<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/NCT03785522</url>
  </required_header>
  <id_info>
    <org_study_id>NN1250-4440</org_study_id>
    <secondary_id>U1111-1208-5065</secondary_id>
    <nct_id>NCT03785522</nct_id>
  </id_info>
  <brief_title>A Research Study, Looking at How Tresiba® Works in People With Type 2 Diabetes in Local Clinical Practice in Saudi Arabia</brief_title>
  <acronym>UPDATES</acronym>
  <official_title>A Prospective Non-interventional Study Investigating the Treatment Effect of Tresiba® in Adult Patients With Type 2 Diabetes in Saudi Arabia</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 the study is to collect information on how Tresiba® works in real world&#xD;
      patients. Patients will get Tresiba® as prescribed to them by their study doctor. The study&#xD;
      will last for about 6 to 8 months. Patients will be asked questions about their health and&#xD;
      diabetes treatment as part of their normal study doctor's appointment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 23, 2018</start_date>
  <completion_date type="Actual">November 30, 2020</completion_date>
  <primary_completion_date type="Actual">November 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in glycated haemoglobin (HbA1c) (percentage)</measure>
    <time_frame>Week 0 (baseline), Week 26 (end of study)</time_frame>
    <description>Measured in percentage. Baseline is defined as a period of less than or equal to 12 weeks prior to treatment initiation (week 0). If multiple values are available, the most recent one will be used for the baseline. End of study is defined as the first visit within the window from week 26 to week 34. If multiple values are available for a specific endpoint, the most recent one, relative to the end of study visit will be used.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in HbA1c (mmol/mol)</measure>
    <time_frame>Week 0 (baseline), Week 26 (end of study)</time_frame>
    <description>Measured in mmol/mol. Baseline is defined as a period of less than or equal to 12 weeks prior to treatment initiation (week 0). If multiple values are available, the most recent one will be used for the baseline. End of study is defined as the first visit within the window from week 26 to week 34. If multiple values are available for a specific endpoint, the most recent one, relative to the end of study visit will be used.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in fasting plasma glucose (FPG) (mg/dL)</measure>
    <time_frame>Week 0 (baseline), Week 26 (end of study)</time_frame>
    <description>Measured in mg/dL. Baseline is defined as a period of less than or equal to 12 weeks prior to treatment initiation (week 0). If multiple values are available, the most recent one will be used for the baseline. End of study is defined as the first visit within the window from week 26 to week 34. If multiple values are available for a specific endpoint, the most recent one, relative to the end of study visit will be used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in FPG (mmol/L)</measure>
    <time_frame>Week 0 (baseline), Week 26 (end of study)</time_frame>
    <description>Measured in mmol/L. Baseline is defined as a period of less than or equal to 12 weeks prior to treatment initiation (week 0). If multiple values are available, the most recent one will be used for the baseline. End of study is defined as the first visit within the window from week 26 to week 34. If multiple values are available for a specific endpoint, the most recent one, relative to the end of study visit will be used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in daily insulin doses: Basal insulin</measure>
    <time_frame>Week 0 (baseline), Week 26 (end of study)</time_frame>
    <description>Measured in units/day. Baseline dose is defined as the most recent dose prior to treatment initiation (week 0). End of study is defined as the first visit within the window from week 26 to week 34. If multiple values are available for a specific endpoint, the most recent one, relative to the end of study visit will be used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in daily insulin doses: Prandial insulin</measure>
    <time_frame>Week 0 (baseline), Week 26 (end of study)</time_frame>
    <description>Measured in units/day. Baseline dose is defined as the most recent dose prior to treatment initiation (week 0). End of study is defined as the first visit within the window from week 26 to week 34. If multiple values are available for a specific endpoint, the most recent one, relative to the end of study visit will be used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in daily insulin doses: Total insulin</measure>
    <time_frame>Week 0 (baseline), Week 26 (end of study)</time_frame>
    <description>Measured in units/day. Baseline dose is defined as the most recent dose prior to treatment initiation (week 0). End of study is defined as the first visit within the window from week 26 to week 34. If multiple values are available for a specific endpoint, the most recent one, relative to the end of study visit will be used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in number of patient reported overall non-severe hypoglycaemic episodes</measure>
    <time_frame>Week -4 to 0, week 22 to 26</time_frame>
    <description>Number of episodes occurring within 4 weeks prior to initiation of treatment with Tresiba® and within 4 weeks prior to end of study. Non-severe hypoglycaemia is defined as an episode with symptoms and/or self-measured blood glucose (SMBG) value less than or equal to 3.9 mmol/L.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in number of patient reported nocturnal non-severe hypoglycaemic episodes</measure>
    <time_frame>Week -4 to 0, week 22 to 26</time_frame>
    <description>Number of episodes occurring within 4 weeks prior to initiation of treatment with Tresiba® and within 4 weeks prior to end of study. The definition of &quot;nocturnal&quot; will be based on the patient's perception of whether or not it was night, i.e. the answer to this question to the patient: &quot;How many of these occurred between midnight and early morning&quot;?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in number of patient reported severe hypoglycaemic episodes (overall)</measure>
    <time_frame>Week -26 to 0, week 0 to 26</time_frame>
    <description>Number of episodes occurring within 26 weeks prior to initiation of treatment with Tresiba® and within 26 weeks prior to end of study. Severe hypoglycaemia is defined as an episode of hypoglycaemia requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective action. The patient should be asked: &quot;Were you able to treat yourself?&quot;, if assistance from another person was required the episode can be defined as severe.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reason(s) for discontinuing treatment with Tresiba® during the treatment period, if applicable</measure>
    <time_frame>Week 26</time_frame>
    <description>Pre-specified response option(s) after initiation of treatment with Tresiba® until treatment discontinuation.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">597</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Tresiba®</arm_group_label>
    <description>Patients with type 2 diabetes in Saudi Arabia are to receive Tresiba® (Insulin degludec) for 26 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Insulin degludec</intervention_name>
    <description>Patients will be treated with commercially available Tresiba® in a pre-filled pen injector (FlexTouch®) according to routine clinical practice at the discretion of the study doctor and in accordance with the local label. The study doctor will determine the starting dose of Tresiba® as well as any dose adjustments thereafter.</description>
    <arm_group_label>Tresiba®</arm_group_label>
    <other_name>Tresiba®</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with type 2 diabetes in Saudi Arabia treated with any antihyperglycaemic&#xD;
        medication(s), except Tresiba®, are eligible for this study.&#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 Tresiba® has been made&#xD;
             by the patient/legally acceptable representative and the treating physician before and&#xD;
             independently from the decision to include the patient in this study&#xD;
&#xD;
          -  Male or female, age above or equal to 18 years at the time of signing informed consent&#xD;
&#xD;
          -  Diagnosed with type 2 diabetes and treated with any antihyperglycaemic medication(s),&#xD;
             except Tresiba®, for at least 26 weeks prior to Informed consent and Initiation Visit&#xD;
             (Visit 1)&#xD;
&#xD;
          -  Available and documented HbA1c value measured within the last 12 weeks prior to&#xD;
             initiation of Tresiba® treatment&#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;
          -  Hypersensitivity to the active substance or to any of the excipients as specified in&#xD;
             the Tresiba® local label&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>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>Al Jubayl</city>
        <zip>35718</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Al Khobar</city>
        <zip>34234</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Al Khobar</city>
        <zip>34425</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>AL Qateef</city>
        <zip>31911</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Dammam</city>
        <zip>32236</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Dammam</city>
        <zip>32253</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Dammam</city>
        <zip>32263</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Ihsa</city>
        <zip>36364</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Jeddah</city>
        <zip>22231</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Jeddah</city>
        <zip>22252</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Jeddah</city>
        <zip>22324,</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Jeddah</city>
        <zip>23216</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Jeddah</city>
        <zip>23521</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Jeddah</city>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Makkah</city>
        <zip>24243</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Riyadh</city>
        <zip>11525</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Riyadh</city>
        <zip>12311</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Riyadh</city>
        <zip>12381</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Riyadh</city>
        <zip>12625</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Riyadh</city>
        <zip>14212</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Riyadh</city>
        <zip>14611</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>June 3, 2021</last_update_submitted>
  <last_update_submitted_qc>June 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2021</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>Insulin</mesh_term>
  </intervention_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>https://www.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/NCT03785522
org study id: NN1250-4440
secondary id: U1111-1208-5065
nct id: NCT03785522
lead sponsor: 
has dmc: No
is fda regulated device: No
The purpose of the study is to collect information on how Tresiba® works in real world
      patients. Patients will get Tresiba® as prescribed to them by their study doctor. The study
      will last for about 6 to 8 months. Patients will be asked questions about their health and
      diabetes treatment as part of their normal study doctor's appointment.
observational model: Cohort
time perspective: Prospective
measure: Change in glycated haemoglobin (HbA1c) (percentage)
time frame: Week 0 (baseline), Week 26 (end of study)
description: Measured in percentage. Baseline is defined as a period of less than or equal to 12 weeks prior to treatment initiation (week 0). If multiple values are available, the most recent one will be used for the baseline. End of study is defined as the first visit within the window from week 26 to week 34. If multiple values are available for a specific endpoint, the most recent one, relative to the end of study visit will be used.
measure: Change in HbA1c (mmol/mol)
time frame: Week 0 (baseline), Week 26 (end of study)
description: Measured in mmol/mol. Baseline is defined as a period of less than or equal to 12 weeks prior to treatment initiation (week 0). If multiple values are available, the most recent one will be used for the baseline. End of study is defined as the first visit within the window from week 26 to week 34. If multiple values are available for a specific endpoint, the most recent one, relative to the end of study visit will be used.
measure: Change in fasting plasma glucose (FPG) (mg/dL)
time frame: Week 0 (baseline), Week 26 (end of study)
description: Measured in mg/dL. Baseline is defined as a period of less than or equal to 12 weeks prior to treatment initiation (week 0). If multiple values are available, the most recent one will be used for the baseline. End of study is defined as the first visit within the window from week 26 to week 34. If multiple values are available for a specific endpoint, the most recent one, relative to the end of study visit will be used.
measure: Change in FPG (mmol/L)
time frame: Week 0 (baseline), Week 26 (end of study)
description: Measured in mmol/L. Baseline is defined as a period of less than or equal to 12 weeks prior to treatment initiation (week 0). If multiple values are available, the most recent one will be used for the baseline. End of study is defined as the first visit within the window from week 26 to week 34. If multiple values are available for a specific endpoint, the most recent one, relative to the end of study visit will be used.
measure: Change in daily insulin doses: Basal insulin
time frame: Week 0 (baseline), Week 26 (end of study)
description: Measured in units/day. Baseline dose is defined as the most recent dose prior to treatment initiation (week 0). End of study is defined as the first visit within the window from week 26 to week 34. If multiple values are available for a specific endpoint, the most recent one, relative to the end of study visit will be used.
measure: Change in daily insulin doses: Prandial insulin
time frame: Week 0 (baseline), Week 26 (end of study)
description: Measured in units/day. Baseline dose is defined as the most recent dose prior to treatment initiation (week 0). End of study is defined as the first visit within the window from week 26 to week 34. If multiple values are available for a specific endpoint, the most recent one, relative to the end of study visit will be used.
measure: Change in daily insulin doses: Total insulin
time frame: Week 0 (baseline), Week 26 (end of study)
description: Measured in units/day. Baseline dose is defined as the most recent dose prior to treatment initiation (week 0). End of study is defined as the first visit within the window from week 26 to week 34. If multiple values are available for a specific endpoint, the most recent one, relative to the end of study visit will be used.
measure: Change in number of patient reported overall non-severe hypoglycaemic episodes
time frame: Week -4 to 0, week 22 to 26
description: Number of episodes occurring within 4 weeks prior to initiation of treatment with Tresiba® and within 4 weeks prior to end of study. Non-severe hypoglycaemia is defined as an episode with symptoms and/or self-measured blood glucose (SMBG) value less than or equal to 3.9 mmol/L.
measure: Change in number of patient reported nocturnal non-severe hypoglycaemic episodes
time frame: Week -4 to 0, week 22 to 26
description: Number of episodes occurring within 4 weeks prior to initiation of treatment with Tresiba® and within 4 weeks prior to end of study. The definition of "nocturnal" will be based on the patient's perception of whether or not it was night, i.e. the answer to this question to the patient: "How many of these occurred between midnight and early morning"?
measure: Change in number of patient reported severe hypoglycaemic episodes (overall)
time frame: Week -26 to 0, week 0 to 26
description: Number of episodes occurring within 26 weeks prior to initiation of treatment with Tresiba® and within 26 weeks prior to end of study. Severe hypoglycaemia is defined as an episode of hypoglycaemia requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective action. The patient should be asked: "Were you able to treat yourself?", if assistance from another person was required the episode can be defined as severe.
measure: Reason(s) for discontinuing treatment with Tresiba® during the treatment period, if applicable
time frame: Week 26
description: Pre-specified response option(s) after initiation of treatment with Tresiba® until treatment discontinuation.
arm group label: Tresiba®
description: Patients with type 2 diabetes in Saudi Arabia are to receive Tresiba® (Insulin degludec) for 26 weeks.
intervention type: Drug
intervention name: Insulin degludec
description: Patients will be treated with commercially available Tresiba® in a pre-filled pen injector (FlexTouch®) according to routine clinical practice at the discretion of the study doctor and in accordance with the local label. The study doctor will determine the starting dose of Tresiba® as well as any dose adjustments thereafter.
arm group label: Tresiba®
other name: Tresiba®
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Reporting Anchor and Disclosure (1452)
role: Study Director
affiliation: Novo Nordisk A/S
facility: 
facility: 
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country: Saudi Arabia
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Insulin
sharing ipd: Yes
ipd description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
ipd url: https://www.novonordisk-trials.com