<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/NCT04469855</url>
  </required_header>
  <id_info>
    <org_study_id>NN9535-4347</org_study_id>
    <secondary_id>U1111-1187-9072</secondary_id>
    <nct_id>NCT04469855</nct_id>
  </id_info>
  <brief_title>Post-Marketing Surveillance (Special Use-results Surveillance) on Long-term Use With Ozempic®</brief_title>
  <official_title>Post-Marketing Surveillance (Special Use-results Surveillance) on Long-term Use With Ozempic®. A Multi-centre, Open-label, Non-interventional Post-marketing Study to Investigate the Long-term Safety and Effectiveness of Ozempic® (Semaglutide) in Japanese Patients With Type 2 Diabetes Mellitus Under Normal Clinical Practice Condition</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novo Nordisk A/S</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novo Nordisk A/S</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the safety of long-term treatment with Ozempic® in&#xD;
      patients with type 2 diabetes mellitus. People will get Ozempic® as prescribed by their&#xD;
      doctor. People will be in this study about 3 years. People above the age of 18 will be asked&#xD;
      to fill in the quality of life (QOL) questionnaire (the QOL questionnaire is for the&#xD;
      assessment of the influence of diabetes treatment on people's life). There is a possibility&#xD;
      that people's blood sample would be provided to Novo Nordisk from their doctors in case of&#xD;
      severe allergic reaction that might be caused by Ozempic®.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">July 27, 2020</start_date>
  <completion_date type="Anticipated">July 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2025</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of adverse events (AEs)</measure>
    <time_frame>From baseline (day 0) to end of study (month 36)</time_frame>
    <description>Count</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of serious adverse reactions (SARs)</measure>
    <time_frame>From baseline (day 0) to end of study (month 36)</time_frame>
    <description>Count</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of adverse reactions (ARs)</measure>
    <time_frame>From baseline (day 0) to end of study (month 36)</time_frame>
    <description>Count</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of serious adverse events (SAEs)</measure>
    <time_frame>From baseline (day 0) to end of study (month 36)</time_frame>
    <description>Count</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in glycosylated haemoglobin A1c (HbA1c)</measure>
    <time_frame>From baseline (day 0) to end of study (month 36)</time_frame>
    <description>Percent</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fasting plasma glucose (FPG)</measure>
    <time_frame>From baseline (day 0) to end of study (month 36)</time_frame>
    <description>mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in body weight</measure>
    <time_frame>From baseline (day 0) to end of study (month 36)</time_frame>
    <description>kg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in patient-reported outcomes (PROs) using the Diabetes Therapy-Related QOL (DTR-QOL) questionnaire - total score</measure>
    <time_frame>From baseline (day 0) to visit 5 (month 12)</time_frame>
    <description>DTR-QOL assesses the influence of diabetes treatment on the individual health related quality of life on 4 domains: &quot;burden on social activities and daily activities&quot;, &quot;anxiety and dissatisfaction with treatment&quot;, &quot;hypoglycaemia&quot; and &quot;satisfaction with treatment&quot;. DTR-QOL contains 29 items. The response scale used is a 7-point Likert scale (1:&#xD;
Strongly agree - 7: Strongly disagree)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in patient-reported outcomes (PROs) using the Diabetes Therapy-Related QOL (DTR-QOL) questionnaire - burden of social activities and daily activities</measure>
    <time_frame>From baseline (day 0) to visit 5 (month 12)</time_frame>
    <description>DTR-QOL assesses the influence of diabetes treatment on the individual health related quality of life on 4 domains: &quot;burden on social activities and daily activities&quot;, &quot;anxiety and dissatisfaction with treatment&quot;, &quot;hypoglycaemia&quot; and &quot;satisfaction with treatment&quot;. DTR-QOL contains 29 items. The response scale used is a 7-point Likert scale (1:&#xD;
Strongly agree - 7: Strongly disagree)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in patient-reported outcomes (PROs) using the Diabetes Therapy-Related QOL (DTR-QOL) questionnaire - anxiety and dissatisfaction with treatment</measure>
    <time_frame>From baseline (day 0) to visit 5 (month 12)</time_frame>
    <description>DTR-QOL assesses the influence of diabetes treatment on the individual health related quality of life on 4 domains: &quot;burden on social activities and daily activities&quot;, &quot;anxiety and dissatisfaction with treatment&quot;, &quot;hypoglycaemia&quot; and &quot;satisfaction with treatment&quot;. DTR-QOL contains 29 items. The response scale used is a 7-point Likert scale (1:&#xD;
Strongly agree - 7: Strongly disagree)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in patient-reported outcomes (PROs) using the Diabetes Therapy-Related QOL (DTR-QOL) questionnaire - hypoglycaemia</measure>
    <time_frame>From baseline (day 0) to visit 5 (month 12)</time_frame>
    <description>DTR-QOL assesses the influence of diabetes treatment on the individual health related quality of life on 4 domains: &quot;burden on social activities and daily activities&quot;, &quot;anxiety and dissatisfaction with treatment&quot;, &quot;hypoglycaemia&quot; and &quot;satisfaction with treatment&quot;. DTR-QOL contains 29 items. The response scale used is a 7-point Likert scale (1:&#xD;
Strongly agree - 7: Strongly disagree)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in patient-reported outcomes (PROs) using the Diabetes Therapy-Related QOL (DTR-QOL) questionnaire - satisfaction with treatment</measure>
    <time_frame>From baseline (day 0) to visit 5 (month 12)</time_frame>
    <description>DTR-QOL assesses the influence of diabetes treatment on the individual health related quality of life on 4 domains: &quot;burden on social activities and daily activities&quot;, &quot;anxiety and dissatisfaction with treatment&quot;, &quot;hypoglycaemia&quot; and &quot;satisfaction with treatment&quot;. DTR-QOL contains 29 items. The response scale used is a 7-point Likert scale (1:&#xD;
Strongly agree - 7: Strongly disagree)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">3000</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Ozempic®</arm_group_label>
    <description>Japanese people with type 2 diabetes being treated in normal clinical practice conditions</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>semaglutide</intervention_name>
    <description>Patients will be treated with commercially available Ozempic® according to routine clinical practice at the discretion of the treating physician. The treating physician's decision to initiate treatment with Ozempic® is independent of the decision to include the patient in the study.</description>
    <arm_group_label>Ozempic®</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Japanese people with type 2 diabetes being treated in normal clinical practice conditions&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed consent obtained before any study-related activities (study-related activities&#xD;
             are any procedure related to recording of data according to the protocol).&#xD;
&#xD;
          -  The decision to initiate treatment with commercially available Ozempic® has been made&#xD;
             by the patient/Legally Acceptable Representative (LAR) and the treating physician&#xD;
             before and independently from the decision to include the patient in this study.&#xD;
&#xD;
          -  Patients with Diabetes Mellitus, Type 2 (T2DM) who the physician has decided to start&#xD;
             treatment with Ozempic®.&#xD;
&#xD;
          -  Male or female, no age limitation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous participation in this study. Participation is defined as having given&#xD;
             informed consent in this study.&#xD;
&#xD;
          -  Mental incapacity, unwillingness or language barriers precluding adequate&#xD;
             understanding or cooperation.&#xD;
&#xD;
          -  Patients who fall under contraindications to the label.&#xD;
&#xD;
          -  Patients who are or have previously been treated with Ozempic®.&#xD;
&#xD;
          -  Female who is pregnant, breast-feeding or intends to become pregnant.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Reporting Anchor and Disclosure (1452)</last_name>
    <role>Study Director</role>
    <affiliation>Novo Nordisk A/S</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Koriyama-shi</city>
        <state>Fukushima, Japan</state>
        <zip>963-8851</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kamakura-shi</city>
        <state>Kanagawa, Japan</state>
        <zip>247 0056</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kawasaki-shi</city>
        <state>Kanagawa, Japan</state>
        <zip>212 0024</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kumamoto-shi</city>
        <state>Kumamoto, Japan</state>
        <zip>862-0976</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Miyazaki-shi</city>
        <state>Miyazaki, Japan</state>
        <zip>880-0034</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Oita-shi</city>
        <state>Oita, Japan</state>
        <zip>870 0039</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Izumisano-shi</city>
        <state>Osaka, Japan</state>
        <zip>598 0048</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kawagoe-shi</city>
        <state>Saitama, Japan</state>
        <zip>350-0851</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Minato-ku</city>
        <state>Tokyo, Japan</state>
        <zip>108 0073</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Imizu-shi</city>
        <state>Toyama, Japan</state>
        <zip>939 0363</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Aichi</city>
        <zip>441-8087</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Aichi</city>
        <zip>443-0022</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Aichi</city>
        <zip>446-0044</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Aichi</city>
        <zip>448-0852</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Aichi</city>
        <zip>450-0002</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Aichi</city>
        <zip>451-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Aichi</city>
        <zip>455-0815</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Aichi</city>
        <zip>455-0857</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Aichi</city>
        <zip>458-0011</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Aichi</city>
        <zip>462-0037</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Aichi</city>
        <zip>462-0047</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Aichi</city>
        <zip>468-0009</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Aichi</city>
        <zip>470-0345</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Aichi</city>
        <zip>472-0014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Aichi</city>
        <zip>476-0011</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Aichi</city>
        <zip>484-0066</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Aichi</city>
        <zip>485-0044</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Aichi</city>
        <zip>489-8642</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Akita</city>
        <zip>016-0014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Akita</city>
        <zip>017-8550</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Akita</city>
        <zip>018-4301</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Aomori</city>
        <zip>030-0823</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Aomori</city>
        <zip>038-0011</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Arakawa-ku, Tokyo</city>
        <zip>116-0012</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Asahikawa-shi, Hokkaido</city>
        <zip>078-8211</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Chiba-shi, Chiba</city>
        <zip>260-0804</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Chiba</city>
        <zip>264-0017</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Chiba</city>
        <zip>271-0044</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Chiba</city>
        <zip>272-0033</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Chiba</city>
        <zip>274-0063</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Chiba</city>
        <zip>274-0805</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Chiba</city>
        <zip>277-0084</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Chiba</city>
        <zip>277-8567</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Chiba</city>
        <zip>279-0001</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Chiba</city>
        <zip>283-0811</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Chiba</city>
        <zip>286-0221</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Chiba</city>
        <zip>290-0512</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Chiba</city>
        <zip>292-0822</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Chiba</city>
        <zip>295-0021</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Chiba</city>
        <zip>299-1144</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Chichibu-city</city>
        <zip>368-0004</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Chitose, Hokkaido</city>
        <zip>066-0032</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Ehime</city>
        <zip>790-0026</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Ehime</city>
        <zip>790-0034</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
    <facility>
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  <location>
    <facility>
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  <location>
    <facility>
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  <location>
    <facility>
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    <facility>
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  <location>
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  <location>
    <facility>
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  <location>
    <facility>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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    <facility>
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    <facility>
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    <facility>
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    <facility>
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        <zip>523-0082</zip>
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      </address>
    </facility>
  </location>
  <location>
    <facility>
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      <address>
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        <zip>526-8580</zip>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Shimane</city>
        <zip>690-0883</zip>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Shimane</city>
        <zip>691-0044</zip>
        <country>Japan</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Shimane</city>
        <zip>698-0046</zip>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Shimotsuga-gun, Tochigi</city>
        <zip>321-0204</zip>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Shimotsuke-shi, Tochigi</city>
        <zip>329-0433</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Shinjuku-ku, Tokyo</city>
        <zip>162-8655</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Shinjyuku-ku Tokyo</city>
        <zip>160-0022</zip>
        <country>Japan</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Shizuoka-city, Shizuoka</city>
        <zip>420-8630</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Shizuoka</city>
        <zip>410-0041</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Shizuoka</city>
        <zip>410-0822</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Shizuoka</city>
        <zip>411-0801</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Shizuoka</city>
        <zip>411-0816</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Shizuoka</city>
        <zip>420-0853</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Shizuoka</city>
        <zip>430-0802</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Shizuoka</city>
        <zip>431-3113</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Shizuoka</city>
        <zip>432-8580</zip>
        <country>Japan</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Soka-shi, Saitama</city>
        <zip>340-0034</zip>
        <country>Japan</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Suzaka-shi ,Nagano</city>
        <zip>382-0091</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tamana-shi, Kumamoto</city>
        <zip>865 0016</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tochigi</city>
        <zip>321-1271</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tochigi</city>
        <zip>323-0022</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tochigi</city>
        <zip>326-0053</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokorozawa-shi,Saitama</city>
        <zip>359-1141</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokushima</city>
        <zip>770-0022</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokushima</city>
        <zip>774-0014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokushima</city>
        <zip>779-3125</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>101-8643</zip>
        <country>Japan</country>
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  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>102-0074</zip>
        <country>Japan</country>
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  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>103-0007</zip>
        <country>Japan</country>
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  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>1040061</zip>
        <country>Japan</country>
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  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>105-0012</zip>
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  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>105-8471</zip>
        <country>Japan</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>108-0071</zip>
        <country>Japan</country>
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  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>108-8642</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>110-0015</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>110-0016</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>111-0032</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>116-0014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>124-0025</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>125-8506</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>133-0051</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>135-0002</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>135-0042</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>135-8550</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>142-0042</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>143-0016</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>143-8541</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>144-0052</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>145-0072</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>150-0013</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>153-0051</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>154-0017</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>155-0031</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>160-8488</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>165-8906</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>166-0004</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>176-8530</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>178-0063</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>178-0064</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>186-0002</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>190-0023</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>192-0083</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>193-0998</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>194-0013</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>198-0042</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>203-0053</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>206-0033</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tomigusuku-shi, Okinawa</city>
        <zip>901-0244</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tottori</city>
        <zip>680-0935</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tottori</city>
        <zip>683-8504</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Toyama-shi, Toyama</city>
        <zip>930-0194</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Toyama</city>
        <zip>939-0243</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Toyonaka-shi, Osaka</city>
        <zip>560-0082</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Wakayama</city>
        <zip>640-8558</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Yamagata</city>
        <zip>990-8510</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Yamagata</city>
        <zip>996-0035</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Yamaguchi</city>
        <zip>740-0034</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Yamaguchi</city>
        <zip>742-1102</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Yamaguchi</city>
        <zip>756-0095</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Yamanashi</city>
        <zip>405-0072</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Yamato-shi, Kanagawa</city>
        <zip>242-0004</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Yanagawa-shi, Fukuoka</city>
        <zip>832-0059</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Yokohama, Kanagawa</city>
        <zip>222-0036</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>November 10, 2022</last_update_submitted>
  <last_update_submitted_qc>November 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 14, 2022</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>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>According to the Novo Nordisk disclosure commitment on novonordisk-trials.com</ipd_description>
    <ipd_url>http://novonordisk-trials.com</ipd_url>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04469855
org study id: NN9535-4347
secondary id: U1111-1187-9072
nct id: NCT04469855
lead sponsor: 
has dmc: No
is fda regulated device: No
The purpose of this study is to assess the safety of long-term treatment with Ozempic® in
      patients with type 2 diabetes mellitus. People will get Ozempic® as prescribed by their
      doctor. People will be in this study about 3 years. People above the age of 18 will be asked
      to fill in the quality of life (QOL) questionnaire (the QOL questionnaire is for the
      assessment of the influence of diabetes treatment on people's life). There is a possibility
      that people's blood sample would be provided to Novo Nordisk from their doctors in case of
      severe allergic reaction that might be caused by Ozempic®.
observational model: Cohort
time perspective: Prospective
measure: Number of adverse events (AEs)
time frame: From baseline (day 0) to end of study (month 36)
description: Count
measure: Number of serious adverse reactions (SARs)
time frame: From baseline (day 0) to end of study (month 36)
description: Count
measure: Number of adverse reactions (ARs)
time frame: From baseline (day 0) to end of study (month 36)
description: Count
measure: Number of serious adverse events (SAEs)
time frame: From baseline (day 0) to end of study (month 36)
description: Count
measure: Change in glycosylated haemoglobin A1c (HbA1c)
time frame: From baseline (day 0) to end of study (month 36)
description: Percent
measure: Change in fasting plasma glucose (FPG)
time frame: From baseline (day 0) to end of study (month 36)
description: mg/dL
measure: Change in body weight
time frame: From baseline (day 0) to end of study (month 36)
description: kg
measure: Change in patient-reported outcomes (PROs) using the Diabetes Therapy-Related QOL (DTR-QOL) questionnaire - total score
time frame: From baseline (day 0) to visit 5 (month 12)
description: DTR-QOL assesses the influence of diabetes treatment on the individual health related quality of life on 4 domains: "burden on social activities and daily activities", "anxiety and dissatisfaction with treatment", "hypoglycaemia" and "satisfaction with treatment". DTR-QOL contains 29 items. The response scale used is a 7-point Likert scale (1:
Strongly agree - 7: Strongly disagree)
measure: Change in patient-reported outcomes (PROs) using the Diabetes Therapy-Related QOL (DTR-QOL) questionnaire - burden of social activities and daily activities
time frame: From baseline (day 0) to visit 5 (month 12)
description: DTR-QOL assesses the influence of diabetes treatment on the individual health related quality of life on 4 domains: "burden on social activities and daily activities", "anxiety and dissatisfaction with treatment", "hypoglycaemia" and "satisfaction with treatment". DTR-QOL contains 29 items. The response scale used is a 7-point Likert scale (1:
Strongly agree - 7: Strongly disagree)
measure: Change in patient-reported outcomes (PROs) using the Diabetes Therapy-Related QOL (DTR-QOL) questionnaire - anxiety and dissatisfaction with treatment
time frame: From baseline (day 0) to visit 5 (month 12)
description: DTR-QOL assesses the influence of diabetes treatment on the individual health related quality of life on 4 domains: "burden on social activities and daily activities", "anxiety and dissatisfaction with treatment", "hypoglycaemia" and "satisfaction with treatment". DTR-QOL contains 29 items. The response scale used is a 7-point Likert scale (1:
Strongly agree - 7: Strongly disagree)
measure: Change in patient-reported outcomes (PROs) using the Diabetes Therapy-Related QOL (DTR-QOL) questionnaire - hypoglycaemia
time frame: From baseline (day 0) to visit 5 (month 12)
description: DTR-QOL assesses the influence of diabetes treatment on the individual health related quality of life on 4 domains: "burden on social activities and daily activities", "anxiety and dissatisfaction with treatment", "hypoglycaemia" and "satisfaction with treatment". DTR-QOL contains 29 items. The response scale used is a 7-point Likert scale (1:
Strongly agree - 7: Strongly disagree)
measure: Change in patient-reported outcomes (PROs) using the Diabetes Therapy-Related QOL (DTR-QOL) questionnaire - satisfaction with treatment
time frame: From baseline (day 0) to visit 5 (month 12)
description: DTR-QOL assesses the influence of diabetes treatment on the individual health related quality of life on 4 domains: "burden on social activities and daily activities", "anxiety and dissatisfaction with treatment", "hypoglycaemia" and "satisfaction with treatment". DTR-QOL contains 29 items. The response scale used is a 7-point Likert scale (1:
Strongly agree - 7: Strongly disagree)
arm group label: Ozempic®
description: Japanese people with type 2 diabetes being treated in normal clinical practice conditions
intervention type: Drug
intervention name: semaglutide
description: Patients will be treated with commercially available Ozempic® according to routine clinical practice at the discretion of the treating physician. The treating physician's decision to initiate treatment with Ozempic® is independent of the decision to include the patient in the study.
arm group label: Ozempic®
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Clinical Reporting Anchor and Disclosure (1452)
role: Study Director
affiliation: Novo Nordisk A/S
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country: Japan
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: Yes
ipd description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
ipd url: http://novonordisk-trials.com