12, and the end of study (Week 12)</time_frame>
    <description>DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13 questions), Factor 2: Anxiety and dissatisfaction with treatment (8 questions), Factor 3: Hypoglycemia (4 questions) and Factor 4: Treatment satisfaction (4 questions). Each item is scored ranging from 1 to 7. Every score of the questions in Factor 1-3 and the score in Factor 4 converted into reverse (1-7 will be converted to 7-1) will be simply added up, and scores of each factor and the total figure will be subsequently converted from 0 to 100 (the best and worst scores will be equivalent to 100 and 0). Higher scores reflect better QOL and positive changes relative to baseline indicate improvement of QOL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Total Score for All Question Items in the DTR-QOL Questionnaire at Each Assessment Time Point</measure>
    <time_frame>Baseline (Week 0), up to Week 4, 12</time_frame>
    <description>DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13 questions), Factor 2: Anxiety and dissatisfaction with treatment (8 questions), Factor 3: Hypoglycemia (4 questions) and Factor 4: Treatment satisfaction (4 questions). Each item is scored ranging from 1 to 7. Every score of the questions in Factor 1-3 and the score in Factor 4 converted into reverse (1-7 will be converted to 7-1) will be simply added up, and scores of each factor and the total figure will be subsequently converted from 0 to 100 (the best and worst scores will be equivalent to 100 and 0). Higher scores reflect better QOL and positive changes relative to baseline indicate improvement of QOL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Total Score for Questions About Treatment Satisfaction in the Diabetes Treatment Satisfaction Questionnaire (DTSQ) at Each Assessment Time Point</measure>
    <time_frame>Baseline (Week 0), up to Week 4, 12 and the end of study (Week 12)</time_frame>
    <description>The DTSQ is a self-reported instrument consists of 6 questions about treatment satisfaction and 2 questions regarding blood sugar level. Each question answered on a 7-point Likert scale from 0 to 6, based on concern with the diabetes treatment and experiences in the past few weeks. Higher total score for questions about treatment satisfaction indicate greater satisfaction with treatment and experiences.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Total Score for All Question Items in the DTR-QOL Questionnaire at the End of Study Stratified by the Use of Medication for Treatment of Comorbidities at Baseline</measure>
    <time_frame>Baseline (Week 0), up to the end of study (Week 12)</time_frame>
    <description>DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13 questions), Factor 2: Anxiety and dissatisfaction with treatment (8 questions), Factor 3: Hypoglycemia (4 questions) and Factor 4: Treatment satisfaction (4 questions). Each item is scored ranging from 1 to 7. Every score of the questions in Factor 1-3 and the score in Factor 4 converted into reverse (1-7 will be converted to 7-1) will be simply added up, and scores of each factor and the total figure will be subsequently converted from 0 to 100 (the best and worst scores will be equivalent to 100 and 0). Higher scores reflect better QOL and positive changes relative to baseline indicate improvement of QOL. Reported data was the score stratified by the use of medication for treatment of comorbidities at baseline (Used/ Not used).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Total Score for Questions About Treatment Satisfaction in the DTSQ at the End of Study Stratified by the Use of Medication for Treatment of Comorbidities at Baseline</measure>
    <time_frame>Baseline (Week 0), up to the end of study (Week 12)</time_frame>
    <description>The DTSQ is a self-reported instrument consists of 6 questions about treatment satisfaction and 2 questions regarding blood sugar level. Each question answered on a 7-point Likert scale from 0 to 6, based on concern with the diabetes treatment and experiences in the past few weeks. Higher total score for questions about treatment satisfaction indicate greater satisfaction with treatment and experiences. Reported data was the score stratified by the use of medication for treatment of comorbidities at baseline (Used/ Not used).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Total Score for All Question Items in the DTR-QOL Questionnaire at the End of Study Stratified by the Number of Daily Doses of Medication for Treatment of Comorbidities (&lt;2 Times or ≥2 Times) at Baseline</measure>
    <time_frame>Baseline (Week 0), up to the end of study (Week 12)</time_frame>
    <description>DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13 questions), Factor 2: Anxiety and dissatisfaction with treatment (8 questions), Factor 3: Hypoglycemia (4 questions) and Factor 4: Treatment satisfaction (4 questions). Each item is scored ranging from 1 to 7. Every score of the questions in Factor 1-3 and the score in Factor 4 converted into reverse (1-7 will be converted to 7-1) will be simply added up, and scores of each factor and the total figure will be subsequently converted from 0 to 100 (the best and worst scores will be equivalent to 100 and 0). Higher scores reflect better QOL and positive changes relative to baseline indicate improvement of QOL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Total Score for Questions About Treatment Satisfaction in the DTSQ at the End of Study Stratified by the Number of Daily Doses of Medication for Treatment of Comorbidities (&lt;2 Times or ≥2 Times) at Baseline</measure>
    <time_frame>Baseline (Week 0), up to the end of study (Week 12)</time_frame>
    <description>The DTSQ is a self-reported instrument consists of 6 questions about treatment satisfaction and 2 questions regarding blood sugar level. Each question answered on a 7-point Likert scale from 0 to 6, based on concern with the diabetes treatment and experiences in the past few weeks. Higher total score for questions about treatment satisfaction indicate greater satisfaction with treatment and experiences.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Total Score for All Question Items in the DTR-QOL Questionnaire at the End of Study Stratified by the Total Number of Daily Tablets of Medication for Treatment of Comorbidities (&lt;2 Tablets or ≥2 Tablets) at Baseline</measure>
    <time_frame>Baseline (Week 0), up to the end of study (Week 12)</time_frame>
    <description>DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13 questions), Factor 2: Anxiety and dissatisfaction with treatment (8 questions), Factor 3: Hypoglycemia (4 questions) and Factor 4: Treatment satisfaction (4 questions). Each item is scored ranging from 1 to 7. Every score of the questions in Factor 1-3 and the score in Factor 4 converted into reverse (1-7 will be converted to 7-1) will be simply added up, and scores of each factor and the total figure will be subsequently converted from 0 to 100 (the best and worst scores will be equivalent to 100 and 0). Higher scores reflect better QOL and positive changes relative to baseline indicate improvement of QOL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Total Score for Questions About Treatment Satisfaction in the DTSQ at the End of Study Stratified by the Total Number of Daily Tablets of Medication for Treatment of Comorbidities (&lt;2 Tablets or ≥2 Tablets) at Baseline</measure>
    <time_frame>Baseline (Week 0), up to the end of study (Week 12)</time_frame>
    <description>The DTSQ is a self-reported instrument consists of 6 questions about treatment satisfaction and 2 questions regarding blood sugar level. Each question answered on a 7-point Likert scale from 0 to 6, based on concern with the diabetes treatment and experiences in the past few weeks. Higher total score for questions about treatment satisfaction indicate greater satisfaction with treatment and experiences.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Total Score for All Question Items in the DTR-QOL Questionnaire at the End of Study Stratified by the Number of Doses of the Study Drug or Comparative Drug (Once Weekly, Once Daily or Twice Daily) at Baseline</measure>
    <time_frame>Baseline (Week 0), up to the end of study (Week 12)</time_frame>
    <description>DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13 questions), Factor 2: Anxiety and dissatisfaction with treatment (8 questions), Factor 3: Hypoglycemia (4 questions) and Factor 4: Treatment satisfaction (4 questions). Each item is scored ranging from 1 to 7. Every score of the questions in Factor 1-3 and the score in Factor 4 converted into reverse (1-7 will be converted to 7-1) will be simply added up, and scores of each factor and the total figure will be subsequently converted from 0 to 100 (the best and worst scores will be equivalent to 100 and 0). Higher scores reflect better QOL and positive changes relative to baseline indicate improvement of QOL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Total Score for Questions About Treatment Satisfaction in the DTSQ at the End of Study Stratified by the Number of Doses of the Study Drug or Comparative Drug (Once Weekly, Once Daily or Twice Daily) at Baseline</measure>
    <time_frame>Baseline (Week 0), up to the end of study (Week 12)</time_frame>
    <description>The DTSQ is a self-reported instrument consists of 6 questions about treatment satisfaction and 2 questions regarding blood sugar level. Each question answered on a 7-point Likert scale from 0 to 6, based on concern with the diabetes treatment and experiences in the past few weeks. Higher total score for questions about treatment satisfaction indicate greater satisfaction with treatment and experiences.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study</measure>
    <time_frame>Baseline (Week 0), up to end of study (Week 12)</time_frame>
    <description>DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13 questions), Factor 2: Anxiety and dissatisfaction with treatment (8 questions), Factor 3: Hypoglycemia (4 questions) and Factor 4: Treatment satisfaction (4 questions). Each item is scored ranging from 1 to 7. Every score of the questions in Factor 1-3 and the score in Factor 4 converted into reverse (1-7 will be converted to 7-1) will be simply added up, and scores of each factor and the total figure will be subsequently converted from 0 to 100 (the best and worst scores will be equivalent to 100 and 0). Higher scores reflect better QOL and positive changes relative to baseline indicate improvement of QOL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Score Per Question in the the DTSQ at the End of Study</measure>
    <time_frame>Baseline (Week 0), up to end of study (Week 12)</time_frame>
    <description>The DTSQ is a self-reported instrument consists of 6 questions about treatment satisfaction and 2 questions regarding blood sugar level. Each question answered on a 7-point Likert scale from 0 to 6, based on concern with the diabetes treatment and experiences in the past few weeks. Higher total score for questions about treatment satisfaction indicate greater satisfaction with treatment and experiences.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Reporting One or More Treatment-emergent Adverse Events</measure>
    <time_frame>Up to 12 weeks</time_frame>
    <description>An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Reporting One or More Hypoglycemia</measure>
    <time_frame>Up to 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Hospitalization for Type 2 Diabetes (Excluding Educational Hospitalization Without Worsening of Diabetes)</measure>
    <time_frame>Up to 12 weeks</time_frame>
    <description>The investigators checked any hospitalization of study participants for type 2 diabetes after the first administration of the study drug or comparative drug (excluding educational hospitalization without worsening of diabetes).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Hospitalization for Type 2 Diabetes (Excluding Educational Hospitalization Without Worsening of Diabetes)</measure>
    <time_frame>Up to 12 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">219</enrollment>
  <condition>Type 2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Trelagliptin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Trelagliptin 100 mg, orally, once weekly for up to 12 weeks. Trelagliptin 50 mg, orally, once weekly for up to 12 weeks in patients with moderate renal impairment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Daily DPP-4 inhibitors</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Trelagliptin</intervention_name>
    <description>Trelagliptin 100 mg or 50 mg</description>
    <arm_group_label>Trelagliptin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Daily DPP-4 inhibitor</intervention_name>
    <description>Alogliptin, anagliptin, linagliptin, saxagliptin, sitagliptin, teneligliptin or vildagliptin</description>
    <arm_group_label>Daily DPP-4 inhibitors</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Participants diagnosed as type 2 diabetes.&#xD;
&#xD;
          2. Participants with a stable diet and exercise therapy only for at least 12 weeks prior&#xD;
             to the start of the screening period.&#xD;
&#xD;
          3. Participants who require a DPP-4 inhibitor treatment.&#xD;
&#xD;
          4. Participants with Hemoglobin A1c (HbA1c) &gt;=6.5 % and &lt;10.0 % at the start of the&#xD;
             screening period.&#xD;
&#xD;
          5. Participants who completed DTR-QOL questionnaire at the start of the screening period.&#xD;
&#xD;
          6. Participants who have received less than 2 types of medication for treatment of&#xD;
             comorbidities (such as hypertension or dyslipidemia) at the start of the screening&#xD;
             period (any number of daily doses).&#xD;
&#xD;
          7. Participants who, in the opinion of the principal investigator or the investigator,&#xD;
             are capable of understanding the content of the clinical study and complying with the&#xD;
             study protocol requirements.&#xD;
&#xD;
          8. Participants who can provide the written informed consent prior to the initiation of&#xD;
             any study procedures.&#xD;
&#xD;
          9. Participants aged &gt;=20 years at the time of informed consent.&#xD;
&#xD;
         10. Outpatient.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Participants who are receiving any oral anti-diabetic medication for the treatment of&#xD;
             type 2 diabetes at the start of the screening period.&#xD;
&#xD;
          2. Participants diagnosed with type 1 diabetes.&#xD;
&#xD;
          3. Participants with severe renal impairment or renal failure (e.g., estimated glomerular&#xD;
             filtration rate (eGFR) &lt;30 mL/min/1.73 m^2 or on dialysis).&#xD;
&#xD;
          4. Participants with serious heart disease or cerebrovascular disorder, or serious&#xD;
             pancreatic, blood, or other disease.&#xD;
&#xD;
          5. Participants with a history of gastrointestinal resection.&#xD;
&#xD;
          6. Participant with a proliferative diabetic retinopathy.&#xD;
&#xD;
          7. Participant with malignancy.&#xD;
&#xD;
          8. Participants with a history of hypersensitivity or allergy to DPP-4 inhibitors.&#xD;
&#xD;
          9. Pregnant, lactating or planning pregnancy during the study period.&#xD;
&#xD;
         10. Participants who may need to add or discontinue concomitant medication or change the&#xD;
             dose during the study period.&#xD;
&#xD;
         11. Participants who will require treatment with a prohibited concomitant medication&#xD;
             during the study period.&#xD;
&#xD;
         12. Participants participating in other clinical studies.&#xD;
&#xD;
         13. Participants assessed ineligible in the study by the principal investigator or the&#xD;
             investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Takeda</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Takeda Selected Site 17</name>
      <address>
        <city>Nagoya</city>
        <state>Aichi</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Takeda Selected Site 18</name>
      <address>
        <city>Nagoya</city>
        <state>Aichi</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Takeda Selected Site 25</name>
      <address>
        <city>Kanra</city>
        <state>Gunma</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Takeda Selected Site 9</name>
      <address>
        <city>Kobe</city>
        <state>Hyogo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Takeda Selected Site 27</name>
      <address>
        <city>Koga</city>
        <state>Ibaraki</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Takeda Selected Site 14</name>
      <address>
        <city>Kawasaki</city>
        <state>Kanagawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Takeda Selected Site 11</name>
      <address>
        <city>Sagamihara</city>
        <state>Kanagawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Takeda Selected Site 10</name>
      <address>
        <city>Yamato</city>
        <state>Kanagawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Takeda Selected Site 4</name>
      <address>
        <city>Sendai</city>
        <state>Miyagi</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Takeda Selected Site 5</name>
      <address>
        <city>Sendai</city>
        <state>Miyagi</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Takeda Selected Site 3</name>
      <address>
        <city>Kashihara</city>
        <state>Nara</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Takeda Selected Site 15</name>
      <address>
        <city>Kashiwara</city>
        <state>Osaka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Takeda Selected Site 1</name>
      <address>
        <city>Suita</city>
        <state>Osaka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Takeda Selected Site 24</name>
      <address>
        <city>Okegawa</city>
        <state>Saitama</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Takeda Selected Site 26</name>
      <address>
        <city>Oyama</city>
        <state>Tochigi</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Takeda Selected Site 23</name>
      <address>
        <city>Adachi-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Takeda Selected Site 6</name>
      <address>
        <city>Chuo-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Takeda Selected Site 7</name>
      <address>
        <city>Chuo-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Takeda Selected Site 22</name>
      <address>
        <city>Edogawa-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Takeda Selected Site 19</name>
      <address>
        <city>Musashino</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Takeda Selected Site 21</name>
      <address>
        <city>Ota-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Takeda Selected Site 12</name>
      <address>
        <city>Shibuya-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Takeda Selected Site 13</name>
      <address>
        <city>Shinagawa-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Takeda Selected Site 20</name>
      <address>
        <city>Shinagawa-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Takeda Selected Site 2</name>
      <address>
        <city>Shinjuku-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Takeda Selected Site 8</name>
      <address>
        <city>Shinjuku-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Takeda Selected Site 16</name>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 5, 2017</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <results_first_submitted>October 19, 2018</results_first_submitted>
  <results_first_submitted_qc>October 19, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">February 25, 2019</results_first_posted>
  <last_update_submitted>February 25, 2019</last_update_submitted>
  <last_update_submitted_qc>February 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <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>Dipeptidyl-Peptidase IV Inhibitors</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 for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 5, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/79/NCT03014479/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>December 28, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/79/NCT03014479/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants took part in the study at 25 investigative sites in Japan, from 18 February 2017 to 21 October 2017.</recruitment_details>
      <pre_assignment_details>Participants with a historical diagnosis of type 2 diabetes mellitus on diet and exercise therapy only, were enrolled in 1 of 2 treatment groups (Trelagliptin once-weekly, or the Daily DPP-4 inhibitor once- or twice-daily (according to individual label instructions), orally, for up to 12 weeks).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Trelagliptin</title>
          <description>Trelagliptin 100 mg, orally, once weekly for up to 12 weeks. Trelagliptin 50 mg, orally, once weekly for up to 12 weeks in patients with moderate renal impairment.</description>
        </group>
        <group group_id="P2">
          <title>Daily DPP-4 Inhibitors</title>
          <description>An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="110"/>
                <participants group_id="P2" count="109"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="110"/>
                <participants group_id="P2" count="105"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Voluntary Withdrawal</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Unacceptable Inability of Site Visit</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Full Analysis Set (FAS): All participants who were randomized and received at least 1 dose of the study drug for the treatment period.</population>
      <group_list>
        <group group_id="B1">
          <title>Trelagliptin</title>
          <description>Trelagliptin 100 mg, orally, once weekly for up to 12 weeks. Trelagliptin 50 mg, orally, once weekly for up to 12 weeks in patients with moderate renal impairment.</description>
        </group>
        <group group_id="B2">
          <title>Daily DPP-4 Inhibitors</title>
          <description>An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="110"/>
            <count group_id="B2" value="108"/>
            <count group_id="B3" value="218"/>
          </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="110"/>
                    <count group_id="B2" value="108"/>
                    <count group_id="B3" value="218"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61.5" spread="8.96"/>
                    <measurement group_id="B2" value="58.4" spread="10.01"/>
                    <measurement group_id="B3" value="59.9" spread="9.60"/>
                  </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="110"/>
                    <count group_id="B2" value="108"/>
                    <count group_id="B3" value="218"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="86"/>
                    <measurement group_id="B2" value="82"/>
                    <measurement group_id="B3" value="168"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Japan</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="110"/>
                    <count group_id="B2" value="108"/>
                    <count group_id="B3" value="218"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="110"/>
                    <measurement group_id="B2" value="108"/>
                    <measurement group_id="B3" value="218"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>Centimeter (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="110"/>
                    <count group_id="B2" value="108"/>
                    <count group_id="B3" value="218"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="165.0" spread="9.56"/>
                    <measurement group_id="B2" value="165.6" spread="9.29"/>
                    <measurement group_id="B3" value="165.3" spread="9.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>Kilogram (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="110"/>
                    <count group_id="B2" value="108"/>
                    <count group_id="B3" value="218"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67.57" spread="11.917"/>
                    <measurement group_id="B2" value="70.51" spread="15.707"/>
                    <measurement group_id="B3" value="69.03" spread="13.969"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <description>Body Mass Index = weight (kg)/[height (m)^2]</description>
          <units>Kilogram per square meter (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="110"/>
                    <count group_id="B2" value="108"/>
                    <count group_id="B3" value="218"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.72" spread="3.224"/>
                    <measurement group_id="B2" value="25.53" spread="4.349"/>
                    <measurement group_id="B3" value="25.12" spread="3.836"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Smoking Classification</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="110"/>
                    <count group_id="B2" value="108"/>
                    <count group_id="B3" value="218"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Never smoked</title>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="88"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Current smoker</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="52"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Ex-smoker</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Alcohol Classification</title>
          <description>Participants who answered Yes or No for a question &quot;Drink Alcohol Almost Every Day?&quot; were reported.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="110"/>
                    <count group_id="B2" value="108"/>
                    <count group_id="B3" value="218"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="74"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="72"/>
                    <measurement group_id="B2" value="72"/>
                    <measurement group_id="B3" value="144"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration of type 2 diabetes mellitus</title>
          <description>Mean duration between start of study and first time of diagnosis of type 2 diabetes mellitus was reported.</description>
          <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="110"/>
                    <count group_id="B2" value="108"/>
                    <count group_id="B3" value="218"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.45" spread="4.972"/>
                    <measurement group_id="B2" value="6.39" spread="5.286"/>
                    <measurement group_id="B3" value="6.42" spread="5.118"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Any Medication for Concurrent Condition</title>
          <description>Number of participants who received any medication for concurrent condition was reported.</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="110"/>
                    <count group_id="B2" value="108"/>
                    <count group_id="B3" value="218"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Had Any Medication</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="91"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Had No Any Medication</title>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                    <measurement group_id="B2" value="67"/>
                    <measurement group_id="B3" value="127"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Daily Doses of Medication (Concurrent Condition Medicine.)</title>
          <population>The baseline characteristic was analyzed in participants who had any medication for concurrent condition.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="50"/>
                    <count group_id="B2" value="41"/>
                    <count group_id="B3" value="91"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Less than (&lt;) 2 Times</title>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="85"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Greater than or Equal to (≥) 2 Times</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Total Number of Daily Tablets (Concurrent Condition Medicine.)</title>
          <population>The baseline characteristic was analyzed in participants who had any medication for concurrent condition.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="50"/>
                    <count group_id="B2" value="41"/>
                    <count group_id="B3" value="91"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;2 Tablets</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="82"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥2 Tablets</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Doses of Drugs (Study drug.)</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="110"/>
                    <count group_id="B2" value="108"/>
                    <count group_id="B3" value="218"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Once a Week</title>
                  <measurement_list>
                    <measurement group_id="B1" value="110"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="110"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Once daily</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="100"/>
                    <measurement group_id="B3" value="100"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Twice daily</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Glycated hemoglobin A1c (HbA1c)</title>
          <units>Percent</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="110"/>
                    <count group_id="B2" value="108"/>
                    <count group_id="B3" value="218"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.37" spread="0.730"/>
                    <measurement group_id="B2" value="7.37" spread="0.624"/>
                    <measurement group_id="B3" value="7.37" spread="0.678"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>DTR-QOL Total Score at Week-4</title>
          <description>DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL including 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13; number of questions), Factor 2: Anxiety and dissatisfaction with treatment (8), Factor 3: Hypoglycemia (4) and Factor 4: Treatment satisfaction (4). Each item is scored ranging from 1 to 7 and will be added up, and summed scores will be converted from 0 (worst) to 100 (best). Higher scores reflect better QOL and positive changes from baseline indicate improvement of QOL.</description>
          <units>Units on a Scale</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="110"/>
                    <count group_id="B2" value="108"/>
                    <count group_id="B3" value="218"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="66.41" spread="15.934"/>
                    <measurement group_id="B2" value="66.37" spread="14.725"/>
                    <measurement group_id="B3" value="66.39" spread="15.311"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>DTR-QOL Total Score at Week 0</title>
          <description>DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL including 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13; number of questions), Factor 2: Anxiety and dissatisfaction with treatment (8), Factor 3: Hypoglycemia (4) and Factor 4: Treatment satisfaction (4). Each item is scored ranging from 1 to 7 and will be added up, and summed scores will be converted from 0 (worst) to 100 (best). Higher scores reflect better QOL and positive changes from baseline indicate improvement of QOL.</description>
          <units>Units on a Scale</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="110"/>
                    <count group_id="B2" value="108"/>
                    <count group_id="B3" value="218"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="68.48" spread="17.158"/>
                    <measurement group_id="B2" value="68.86" spread="16.240"/>
                    <measurement group_id="B3" value="68.67" spread="16.673"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>DTR-QOL Total Score; Factor 1 at Week 0</title>
          <description>DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL including 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13; number of questions), Factor 2: Anxiety and dissatisfaction with treatment (8), Factor 3: Hypoglycemia (4) and Factor 4: Treatment satisfaction (4). Each item is scored ranging from 1 to 7 and will be added up, and summed scores will be converted from 0 (worst) to 100 (best). Higher scores reflect better QOL and positive changes from baseline indicate improvement of QOL.</description>
          <units>Units on a Scale</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="110"/>
                    <count group_id="B2" value="108"/>
                    <count group_id="B3" value="218"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="73.31" spread="20.934"/>
                    <measurement group_id="B2" value="73.48" spread="20.060"/>
                    <measurement group_id="B3" value="73.39" spread="20.459"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>DTR-QOL Total Score; Factor 2 at Week 0</title>
          <description>DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL including 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13; number of questions), Factor 2: Anxiety and dissatisfaction with treatment (8), Factor 3: Hypoglycemia (4) and Factor 4: Treatment satisfaction (4). Each item is scored ranging from 1 to 7 and will be added up, and summed scores will be converted from 0 (worst) to 100 (best). Higher scores reflect better QOL and positive changes from baseline indicate improvement of QOL.</description>
          <units>Units on a Scale</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="110"/>
                    <count group_id="B2" value="108"/>
                    <count group_id="B3" value="218"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62.94" spread="20.334"/>
                    <measurement group_id="B2" value="65.10" spread="19.725"/>
                    <measurement group_id="B3" value="64.01" spread="20.018"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>DTR-QOL Total Score; Factor 3 at Week 0</title>
          <description>DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL including 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13; number of questions), Factor 2: Anxiety and dissatisfaction with treatment (8), Factor 3: Hypoglycemia (4) and Factor 4: Treatment satisfaction (4). Each item is scored ranging from 1 to 7 and will be added up, and summed scores will be converted from 0 (worst) to 100 (best). Higher scores reflect better QOL and positive changes from baseline indicate improvement of QOL.</description>
          <units>Units on a Scale</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="110"/>
                    <count group_id="B2" value="108"/>
                    <count group_id="B3" value="218"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="79.13" spread="24.721"/>
                    <measurement group_id="B2" value="78.97" spread="23.254"/>
                    <measurement group_id="B3" value="79.05" spread="23.950"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>DTR-QOL Total Score; Factor 4 at Week 0</title>
          <description>DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL including 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13; number of questions), Factor 2: Anxiety and dissatisfaction with treatment (8), Factor 3: Hypoglycemia (4) and Factor 4: Treatment satisfaction (4). Each item is scored ranging from 1 to 7 and will be added up, and summed scores will be converted from 0 (worst) to 100 (best). Higher scores reflect better QOL and positive changes from baseline indicate improvement of QOL.</description>
          <units>Units on a Scale</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="110"/>
                    <count group_id="B2" value="108"/>
                    <count group_id="B3" value="218"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53.22" spread="16.539"/>
                    <measurement group_id="B2" value="51.27" spread="16.347"/>
                    <measurement group_id="B3" value="52.26" spread="16.435"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>DTSQ Total score</title>
          <description>The DTSQ is a self-reported instrument consists of 6 questions about treatment satisfaction and 2 questions regarding blood sugar level. Each question answered on a 7-point Likert scale from 0 to 6, based on concern with the diabetes treatment and experiences in the past few weeks. Higher total score for questions about treatment satisfaction indicate greater satisfaction with treatment and experiences.</description>
          <population>The number analyzed is the number of participants with data available for analysis.</population>
          <units>Units on a Scale</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="108"/>
                    <count group_id="B2" value="108"/>
                    <count group_id="B3" value="216"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22.31" spread="5.444"/>
                    <measurement group_id="B2" value="21.56" spread="5.679"/>
                    <measurement group_id="B3" value="21.94" spread="5.562"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Total Score for All Question Items in the Diabetes Therapy Related -QOL (DTR-QOL) Questionnaire at the End of Study</title>
        <description>DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13 questions), Factor 2: Anxiety and dissatisfaction with treatment (8 questions), Factor 3: Hypoglycemia (4 questions) and Factor 4: Treatment satisfaction (4 questions). Each item is scored ranging from 1 to 7. Every score of the questions in Factor 1-3 and the score in Factor 4 converted into reverse (1-7 will be converted to 7-1) will be simply added up, and scores of each factor and the total figure will be subsequently converted from 0 to 100 (the best and worst scores will be equivalent to 100 and 0). Higher scores reflect better QOL and positive changes relative to baseline indicate improvement of QOL.</description>
        <time_frame>Baseline (Week 0), up to the end of study (Week 12)</time_frame>
        <population>Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Trelagliptin</title>
            <description>Trelagliptin 100 mg, orally, once weekly for up to 12 weeks. Trelagliptin 50 mg, orally, once weekly for up to 12 weeks in patients with moderate renal impairment.</description>
          </group>
          <group group_id="O2">
            <title>Daily DPP-4 Inhibitors</title>
            <description>An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Total Score for All Question Items in the Diabetes Therapy Related -QOL (DTR-QOL) Questionnaire at the End of Study</title>
          <description>DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13 questions), Factor 2: Anxiety and dissatisfaction with treatment (8 questions), Factor 3: Hypoglycemia (4 questions) and Factor 4: Treatment satisfaction (4 questions). Each item is scored ranging from 1 to 7. Every score of the questions in Factor 1-3 and the score in Factor 4 converted into reverse (1-7 will be converted to 7-1) will be simply added up, and scores of each factor and the total figure will be subsequently converted from 0 to 100 (the best and worst scores will be equivalent to 100 and 0). Higher scores reflect better QOL and positive changes relative to baseline indicate improvement of QOL.</description>
          <population>Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.</population>
          <units>Units on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="110"/>
                <count group_id="O2" value="108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.72" spread="16.162"/>
                    <measurement group_id="O2" value="6.35" spread="14.093"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2305</p_value>
            <method>ANCOVA</method>
            <param_type>Differences of Least Square Means</param_type>
            <param_value>2.418</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.546</ci_lower_limit>
            <ci_upper_limit>6.382</ci_upper_limit>
            <estimate_desc>Trelagliptin - Daily DPP-4 inhibitors</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Total Score for Each Factor Provided Through the DTR-QOL Questionnaire [Factor 1: Burden on Social Activities and Daily Activities] at Each Assessment Time Point</title>
        <description>DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13 questions), Factor 2: Anxiety and dissatisfaction with treatment (8 questions), Factor 3: Hypoglycemia (4 questions) and Factor 4: Treatment satisfaction (4 questions). Each item is scored ranging from 1 to 7. Every score of the questions in Factor 1-3 and the score in Factor 4 converted into reverse (1-7 will be converted to 7-1) will be simply added up, and scores of each factor and the total figure will be subsequently converted from 0 to 100 (the best and worst scores will be equivalent to 100 and 0). Higher scores reflect better QOL and positive changes relative to baseline indicate improvement of QOL.</description>
        <time_frame>Baseline (Week 0), up to Week 4, 12, and the end of study (Week 12)</time_frame>
        <population>Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.</population>
        <group_list>
          <group group_id="O1">
            <title>Trelagliptin</title>
            <description>Trelagliptin 100 mg, orally, once weekly for up to 12 weeks. Trelagliptin 50 mg, orally, once weekly for up to 12 weeks in patients with moderate renal impairment.</description>
          </group>
          <group group_id="O2">
            <title>Daily DPP-4 Inhibitors</title>
            <description>An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Total Score for Each Factor Provided Through the DTR-QOL Questionnaire [Factor 1: Burden on Social Activities and Daily Activities] at Each Assessment Time Point</title>
          <description>DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13 questions), Factor 2: Anxiety and dissatisfaction with treatment (8 questions), Factor 3: Hypoglycemia (4 questions) and Factor 4: Treatment satisfaction (4 questions). Each item is scored ranging from 1 to 7. Every score of the questions in Factor 1-3 and the score in Factor 4 converted into reverse (1-7 will be converted to 7-1) will be simply added up, and scores of each factor and the total figure will be subsequently converted from 0 to 100 (the best and worst scores will be equivalent to 100 and 0). Higher scores reflect better QOL and positive changes relative to baseline indicate improvement of QOL.</description>
          <population>Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.</population>
          <units>Units on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="110"/>
                <count group_id="O2" value="108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="109"/>
                    <count group_id="O2" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.24" spread="18.200"/>
                    <measurement group_id="O2" value="7.83" spread="19.426"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="109"/>
                    <count group_id="O2" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.98" spread="20.116"/>
                    <measurement group_id="O2" value="9.12" spread="18.560"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of Study</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="110"/>
                    <count group_id="O2" value="108"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.79" spread="20.126"/>
                    <measurement group_id="O2" value="8.92" spread="19.048"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4536</p_value>
            <method>ANCOVA</method>
            <param_type>Differences of Least Square Means</param_type>
            <param_value>1.938</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.150</ci_lower_limit>
            <ci_upper_limit>7.027</ci_upper_limit>
            <estimate_desc>Trelagliptin - Daily DPP-4 inhibitors</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Total Score for Each Factor Provided Through the DTR-QOL Questionnaire [Factor 2: Anxiety and Dissatisfaction With Treatments] at Each Assessment Time Point</title>
        <description>DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13 questions), Factor 2: Anxiety and dissatisfaction with treatment (8 questions), Factor 3: Hypoglycemia (4 questions) and Factor 4: Treatment satisfaction (4 questions). Each item is scored ranging from 1 to 7. Every score of the questions in Factor 1-3 and the score in Factor 4 converted into reverse (1-7 will be converted to 7-1) will be simply added up, and scores of each factor and the total figure will be subsequently converted from 0 to 100 (the best and worst scores will be equivalent to 100 and 0). Higher scores reflect better QOL and positive changes relative to baseline indicate improvement of QOL.</description>
        <time_frame>Baseline (Week 0), up to Week 4, 12, and the end of study (Week 12)</time_frame>
        <population>Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.</population>
        <group_list>
          <group group_id="O1">
            <title>Trelagliptin</title>
            <description>Trelagliptin 100 mg, orally, once weekly for up to 12 weeks. Trelagliptin 50 mg, orally, once weekly for up to 12 weeks in patients with moderate renal impairment.</description>
          </group>
          <group group_id="O2">
            <title>Daily DPP-4 Inhibitors</title>
            <description>An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Total Score for Each Factor Provided Through the DTR-QOL Questionnaire [Factor 2: Anxiety and Dissatisfaction With Treatments] at Each Assessment Time Point</title>
          <description>DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13 questions), Factor 2: Anxiety and dissatisfaction with treatment (8 questions), Factor 3: Hypoglycemia (4 questions) and Factor 4: Treatment satisfaction (4 questions). Each item is scored ranging from 1 to 7. Every score of the questions in Factor 1-3 and the score in Factor 4 converted into reverse (1-7 will be converted to 7-1) will be simply added up, and scores of each factor and the total figure will be subsequently converted from 0 to 100 (the best and worst scores will be equivalent to 100 and 0). Higher scores reflect better QOL and positive changes relative to baseline indicate improvement of QOL.</description>
          <population>Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.</population>
          <units>Units on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="110"/>
                <count group_id="O2" value="108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="109"/>
                    <count group_id="O2" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.18" spread="14.925"/>
                    <measurement group_id="O2" value="0.39" spread="13.769"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="109"/>
                    <count group_id="O2" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.94" spread="18.577"/>
                    <measurement group_id="O2" value="2.18" spread="17.498"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of Study</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="110"/>
                    <count group_id="O2" value="108"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.23" spread="18.735"/>
                    <measurement group_id="O2" value="2.10" spread="17.315"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0896</p_value>
            <method>ANCOVA</method>
            <param_type>Differences of Least Square Means</param_type>
            <param_value>4.160</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.649</ci_lower_limit>
            <ci_upper_limit>8.968</ci_upper_limit>
            <estimate_desc>Trelagliptin - Daily DPP-4 inhibitors</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Total Score for Each Factor Provided Through the DTR-QOL Questionnaire [Factor 3: Hypoglycemia] at Each Assessment Time Point</title>
        <description>DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13 questions), Factor 2: Anxiety and dissatisfaction with treatment (8 questions), Factor 3: Hypoglycemia (4 questions) and Factor 4: Treatment satisfaction (4 questions). Each item is scored ranging from 1 to 7. Every score of the questions in Factor 1-3 and the score in Factor 4 converted into reverse (1-7 will be converted to 7-1) will be simply added up, and scores of each factor and the total figure will be subsequently converted from 0 to 100 (the best and worst scores will be equivalent to 100 and 0). Higher scores reflect better QOL and positive changes relative to baseline indicate improvement of QOL.</description>
        <time_frame>Baseline (Week 0), up to Week 4, 12, and the end of study (Week 12)</time_frame>
        <population>Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.</population>
        <group_list>
          <group group_id="O1">
            <title>Trelagliptin</title>
            <description>Trelagliptin 100 mg, orally, once weekly for up to 12 weeks. Trelagliptin 50 mg, orally, once weekly for up to 12 weeks in patients with moderate renal impairment.</description>
          </group>
          <group group_id="O2">
            <title>Daily DPP-4 Inhibitors</title>
            <description>An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Total Score for Each Factor Provided Through the DTR-QOL Questionnaire [Factor 3: Hypoglycemia] at Each Assessment Time Point</title>
          <description>DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13 questions), Factor 2: Anxiety and dissatisfaction with treatment (8 questions), Factor 3: Hypoglycemia (4 questions) and Factor 4: Treatment satisfaction (4 questions). Each item is scored ranging from 1 to 7. Every score of the questions in Factor 1-3 and the score in Factor 4 converted into reverse (1-7 will be converted to 7-1) will be simply added up, and scores of each factor and the total figure will be subsequently converted from 0 to 100 (the best and worst scores will be equivalent to 100 and 0). Higher scores reflect better QOL and positive changes relative to baseline indicate improvement of QOL.</description>
          <population>Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.</population>
          <units>Units on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="110"/>
                <count group_id="O2" value="108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="109"/>
                    <count group_id="O2" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.15" spread="23.155"/>
                    <measurement group_id="O2" value="4.87" spread="22.298"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="109"/>
                    <count group_id="O2" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.85" spread="22.837"/>
                    <measurement group_id="O2" value="7.38" spread="21.224"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of Study</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="110"/>
                    <count group_id="O2" value="108"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.06" spread="22.840"/>
                    <measurement group_id="O2" value="6.67" spread="21.586"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8506</p_value>
            <method>ANCOVA</method>
            <param_type>Differences of Least Square Means</param_type>
            <param_value>-0.563</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.448</ci_lower_limit>
            <ci_upper_limit>5.323</ci_upper_limit>
            <estimate_desc>Trelagliptin - Daily DPP-4 inhibitors</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Total Score for Each Factor Provided Through the DTR-QOL Questionnaire [Factor 4: Satisfaction With Treatment] at Each Assessment Time Point</title>
        <description>DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13 questions), Factor 2: Anxiety and dissatisfaction with treatment (8 questions), Factor 3: Hypoglycemia (4 questions) and Factor 4: Treatment satisfaction (4 questions). Each item is scored ranging from 1 to 7. Every score of the questions in Factor 1-3 and the score in Factor 4 converted into reverse (1-7 will be converted to 7-1) will be simply added up, and scores of each factor and the total figure will be subsequently converted from 0 to 100 (the best and worst scores will be equivalent to 100 and 0). Higher scores reflect better QOL and positive changes relative to baseline indicate improvement of QOL.</description>
        <time_frame>Baseline (Week 0), up to Week 4, 12, and the end of study (Week 12)</time_frame>
        <population>Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.</population>
        <group_list>
          <group group_id="O1">
            <title>Trelagliptin</title>
            <description>Trelagliptin 100 mg, orally, once weekly for up to 12 weeks. Trelagliptin 50 mg, orally, once weekly for up to 12 weeks in patients with moderate renal impairment.</description>
          </group>
          <group group_id="O2">
            <title>Daily DPP-4 Inhibitors</title>
            <description>An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Total Score for Each Factor Provided Through the DTR-QOL Questionnaire [Factor 4: Satisfaction With Treatment] at Each Assessment Time Point</title>
          <description>DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13 questions), Factor 2: Anxiety and dissatisfaction with treatment (8 questions), Factor 3: Hypoglycemia (4 questions) and Factor 4: Treatment satisfaction (4 questions). Each item is scored ranging from 1 to 7. Every score of the questions in Factor 1-3 and the score in Factor 4 converted into reverse (1-7 will be converted to 7-1) will be simply added up, and scores of each factor and the total figure will be subsequently converted from 0 to 100 (the best and worst scores will be equivalent to 100 and 0). Higher scores reflect better QOL and positive changes relative to baseline indicate improvement of QOL.</description>
          <population>Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.</population>
          <units>Units on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="110"/>
                <count group_id="O2" value="108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="109"/>
                    <count group_id="O2" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.24" spread="22.254"/>
                    <measurement group_id="O2" value="3.85" spread="17.143"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="108"/>
                    <count group_id="O2" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.53" spread="23.607"/>
                    <measurement group_id="O2" value="6.71" spread="18.431"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of Study</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="110"/>
                    <count group_id="O2" value="108"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.86" spread="23.806"/>
                    <measurement group_id="O2" value="6.17" spread="18.507"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3533</p_value>
            <method>ANCOVA</method>
            <param_type>Differences of Least Square Means</param_type>
            <param_value>2.696</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.018</ci_lower_limit>
            <ci_upper_limit>8.410</ci_upper_limit>
            <estimate_desc>Trelagliptin - Daily DPP-4 inhibitors</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Total Score for All Question Items in the DTR-QOL Questionnaire at Each Assessment Time Point</title>
        <description>DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13 questions), Factor 2: Anxiety and dissatisfaction with treatment (8 questions), Factor 3: Hypoglycemia (4 questions) and Factor 4: Treatment satisfaction (4 questions). Each item is scored ranging from 1 to 7. Every score of the questions in Factor 1-3 and the score in Factor 4 converted into reverse (1-7 will be converted to 7-1) will be simply added up, and scores of each factor and the total figure will be subsequently converted from 0 to 100 (the best and worst scores will be equivalent to 100 and 0). Higher scores reflect better QOL and positive changes relative to baseline indicate improvement of QOL.</description>
        <time_frame>Baseline (Week 0), up to Week 4, 12</time_frame>
        <population>Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.</population>
        <group_list>
          <group group_id="O1">
            <title>Trelagliptin</title>
            <description>Trelagliptin 100 mg, orally, once weekly for up to 12 weeks. Trelagliptin 50 mg, orally, once weekly for up to 12 weeks in patients with moderate renal impairment.</description>
          </group>
          <group group_id="O2">
            <title>Daily DPP-4 Inhibitors</title>
            <description>An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Total Score for All Question Items in the DTR-QOL Questionnaire at Each Assessment Time Point</title>
          <description>DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13 questions), Factor 2: Anxiety and dissatisfaction with treatment (8 questions), Factor 3: Hypoglycemia (4 questions) and Factor 4: Treatment satisfaction (4 questions). Each item is scored ranging from 1 to 7. Every score of the questions in Factor 1-3 and the score in Factor 4 converted into reverse (1-7 will be converted to 7-1) will be simply added up, and scores of each factor and the total figure will be subsequently converted from 0 to 100 (the best and worst scores will be equivalent to 100 and 0). Higher scores reflect better QOL and positive changes relative to baseline indicate improvement of QOL.</description>
          <population>Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.</population>
          <units>Units on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="110"/>
                <count group_id="O2" value="108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="109"/>
                    <count group_id="O2" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.04" spread="13.111"/>
                    <measurement group_id="O2" value="4.82" spread="12.776"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="108"/>
                    <count group_id="O2" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.58" spread="16.280"/>
                    <measurement group_id="O2" value="6.63" spread="14.046"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Total Score for Questions About Treatment Satisfaction in the Diabetes Treatment Satisfaction Questionnaire (DTSQ) at Each Assessment Time Point</title>
        <description>The DTSQ is a self-reported instrument consists of 6 questions about treatment satisfaction and 2 questions regarding blood sugar level. Each question answered on a 7-point Likert scale from 0 to 6, based on concern with the diabetes treatment and experiences in the past few weeks. Higher total score for questions about treatment satisfaction indicate greater satisfaction with treatment and experiences.</description>
        <time_frame>Baseline (Week 0), up to Week 4, 12 and the end of study (Week 12)</time_frame>
        <population>Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.</population>
        <group_list>
          <group group_id="O1">
            <title>Trelagliptin</title>
            <description>Trelagliptin 100 mg, orally, once weekly for up to 12 weeks. Trelagliptin 50 mg, orally, once weekly for up to 12 weeks in patients with moderate renal impairment.</description>
          </group>
          <group group_id="O2">
            <title>Daily DPP-4 Inhibitors</title>
            <description>An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Total Score for Questions About Treatment Satisfaction in the Diabetes Treatment Satisfaction Questionnaire (DTSQ) at Each Assessment Time Point</title>
          <description>The DTSQ is a self-reported instrument consists of 6 questions about treatment satisfaction and 2 questions regarding blood sugar level. Each question answered on a 7-point Likert scale from 0 to 6, based on concern with the diabetes treatment and experiences in the past few weeks. Higher total score for questions about treatment satisfaction indicate greater satisfaction with treatment and experiences.</description>
          <population>Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.</population>
          <units>Units on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="110"/>
                <count group_id="O2" value="108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="108"/>
                    <count group_id="O2" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" spread="6.35"/>
                    <measurement group_id="O2" value="1.7" spread="6.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" spread="7.59"/>
                    <measurement group_id="O2" value="2.9" spread="6.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of Study</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="108"/>
                    <count group_id="O2" value="108"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" spread="7.59"/>
                    <measurement group_id="O2" value="2.5" spread="7.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5451</p_value>
            <method>ANCOVA</method>
            <param_type>Differences of Least Square Means</param_type>
            <param_value>0.613</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.380</ci_lower_limit>
            <ci_upper_limit>2.605</ci_upper_limit>
            <estimate_desc>Trelagliptin - Daily DPP-4 inhibitors</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Total Score for All Question Items in the DTR-QOL Questionnaire at the End of Study Stratified by the Use of Medication for Treatment of Comorbidities at Baseline</title>
        <description>DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13 questions), Factor 2: Anxiety and dissatisfaction with treatment (8 questions), Factor 3: Hypoglycemia (4 questions) and Factor 4: Treatment satisfaction (4 questions). Each item is scored ranging from 1 to 7. Every score of the questions in Factor 1-3 and the score in Factor 4 converted into reverse (1-7 will be converted to 7-1) will be simply added up, and scores of each factor and the total figure will be subsequently converted from 0 to 100 (the best and worst scores will be equivalent to 100 and 0). Higher scores reflect better QOL and positive changes relative to baseline indicate improvement of QOL. Reported data was the score stratified by the use of medication for treatment of comorbidities at baseline (Used/ Not used).</description>
        <time_frame>Baseline (Week 0), up to the end of study (Week 12)</time_frame>
        <population>Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Trelagliptin</title>
            <description>Trelagliptin 100 mg, orally, once weekly for up to 12 weeks. Trelagliptin 50 mg, orally, once weekly for up to 12 weeks in patients with moderate renal impairment.</description>
          </group>
          <group group_id="O2">
            <title>Daily DPP-4 Inhibitors</title>
            <description>An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Total Score for All Question Items in the DTR-QOL Questionnaire at the End of Study Stratified by the Use of Medication for Treatment of Comorbidities at Baseline</title>
          <description>DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13 questions), Factor 2: Anxiety and dissatisfaction with treatment (8 questions), Factor 3: Hypoglycemia (4 questions) and Factor 4: Treatment satisfaction (4 questions). Each item is scored ranging from 1 to 7. Every score of the questions in Factor 1-3 and the score in Factor 4 converted into reverse (1-7 will be converted to 7-1) will be simply added up, and scores of each factor and the total figure will be subsequently converted from 0 to 100 (the best and worst scores will be equivalent to 100 and 0). Higher scores reflect better QOL and positive changes relative to baseline indicate improvement of QOL. Reported data was the score stratified by the use of medication for treatment of comorbidities at baseline (Used/ Not used).</description>
          <population>Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.</population>
          <units>Units on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="110"/>
                <count group_id="O2" value="108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Used</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.46" spread="15.728"/>
                    <measurement group_id="O2" value="5.80" spread="11.364"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not used</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="67"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.60" spread="16.408"/>
                    <measurement group_id="O2" value="6.68" spread="15.603"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Total Score for Questions About Treatment Satisfaction in the DTSQ at the End of Study Stratified by the Use of Medication for Treatment of Comorbidities at Baseline</title>
        <description>The DTSQ is a self-reported instrument consists of 6 questions about treatment satisfaction and 2 questions regarding blood sugar level. Each question answered on a 7-point Likert scale from 0 to 6, based on concern with the diabetes treatment and experiences in the past few weeks. Higher total score for questions about treatment satisfaction indicate greater satisfaction with treatment and experiences. Reported data was the score stratified by the use of medication for treatment of comorbidities at baseline (Used/ Not used).</description>
        <time_frame>Baseline (Week 0), up to the end of study (Week 12)</time_frame>
        <population>Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Trelagliptin</title>
            <description>Trelagliptin 100 mg, orally, once weekly for up to 12 weeks. Trelagliptin 50 mg, orally, once weekly for up to 12 weeks in patients with moderate renal impairment.</description>
          </group>
          <group group_id="O2">
            <title>Daily DPP-4 Inhibitors</title>
            <description>An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Total Score for Questions About Treatment Satisfaction in the DTSQ at the End of Study Stratified by the Use of Medication for Treatment of Comorbidities at Baseline</title>
          <description>The DTSQ is a self-reported instrument consists of 6 questions about treatment satisfaction and 2 questions regarding blood sugar level. Each question answered on a 7-point Likert scale from 0 to 6, based on concern with the diabetes treatment and experiences in the past few weeks. Higher total score for questions about treatment satisfaction indicate greater satisfaction with treatment and experiences. Reported data was the score stratified by the use of medication for treatment of comorbidities at baseline (Used/ Not used).</description>
          <population>Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis.</population>
          <units>Units on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="108"/>
                <count group_id="O2" value="108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Used</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" spread="8.44"/>
                    <measurement group_id="O2" value="1.2" spread="4.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not used</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="58"/>
                    <count group_id="O2" value="67"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.3" spread="6.61"/>
                    <measurement group_id="O2" value="3.3" spread="8.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Total Score for All Question Items in the DTR-QOL Questionnaire at the End of Study Stratified by the Number of Daily Doses of Medication for Treatment of Comorbidities (&lt;2 Times or ≥2 Times) at Baseline</title>
        <description>DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13 questions), Factor 2: Anxiety and dissatisfaction with treatment (8 questions), Factor 3: Hypoglycemia (4 questions) and Factor 4: Treatment satisfaction (4 questions). Each item is scored ranging from 1 to 7. Every score of the questions in Factor 1-3 and the score in Factor 4 converted into reverse (1-7 will be converted to 7-1) will be simply added up, and scores of each factor and the total figure will be subsequently converted from 0 to 100 (the best and worst scores will be equivalent to 100 and 0). Higher scores reflect better QOL and positive changes relative to baseline indicate improvement of QOL.</description>
        <time_frame>Baseline (Week 0), up to the end of study (Week 12)</time_frame>
        <population>Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. This outcome measure was analyzed with FAS in participants who had any medication for concurrent condition at baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>Trelagliptin</title>
            <description>Trelagliptin 100 mg, orally, once weekly for up to 12 weeks. Trelagliptin 50 mg, orally, once weekly for up to 12 weeks in patients with moderate renal impairment.</description>
          </group>
          <group group_id="O2">
            <title>Daily DPP-4 Inhibitors</title>
            <description>An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Total Score for All Question Items in the DTR-QOL Questionnaire at the End of Study Stratified by the Number of Daily Doses of Medication for Treatment of Comorbidities (&lt;2 Times or ≥2 Times) at Baseline</title>
          <description>DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13 questions), Factor 2: Anxiety and dissatisfaction with treatment (8 questions), Factor 3: Hypoglycemia (4 questions) and Factor 4: Treatment satisfaction (4 questions). Each item is scored ranging from 1 to 7. Every score of the questions in Factor 1-3 and the score in Factor 4 converted into reverse (1-7 will be converted to 7-1) will be simply added up, and scores of each factor and the total figure will be subsequently converted from 0 to 100 (the best and worst scores will be equivalent to 100 and 0). Higher scores reflect better QOL and positive changes relative to baseline indicate improvement of QOL.</description>
          <population>Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. This outcome measure was analyzed with FAS in participants who had any medication for concurrent condition at baseline.</population>
          <units>Units on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>&lt;2 times</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.26" spread="16.035"/>
                    <measurement group_id="O2" value="5.57" spread="11.519"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥2 times</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.76" spread="13.259"/>
                    <measurement group_id="O2" value="10.34" spread="8.940"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Total Score for Questions About Treatment Satisfaction in the DTSQ at the End of Study Stratified by the Number of Daily Doses of Medication for Treatment of Comorbidities (&lt;2 Times or ≥2 Times) at Baseline</title>
        <description>The DTSQ is a self-reported instrument consists of 6 questions about treatment satisfaction and 2 questions regarding blood sugar level. Each question answered on a 7-point Likert scale from 0 to 6, based on concern with the diabetes treatment and experiences in the past few weeks. Higher total score for questions about treatment satisfaction indicate greater satisfaction with treatment and experiences.</description>
        <time_frame>Baseline (Week 0), up to the end of study (Week 12)</time_frame>
        <population>Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. This outcome measure was analyzed with FAS in participants who had any medication for concurrent condition at baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>Trelagliptin</title>
            <description>Trelagliptin 100 mg, orally, once weekly for up to 12 weeks. Trelagliptin 50 mg, orally, once weekly for up to 12 weeks in patients with moderate renal impairment.</description>
          </group>
          <group group_id="O2">
            <title>Daily DPP-4 Inhibitors</title>
            <description>An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Total Score for Questions About Treatment Satisfaction in the DTSQ at the End of Study Stratified by the Number of Daily Doses of Medication for Treatment of Comorbidities (&lt;2 Times or ≥2 Times) at Baseline</title>
          <description>The DTSQ is a self-reported instrument consists of 6 questions about treatment satisfaction and 2 questions regarding blood sugar level. Each question answered on a 7-point Likert scale from 0 to 6, based on concern with the diabetes treatment and experiences in the past few weeks. Higher total score for questions about treatment satisfaction indicate greater satisfaction with treatment and experiences.</description>
          <population>Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. This outcome measure was analyzed with FAS in participants who had any medication for concurrent condition at baseline.</population>
          <units>Units on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>&lt;2 times</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" spread="8.29"/>
                    <measurement group_id="O2" value="1.2" spread="4.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥2 times</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.8" spread="9.71"/>
                    <measurement group_id="O2" value="2.0" spread="4.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Total Score for All Question Items in the DTR-QOL Questionnaire at the End of Study Stratified by the Total Number of Daily Tablets of Medication for Treatment of Comorbidities (&lt;2 Tablets or ≥2 Tablets) at Baseline</title>
        <description>DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13 questions), Factor 2: Anxiety and dissatisfaction with treatment (8 questions), Factor 3: Hypoglycemia (4 questions) and Factor 4: Treatment satisfaction (4 questions). Each item is scored ranging from 1 to 7. Every score of the questions in Factor 1-3 and the score in Factor 4 converted into reverse (1-7 will be converted to 7-1) will be simply added up, and scores of each factor and the total figure will be subsequently converted from 0 to 100 (the best and worst scores will be equivalent to 100 and 0). Higher scores reflect better QOL and positive changes relative to baseline indicate improvement of QOL.</description>
        <time_frame>Baseline (Week 0), up to the end of study (Week 12)</time_frame>
        <population>Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. This outcome measure was analyzed with FAS in participants who had any medication for concurrent condition at baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>Trelagliptin</title>
            <description>Trelagliptin 100 mg, orally, once weekly for up to 12 weeks. Trelagliptin 50 mg, orally, once weekly for up to 12 weeks in patients with moderate renal impairment.</description>
          </group>
          <group group_id="O2">
            <title>Daily DPP-4 Inhibitors</title>
            <description>An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Total Score for All Question Items in the DTR-QOL Questionnaire at the End of Study Stratified by the Total Number of Daily Tablets of Medication for Treatment of Comorbidities (&lt;2 Tablets or ≥2 Tablets) at Baseline</title>
          <description>DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13 questions), Factor 2: Anxiety and dissatisfaction with treatment (8 questions), Factor 3: Hypoglycemia (4 questions) and Factor 4: Treatment satisfaction (4 questions). Each item is scored ranging from 1 to 7. Every score of the questions in Factor 1-3 and the score in Factor 4 converted into reverse (1-7 will be converted to 7-1) will be simply added up, and scores of each factor and the total figure will be subsequently converted from 0 to 100 (the best and worst scores will be equivalent to 100 and 0). Higher scores reflect better QOL and positive changes relative to baseline indicate improvement of QOL.</description>
          <population>Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. This outcome measure was analyzed with FAS in participants who had any medication for concurrent condition at baseline.</population>
          <units>Units on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>&lt;2 tablets</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="44"/>
                    <count group_id="O2" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.72" spread="16.048"/>
                    <measurement group_id="O2" value="6.00" spread="11.346"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥2 tablets</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.88" spread="13.008"/>
                    <measurement group_id="O2" value="3.26" spread="13.809"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Total Score for Questions About Treatment Satisfaction in the DTSQ at the End of Study Stratified by the Total Number of Daily Tablets of Medication for Treatment of Comorbidities (&lt;2 Tablets or ≥2 Tablets) at Baseline</title>
        <description>The DTSQ is a self-reported instrument consists of 6 questions about treatment satisfaction and 2 questions regarding blood sugar level. Each question answered on a 7-point Likert scale from 0 to 6, based on concern with the diabetes treatment and experiences in the past few weeks. Higher total score for questions about treatment satisfaction indicate greater satisfaction with treatment and experiences.</description>
        <time_frame>Baseline (Week 0), up to the end of study (Week 12)</time_frame>
        <population>Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. This outcome measure was analyzed with FAS in participants who had any medication for concurrent condition at baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>Trelagliptin</title>
            <description>Trelagliptin 100 mg, orally, once weekly for up to 12 weeks. Trelagliptin 50 mg, orally, once weekly for up to 12 weeks in patients with moderate renal impairment.</description>
          </group>
          <group group_id="O2">
            <title>Daily DPP-4 Inhibitors</title>
            <description>An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Total Score for Questions About Treatment Satisfaction in the DTSQ at the End of Study Stratified by the Total Number of Daily Tablets of Medication for Treatment of Comorbidities (&lt;2 Tablets or ≥2 Tablets) at Baseline</title>
          <description>The DTSQ is a self-reported instrument consists of 6 questions about treatment satisfaction and 2 questions regarding blood sugar level. Each question answered on a 7-point Likert scale from 0 to 6, based on concern with the diabetes treatment and experiences in the past few weeks. Higher total score for questions about treatment satisfaction indicate greater satisfaction with treatment and experiences.</description>
          <population>Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. This outcome measure was analyzed with FAS in participants who had any medication for concurrent condition at baseline.</population>
          <units>Units on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>&lt;2 tablets</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="44"/>
                    <count group_id="O2" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" spread="8.42"/>
                    <measurement group_id="O2" value="1.2" spread="4.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥2 tablets</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.3" spread="7.71"/>
                    <measurement group_id="O2" value="1.7" spread="3.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Total Score for All Question Items in the DTR-QOL Questionnaire at the End of Study Stratified by the Number of Doses of the Study Drug or Comparative Drug (Once Weekly, Once Daily or Twice Daily) at Baseline</title>
        <description>DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13 questions), Factor 2: Anxiety and dissatisfaction with treatment (8 questions), Factor 3: Hypoglycemia (4 questions) and Factor 4: Treatment satisfaction (4 questions). Each item is scored ranging from 1 to 7. Every score of the questions in Factor 1-3 and the score in Factor 4 converted into reverse (1-7 will be converted to 7-1) will be simply added up, and scores of each factor and the total figure will be subsequently converted from 0 to 100 (the best and worst scores will be equivalent to 100 and 0). Higher scores reflect better QOL and positive changes relative to baseline indicate improvement of QOL.</description>
        <time_frame>Baseline (Week 0), up to the end of study (Week 12)</time_frame>
        <population>Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given population.</population>
        <group_list>
          <group group_id="O1">
            <title>Trelagliptin</title>
            <description>Trelagliptin 100 mg, orally, once weekly for up to 12 weeks. Trelagliptin 50 mg, orally, once weekly for up to 12 weeks in patients with moderate renal impairment.</description>
          </group>
          <group group_id="O2">
            <title>Daily DPP-4 Inhibitors</title>
            <description>An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Total Score for All Question Items in the DTR-QOL Questionnaire at the End of Study Stratified by the Number of Doses of the Study Drug or Comparative Drug (Once Weekly, Once Daily or Twice Daily) at Baseline</title>
          <description>DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13 questions), Factor 2: Anxiety and dissatisfaction with treatment (8 questions), Factor 3: Hypoglycemia (4 questions) and Factor 4: Treatment satisfaction (4 questions). Each item is scored ranging from 1 to 7. Every score of the questions in Factor 1-3 and the score in Factor 4 converted into reverse (1-7 will be converted to 7-1) will be simply added up, and scores of each factor and the total figure will be subsequently converted from 0 to 100 (the best and worst scores will be equivalent to 100 and 0). Higher scores reflect better QOL and positive changes relative to baseline indicate improvement of QOL.</description>
          <population>Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given population.</population>
          <units>Units on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="110"/>
                <count group_id="O2" value="108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Once Weekly</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="110"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.72" spread="16.162"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Once Daily</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="6.90" spread="14.204"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Twice Daily</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.50" spread="11.176"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Total Score for Questions About Treatment Satisfaction in the DTSQ at the End of Study Stratified by the Number of Doses of the Study Drug or Comparative Drug (Once Weekly, Once Daily or Twice Daily) at Baseline</title>
        <description>The DTSQ is a self-reported instrument consists of 6 questions about treatment satisfaction and 2 questions regarding blood sugar level. Each question answered on a 7-point Likert scale from 0 to 6, based on concern with the diabetes treatment and experiences in the past few weeks. Higher total score for questions about treatment satisfaction indicate greater satisfaction with treatment and experiences.</description>
        <time_frame>Baseline (Week 0), up to the end of study (Week 12)</time_frame>
        <population>Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given population.</population>
        <group_list>
          <group group_id="O1">
            <title>Trelagliptin</title>
            <description>Trelagliptin 100 mg, orally, once weekly for up to 12 weeks. Trelagliptin 50 mg, orally, once weekly for up to 12 weeks in patients with moderate renal impairment.</description>
          </group>
          <group group_id="O2">
            <title>Daily DPP-4 Inhibitors</title>
            <description>An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Total Score for Questions About Treatment Satisfaction in the DTSQ at the End of Study Stratified by the Number of Doses of the Study Drug or Comparative Drug (Once Weekly, Once Daily or Twice Daily) at Baseline</title>
          <description>The DTSQ is a self-reported instrument consists of 6 questions about treatment satisfaction and 2 questions regarding blood sugar level. Each question answered on a 7-point Likert scale from 0 to 6, based on concern with the diabetes treatment and experiences in the past few weeks. Higher total score for questions about treatment satisfaction indicate greater satisfaction with treatment and experiences.</description>
          <population>Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given population.</population>
          <units>Units on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="108"/>
                <count group_id="O2" value="108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Once Weekly</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="108"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" spread="7.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Once Daily</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="2.8" spread="6.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Twice Daily</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.5" spread="11.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study</title>
        <description>DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13 questions), Factor 2: Anxiety and dissatisfaction with treatment (8 questions), Factor 3: Hypoglycemia (4 questions) and Factor 4: Treatment satisfaction (4 questions). Each item is scored ranging from 1 to 7. Every score of the questions in Factor 1-3 and the score in Factor 4 converted into reverse (1-7 will be converted to 7-1) will be simply added up, and scores of each factor and the total figure will be subsequently converted from 0 to 100 (the best and worst scores will be equivalent to 100 and 0). Higher scores reflect better QOL and positive changes relative to baseline indicate improvement of QOL.</description>
        <time_frame>Baseline (Week 0), up to end of study (Week 12)</time_frame>
        <population>Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Trelagliptin</title>
            <description>Trelagliptin 100 mg, orally, once weekly for up to 12 weeks. Trelagliptin 50 mg, orally, once weekly for up to 12 weeks in patients with moderate renal impairment.</description>
          </group>
          <group group_id="O2">
            <title>Daily DPP-4 Inhibitors</title>
            <description>An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study</title>
          <description>DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13 questions), Factor 2: Anxiety and dissatisfaction with treatment (8 questions), Factor 3: Hypoglycemia (4 questions) and Factor 4: Treatment satisfaction (4 questions). Each item is scored ranging from 1 to 7. Every score of the questions in Factor 1-3 and the score in Factor 4 converted into reverse (1-7 will be converted to 7-1) will be simply added up, and scores of each factor and the total figure will be subsequently converted from 0 to 100 (the best and worst scores will be equivalent to 100 and 0). Higher scores reflect better QOL and positive changes relative to baseline indicate improvement of QOL.</description>
          <population>Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.</population>
          <units>Units on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="110"/>
                <count group_id="O2" value="108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Question Number 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="2.39"/>
                    <measurement group_id="O2" value="0.5" spread="1.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question Number 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" spread="2.25"/>
                    <measurement group_id="O2" value="0.7" spread="1.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question Number 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" spread="1.89"/>
                    <measurement group_id="O2" value="0.2" spread="1.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question Number 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="2.27"/>
                    <measurement group_id="O2" value="0.5" spread="1.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question Number 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="1.73"/>
                    <measurement group_id="O2" value="0.4" spread="1.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question Number 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" spread="1.90"/>
                    <measurement group_id="O2" value="0.5" spread="1.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question Number 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="1.83"/>
                    <measurement group_id="O2" value="0.7" spread="1.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question Number 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="1.80"/>
                    <measurement group_id="O2" value="1.0" spread="1.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question Number 9</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="1.85"/>
                    <measurement group_id="O2" value="0.5" spread="1.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question Number 10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="1.64"/>
                    <measurement group_id="O2" value="0.5" spread="1.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question Number 11</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="1.71"/>
                    <measurement group_id="O2" value="0.3" spread="1.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question Number 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" spread="1.54"/>
                    <measurement group_id="O2" value="0.5" spread="1.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question Number 13</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" spread="1.59"/>
                    <measurement group_id="O2" value="0.6" spread="1.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question Number 14</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" spread="1.62"/>
                    <measurement group_id="O2" value="0.4" spread="1.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question Number 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="1.75"/>
                    <measurement group_id="O2" value="0.3" spread="1.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question Number 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="1.54"/>
                    <measurement group_id="O2" value="0.5" spread="1.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question Number 17</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="1.44"/>
                    <measurement group_id="O2" value="0.4" spread="1.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question Number 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" spread="1.65"/>
                    <measurement group_id="O2" value="0.4" spread="1.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question Number 19</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="1.72"/>
                    <measurement group_id="O2" value="0.2" spread="1.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question Number 20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" spread="1.95"/>
                    <measurement group_id="O2" value="0.1" spread="1.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question Number 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="1.72"/>
                    <measurement group_id="O2" value="0.0" spread="1.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question Number 22</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" spread="1.71"/>
                    <measurement group_id="O2" value="0.1" spread="1.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question Number 23</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="1.81"/>
                    <measurement group_id="O2" value="0.1" spread="1.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question Number 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="1.91"/>
                    <measurement group_id="O2" value="0.1" spread="1.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question Number 25</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="1.68"/>
                    <measurement group_id="O2" value="0.0" spread="1.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question Number 26</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="1.89"/>
                    <measurement group_id="O2" value="0.4" spread="1.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question Number 27</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="1.77"/>
                    <measurement group_id="O2" value="0.3" spread="1.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question Number 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="1.69"/>
                    <measurement group_id="O2" value="0.3" spread="1.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question Number 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="1.59"/>
                    <measurement group_id="O2" value="0.4" spread="1.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Score Per Question in the the DTSQ at the End of Study</title>
        <description>The DTSQ is a self-reported instrument consists of 6 questions about treatment satisfaction and 2 questions regarding blood sugar level. Each question answered on a 7-point Likert scale from 0 to 6, based on concern with the diabetes treatment and experiences in the past few weeks. Higher total score for questions about treatment satisfaction indicate greater satisfaction with treatment and experiences.</description>
        <time_frame>Baseline (Week 0), up to end of study (Week 12)</time_frame>
        <population>Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Trelagliptin</title>
            <description>Trelagliptin 100 mg, orally, once weekly for up to 12 weeks. Trelagliptin 50 mg, orally, once weekly for up to 12 weeks in patients with moderate renal impairment.</description>
          </group>
          <group group_id="O2">
            <title>Daily DPP-4 Inhibitors</title>
            <description>An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Score Per Question in the the DTSQ at the End of Study</title>
          <description>The DTSQ is a self-reported instrument consists of 6 questions about treatment satisfaction and 2 questions regarding blood sugar level. Each question answered on a 7-point Likert scale from 0 to 6, based on concern with the diabetes treatment and experiences in the past few weeks. Higher total score for questions about treatment satisfaction indicate greater satisfaction with treatment and experiences.</description>
          <population>Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis.</population>
          <units>Units on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="108"/>
                <count group_id="O2" value="108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Question Number 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="1.50"/>
                    <measurement group_id="O2" value="0.6" spread="1.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question Number 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4" spread="1.77"/>
                    <measurement group_id="O2" value="-0.5" spread="2.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question Number 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="1.54"/>
                    <measurement group_id="O2" value="-0.2" spread="1.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question Number 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="1.57"/>
                    <measurement group_id="O2" value="0.5" spread="1.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question Number 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" spread="1.61"/>
                    <measurement group_id="O2" value="0.5" spread="1.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question Number 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="1.47"/>
                    <measurement group_id="O2" value="0.2" spread="1.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question Number 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" spread="1.51"/>
                    <measurement group_id="O2" value="0.3" spread="1.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question Number 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" spread="1.44"/>
                    <measurement group_id="O2" value="0.4" spread="1.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Reporting One or More Treatment-emergent Adverse Events</title>
        <description>An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.</description>
        <time_frame>Up to 12 weeks</time_frame>
        <population>Safety Analysis Set: All participants who received at least 1 dose of the study drug for the treatment period.</population>
        <group_list>
          <group group_id="O1">
            <title>Trelagliptin</title>
            <description>Trelagliptin 100 mg, orally, once weekly for up to 12 weeks. Trelagliptin 50 mg, orally, once weekly for up to 12 weeks in patients with moderate renal impairment.</description>
          </group>
          <group group_id="O2">
            <title>Daily DPP-4 Inhibitors</title>
            <description>An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting One or More Treatment-emergent Adverse Events</title>
          <description>An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.</description>
          <population>Safety Analysis Set: All participants who received at least 1 dose of the study drug for the treatment period.</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="110"/>
                <count group_id="O2" value="108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Reporting One or More Hypoglycemia</title>
        <time_frame>Up to 12 weeks</time_frame>
        <population>Safety Analysis Set: All participants who received at least 1 dose of the study drug for the treatment period.</population>
        <group_list>
          <group group_id="O1">
            <title>Trelagliptin</title>
            <description>Trelagliptin 100 mg, orally, once weekly for up to 12 weeks. Trelagliptin 50 mg, orally, once weekly for up to 12 weeks in patients with moderate renal impairment.</description>
          </group>
          <group group_id="O2">
            <title>Daily DPP-4 Inhibitors</title>
            <description>An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting One or More Hypoglycemia</title>
          <population>Safety Analysis Set: All participants who received at least 1 dose of the study drug for the treatment period.</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="110"/>
                <count group_id="O2" value="108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Hospitalization for Type 2 Diabetes (Excluding Educational Hospitalization Without Worsening of Diabetes)</title>
        <description>The investigators checked any hospitalization of study participants for type 2 diabetes after the first administration of the study drug or comparative drug (excluding educational hospitalization without worsening of diabetes).</description>
        <time_frame>Up to 12 weeks</time_frame>
        <population>There were no participants with hospitalization related to type 2 diabetes mellitus during this study.</population>
        <group_list>
          <group group_id="O1">
            <title>Trelagliptin</title>
            <description>Trelagliptin 100 mg, orally, once weekly for up to 12 weeks. Trelagliptin 50 mg, orally, once weekly for up to 12 weeks in patients with moderate renal impairment.</description>
          </group>
          <group group_id="O2">
            <title>Daily DPP-4 Inhibitors</title>
            <description>An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Hospitalization for Type 2 Diabetes (Excluding Educational Hospitalization Without Worsening of Diabetes)</title>
          <description>The investigators checked any hospitalization of study participants for type 2 diabetes after the first administration of the study drug or comparative drug (excluding educational hospitalization without worsening of diabetes).</description>
          <population>There were no participants with hospitalization related to type 2 diabetes mellitus during this study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Hospitalization for Type 2 Diabetes (Excluding Educational Hospitalization Without Worsening of Diabetes)</title>
        <time_frame>Up to 12 weeks</time_frame>
        <population>Safety Analysis Set: All participants who received at least 1 dose of the study drug for the treatment period.</population>
        <group_list>
          <group group_id="O1">
            <title>Trelagliptin</title>
            <description>Trelagliptin 100 mg, orally, once weekly for up to 12 weeks. Trelagliptin 50 mg, orally, once weekly for up to 12 weeks in patients with moderate renal impairment.</description>
          </group>
          <group group_id="O2">
            <title>Daily DPP-4 Inhibitors</title>
            <description>An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Hospitalization for Type 2 Diabetes (Excluding Educational Hospitalization Without Worsening of Diabetes)</title>
          <population>Safety Analysis Set: All participants who received at least 1 dose of the study drug for the treatment period.</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="110"/>
                <count group_id="O2" value="108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to Week 12</time_frame>
      <desc>At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.</desc>
      <group_list>
        <group group_id="E1">
          <title>Trelagliptin</title>
          <description>Trelagliptin 100 mg, orally, once weekly for up to 12 weeks. Trelagliptin 50 mg, orally, once weekly for up to 12 weeks in patients with moderate renal impairment.</description>
        </group>
        <group group_id="E2">
          <title>Daily DPP-4 Inhibitors</title>
          <description>An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>20.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="108"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_vocab>20.0</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="4" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="108"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="108"/>
              </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/NCT03014479
org study id: Trelagliptin-4002
secondary id: JapicCTI-173482
secondary id: U1111-1189-9256
nct id: NCT03014479
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to assess the reduction in treatment burden during 12 weeks of
      trelagliptin administration in patients with type 2 diabetes on diet and exercise therapy
      only.
The purpose of this study is to assess the reduction in treatment burden during 12 weeks of
      trelagliptin administration in patients with type 2 diabetes on diet and exercise therapy
      only. Eligible participants will be randomized to either the study drug (trelagliptin) group
      or the comparative drug (daily DPP-4 inhibitor) group. Treatment burden will be assessed
      using Diabetes Therapy Related -QOL (DTR-QOL) questionnaire and Diabetes Treatment
      Satisfaction Questionnaire (DTSQ).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change From Baseline in Total Score for All Question Items in the Diabetes Therapy Related -QOL (DTR-QOL) Questionnaire at the End of Study
time frame: Baseline (Week 0), up to the end of study (Week 12)
description: DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13 questions), Factor 2: Anxiety and dissatisfaction with treatment (8 questions), Factor 3: Hypoglycemia (4 questions) and Factor 4: Treatment satisfaction (4 questions). Each item is scored ranging from 1 to 7. Every score of the questions in Factor 1-3 and the score in Factor 4 converted into reverse (1-7 will be converted to 7-1) will be simply added up, and scores of each factor and the total figure will be subsequently converted from 0 to 100 (the best and worst scores will be equivalent to 100 and 0). Higher scores reflect better QOL and positive changes relative to baseline indicate improvement of QOL.
measure: Change From Baseline in Total Score for Each Factor Provided Through the DTR-QOL Questionnaire [Factor 1: Burden on Social Activities and Daily Activities] at Each Assessment Time Point
time frame: Baseline (Week 0), up to Week 4, 12, and the end of study (Week 12)
description: DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13 questions), Factor 2: Anxiety and dissatisfaction with treatment (8 questions), Factor 3: Hypoglycemia (4 questions) and Factor 4: Treatment satisfaction (4 questions). Each item is scored ranging from 1 to 7. Every score of the questions in Factor 1-3 and the score in Factor 4 converted into reverse (1-7 will be converted to 7-1) will be simply added up, and scores of each factor and the total figure will be subsequently converted from 0 to 100 (the best and worst scores will be equivalent to 100 and 0). Higher scores reflect better QOL and positive changes relative to baseline indicate improvement of QOL.
measure: Change From Baseline in Total Score for Each Factor Provided Through the DTR-QOL Questionnaire [Factor 2: Anxiety and Dissatisfaction With Treatments] at Each Assessment Time Point
time frame: Baseline (Week 0), up to Week 4, 12, and the end of study (Week 12)
description: DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13 questions), Factor 2: Anxiety and dissatisfaction with treatment (8 questions), Factor 3: Hypoglycemia (4 questions) and Factor 4: Treatment satisfaction (4 questions). Each item is scored ranging from 1 to 7. Every score of the questions in Factor 1-3 and the score in Factor 4 converted into reverse (1-7 will be converted to 7-1) will be simply added up, and scores of each factor and the total figure will be subsequently converted from 0 to 100 (the best and worst scores will be equivalent to 100 and 0). Higher scores reflect better QOL and positive changes relative to baseline indicate improvement of QOL.
measure: Change From Baseline in Total Score for Each Factor Provided Through the DTR-QOL Questionnaire [Factor 3: Hypoglycemia] at Each Assessment Time Point
time frame: Baseline (Week 0), up to Week 4, 12, and the end of study (Week 12)
description: DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13 questions), Factor 2: Anxiety and dissatisfaction with treatment (8 questions), Factor 3: Hypoglycemia (4 questions) and Factor 4: Treatment satisfaction (4 questions). Each item is scored ranging from 1 to 7. Every score of the questions in Factor 1-3 and the score in Factor 4 converted into reverse (1-7 will be converted to 7-1) will be simply added up, and scores of each factor and the total figure will be subsequently converted from 0 to 100 (the best and worst scores will be equivalent to 100 and 0). Higher scores reflect better QOL and positive changes relative to baseline indicate improvement of QOL.
measure: Change From Baseline in Total Score for Each Factor Provided Through the DTR-QOL Questionnaire [Factor 4: Satisfaction With Treatment] at Each Assessment Time Point
time frame: Baseline (Week 0), up to Week 4, 12, and the end of study (Week 12)
description: DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13 questions), Factor 2: Anxiety and dissatisfaction with treatment (8 questions), Factor 3: Hypoglycemia (4 questions) and Factor 4: Treatment satisfaction (4 questions). Each item is scored ranging from 1 to 7. Every score of the questions in Factor 1-3 and the score in Factor 4 converted into reverse (1-7 will be converted to 7-1) will be simply added up, and scores of each factor and the total figure will be subsequently converted from 0 to 100 (the best and worst scores will be equivalent to 100 and 0). Higher scores reflect better QOL and positive changes relative to baseline indicate improvement of QOL.
measure: Change From Baseline in Total Score for All Question Items in the DTR-QOL Questionnaire at Each Assessment Time Point
time frame: Baseline (Week 0), up to Week 4, 12
description: DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13 questions), Factor 2: Anxiety and dissatisfaction with treatment (8 questions), Factor 3: Hypoglycemia (4 questions) and Factor 4: Treatment satisfaction (4 questions). Each item is scored ranging from 1 to 7. Every score of the questions in Factor 1-3 and the score in Factor 4 converted into reverse (1-7 will be converted to 7-1) will be simply added up, and scores of each factor and the total figure will be subsequently converted from 0 to 100 (the best and worst scores will be equivalent to 100 and 0). Higher scores reflect better QOL and positive changes relative to baseline indicate improvement of QOL.
measure: Change From Baseline in Total Score for Questions About Treatment Satisfaction in the Diabetes Treatment Satisfaction Questionnaire (DTSQ) at Each Assessment Time Point
time frame: Baseline (Week 0), up to Week 4, 12 and the end of study (Week 12)
description: The DTSQ is a self-reported instrument consists of 6 questions about treatment satisfaction and 2 questions regarding blood sugar level. Each question answered on a 7-point Likert scale from 0 to 6, based on concern with the diabetes treatment and experiences in the past few weeks. Higher total score for questions about treatment satisfaction indicate greater satisfaction with treatment and experiences.
measure: Change From Baseline in Total Score for All Question Items in the DTR-QOL Questionnaire at the End of Study Stratified by the Use of Medication for Treatment of Comorbidities at Baseline
time frame: Baseline (Week 0), up to the end of study (Week 12)
description: DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13 questions), Factor 2: Anxiety and dissatisfaction with treatment (8 questions), Factor 3: Hypoglycemia (4 questions) and Factor 4: Treatment satisfaction (4 questions). Each item is scored ranging from 1 to 7. Every score of the questions in Factor 1-3 and the score in Factor 4 converted into reverse (1-7 will be converted to 7-1) will be simply added up, and scores of each factor and the total figure will be subsequently converted from 0 to 100 (the best and worst scores will be equivalent to 100 and 0). Higher scores reflect better QOL and positive changes relative to baseline indicate improvement of QOL. Reported data was the score stratified by the use of medication for treatment of comorbidities at baseline (Used/ Not used).
measure: Change From Baseline in Total Score for Questions About Treatment Satisfaction in the DTSQ at the End of Study Stratified by the Use of Medication for Treatment of Comorbidities at Baseline
time frame: Baseline (Week 0), up to the end of study (Week 12)
description: The DTSQ is a self-reported instrument consists of 6 questions about treatment satisfaction and 2 questions regarding blood sugar level. Each question answered on a 7-point Likert scale from 0 to 6, based on concern with the diabetes treatment and experiences in the past few weeks. Higher total score for questions about treatment satisfaction indicate greater satisfaction with treatment and experiences. Reported data was the score stratified by the use of medication for treatment of comorbidities at baseline (Used/ Not used).
measure: Change From Baseline in Total Score for All Question Items in the DTR-QOL Questionnaire at the End of Study Stratified by the Number of Daily Doses of Medication for Treatment of Comorbidities (<2 Times or ≥2 Times) at Baseline
time frame: Baseline (Week 0), up to the end of study (Week 12)
description: DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13 questions), Factor 2: Anxiety and dissatisfaction with treatment (8 questions), Factor 3: Hypoglycemia (4 questions) and Factor 4: Treatment satisfaction (4 questions). Each item is scored ranging from 1 to 7. Every score of the questions in Factor 1-3 and the score in Factor 4 converted into reverse (1-7 will be converted to 7-1) will be simply added up, and scores of each factor and the total figure will be subsequently converted from 0 to 100 (the best and worst scores will be equivalent to 100 and 0). Higher scores reflect better QOL and positive changes relative to baseline indicate improvement of QOL.
measure: Change From Baseline in Total Score for Questions About Treatment Satisfaction in the DTSQ at the End of Study Stratified by the Number of Daily Doses of Medication for Treatment of Comorbidities (<2 Times or ≥2 Times) at Baseline
time frame: Baseline (Week 0), up to the end of study (Week 12)
description: The DTSQ is a self-reported instrument consists of 6 questions about treatment satisfaction and 2 questions regarding blood sugar level. Each question answered on a 7-point Likert scale from 0 to 6, based on concern with the diabetes treatment and experiences in the past few weeks. Higher total score for questions about treatment satisfaction indicate greater satisfaction with treatment and experiences.
measure: Change From Baseline in Total Score for All Question Items in the DTR-QOL Questionnaire at the End of Study Stratified by the Total Number of Daily Tablets of Medication for Treatment of Comorbidities (<2 Tablets or ≥2 Tablets) at Baseline
time frame: Baseline (Week 0), up to the end of study (Week 12)
description: DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13 questions), Factor 2: Anxiety and dissatisfaction with treatment (8 questions), Factor 3: Hypoglycemia (4 questions) and Factor 4: Treatment satisfaction (4 questions). Each item is scored ranging from 1 to 7. Every score of the questions in Factor 1-3 and the score in Factor 4 converted into reverse (1-7 will be converted to 7-1) will be simply added up, and scores of each factor and the total figure will be subsequently converted from 0 to 100 (the best and worst scores will be equivalent to 100 and 0). Higher scores reflect better QOL and positive changes relative to baseline indicate improvement of QOL.
measure: Change From Baseline in Total Score for Questions About Treatment Satisfaction in the DTSQ at the End of Study Stratified by the Total Number of Daily Tablets of Medication for Treatment of Comorbidities (<2 Tablets or ≥2 Tablets) at Baseline
time frame: Baseline (Week 0), up to the end of study (Week 12)
description: The DTSQ is a self-reported instrument consists of 6 questions about treatment satisfaction and 2 questions regarding blood sugar level. Each question answered on a 7-point Likert scale from 0 to 6, based on concern with the diabetes treatment and experiences in the past few weeks. Higher total score for questions about treatment satisfaction indicate greater satisfaction with treatment and experiences.
measure: Change From Baseline in Total Score for All Question Items in the DTR-QOL Questionnaire at the End of Study Stratified by the Number of Doses of the Study Drug or Comparative Drug (Once Weekly, Once Daily or Twice Daily) at Baseline
time frame: Baseline (Week 0), up to the end of study (Week 12)
description: DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13 questions), Factor 2: Anxiety and dissatisfaction with treatment (8 questions), Factor 3: Hypoglycemia (4 questions) and Factor 4: Treatment satisfaction (4 questions). Each item is scored ranging from 1 to 7. Every score of the questions in Factor 1-3 and the score in Factor 4 converted into reverse (1-7 will be converted to 7-1) will be simply added up, and scores of each factor and the total figure will be subsequently converted from 0 to 100 (the best and worst scores will be equivalent to 100 and 0). Higher scores reflect better QOL and positive changes relative to baseline indicate improvement of QOL.
measure: Change From Baseline in Total Score for Questions About Treatment Satisfaction in the DTSQ at the End of Study Stratified by the Number of Doses of the Study Drug or Comparative Drug (Once Weekly, Once Daily or Twice Daily) at Baseline
time frame: Baseline (Week 0), up to the end of study (Week 12)
description: The DTSQ is a self-reported instrument consists of 6 questions about treatment satisfaction and 2 questions regarding blood sugar level. Each question answered on a 7-point Likert scale from 0 to 6, based on concern with the diabetes treatment and experiences in the past few weeks. Higher total score for questions about treatment satisfaction indicate greater satisfaction with treatment and experiences.
measure: Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study
time frame: Baseline (Week 0), up to end of study (Week 12)
description: DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13 questions), Factor 2: Anxiety and dissatisfaction with treatment (8 questions), Factor 3: Hypoglycemia (4 questions) and Factor 4: Treatment satisfaction (4 questions). Each item is scored ranging from 1 to 7. Every score of the questions in Factor 1-3 and the score in Factor 4 converted into reverse (1-7 will be converted to 7-1) will be simply added up, and scores of each factor and the total figure will be subsequently converted from 0 to 100 (the best and worst scores will be equivalent to 100 and 0). Higher scores reflect better QOL and positive changes relative to baseline indicate improvement of QOL.
measure: Change From Baseline in Score Per Question in the the DTSQ at the End of Study
time frame: Baseline (Week 0), up to end of study (Week 12)
description: The DTSQ is a self-reported instrument consists of 6 questions about treatment satisfaction and 2 questions regarding blood sugar level. Each question answered on a 7-point Likert scale from 0 to 6, based on concern with the diabetes treatment and experiences in the past few weeks. Higher total score for questions about treatment satisfaction indicate greater satisfaction with treatment and experiences.
measure: Number of Participants Reporting One or More Treatment-emergent Adverse Events
time frame: Up to 12 weeks
description: An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
measure: Number of Participants Reporting One or More Hypoglycemia
time frame: Up to 12 weeks
measure: Duration of Hospitalization for Type 2 Diabetes (Excluding Educational Hospitalization Without Worsening of Diabetes)
time frame: Up to 12 weeks
description: The investigators checked any hospitalization of study participants for type 2 diabetes after the first administration of the study drug or comparative drug (excluding educational hospitalization without worsening of diabetes).
measure: Number of Participants With Hospitalization for Type 2 Diabetes (Excluding Educational Hospitalization Without Worsening of Diabetes)
time frame: Up to 12 weeks
arm group label: Trelagliptin
arm group type: Experimental
description: Trelagliptin 100 mg, orally, once weekly for up to 12 weeks. Trelagliptin 50 mg, orally, once weekly for up to 12 weeks in patients with moderate renal impairment.
arm group label: Daily DPP-4 inhibitors
arm group type: Active Comparator
description: An inhibitor orally administered at the dosage and administration in the package inserts for each drug, for up to 12 weeks.
intervention type: Drug
intervention name: Trelagliptin
description: Trelagliptin 100 mg or 50 mg
arm group label: Trelagliptin
intervention type: Drug
intervention name: Daily DPP-4 inhibitor
description: Alogliptin, anagliptin, linagliptin, saxagliptin, sitagliptin, teneligliptin or vildagliptin
arm group label: Daily DPP-4 inhibitors
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Study Director
role: Study Director
affiliation: Takeda
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country: Japan
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Dipeptidyl-Peptidase IV Inhibitors
sharing ipd: Yes
ipd description: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
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