<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/NCT03823339</url>
  </required_header>
  <id_info>
    <org_study_id>NN9068-4458</org_study_id>
    <secondary_id>U1111-1213-4338</secondary_id>
    <nct_id>NCT03823339</nct_id>
  </id_info>
  <brief_title>A Research Study, Looking at How Xultophy® Works in People With Type 2 Diabetes in Local Clinical Practice in United Arab Emirates</brief_title>
  <acronym>INTENSIFY</acronym>
  <official_title>A Multicenter Prospective Non-interventional Study Investigating the Treatment Effect of Xultophy® Intensification in a Real World Population With Type 2 Diabetes in United Arab Emirates</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 Xultophy® works in patients with&#xD;
      type 2 diabetes. The participants will get Xultophy® as prescribed to them by the study&#xD;
      doctor. The study will last for about 26-34 weeks. The participants will be asked questions&#xD;
      about their health and their diabetes treatment as part of their normal study doctor's&#xD;
      appointment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 29, 2019</start_date>
  <completion_date type="Actual">December 14, 2020</completion_date>
  <primary_completion_date type="Actual">December 14, 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 laboratory measured glycosylated haemoglobin A1c (HbA1c)</measure>
    <time_frame>From baseline [≤12 weeks prior to treatment initiation [week 0]) to end of study (26-34 weeks)</time_frame>
    <description>Measured in % point</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patients reached HbA1c less than 7% at end of study (Yes/No )</measure>
    <time_frame>At the end of study visit (26-34 weeks)</time_frame>
    <description>Number of patients who achieved/not achieved HbA1c at end of study: &lt;7.0%</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in laboratory measured fasting plasma glucose (FPG)</measure>
    <time_frame>From baseline [≤12 weeks prior to treatment initiation [week 0]) to end of study (26-34 weeks)</time_frame>
    <description>Measured in mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average dose step of Xultophy® at end of the study</measure>
    <time_frame>At the end of study (26-34 weeks)</time_frame>
    <description>Measured in dose steps/day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of body weight</measure>
    <time_frame>From baseline [≤12 weeks prior to treatment initiation [week 0]) to end of study (26-34 weeks)</time_frame>
    <description>Measured in kg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in number of patient self-reported overall non-severe hypoglycaemic episodes based on recollection</measure>
    <time_frame>Pre- to post- initiation of treatment with Xultophy®. Episodes occurring within 4 weeks prior to initiation of treatment with Xultophy® and to within 4 weeks prior to end of study (26-34 weeks)</time_frame>
    <description>Number of episodes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in number of patient self-reported nocturnal non-severe hypoglycaemic episodes based on recollection</measure>
    <time_frame>Pre- to post- initiation of treatment with Xultophy®. Episodes occurring within 4 weeks prior to initiation of treatment with Xultophy® and to within 4 weeks prior to end of study (26-34 weeks)</time_frame>
    <description>Number of episodes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in number of patient self-reported severe hypoglycaemic episodes based on recollection (overall)</measure>
    <time_frame>Pre- to post- initiation of treatment with Xultophy®. Episodes occurring within 26 weeks prior to initiation of treatment with Xultophy® and to within 26 weeks prior to end of study (26-34 weeks)</time_frame>
    <description>Number of episodes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reason(s) for discontinuing treatment with Xultophy® during the treatment period, if applicable</measure>
    <time_frame>At the end of study (26-34 weeks)</time_frame>
    <description>Pre-specified response option(s)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">300</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Patients with type 2 diabetes (T2DM)</arm_group_label>
    <description>Patients with T2DM treated with any basal insulin or glucagon-Like peptide-1 receptor agonist (GLP-1 RA) (including once weekly GLP-1 RA) with/without oral antidiabetic drug (OAD) treatment, and with inadequate glycaemic control, for whom the physician had decided to intensify their treatment with Xultophy®</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Insulin degludec/liraglutide</intervention_name>
    <description>Patients will be treated with Insulin degludec/liraglutide (Xultophy®) at the treating physician's discretion and independent from the decision to include the patient in the study.</description>
    <arm_group_label>Patients with type 2 diabetes (T2DM)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects with Type 2 Diabetes&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed informed consent obtained before any study-related activities (study-related&#xD;
             activities are any procedure related to recording of data according to the protocol).&#xD;
&#xD;
          -  The decision to initiate treatment with commercially available Xultophy® 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 greater than or equal to 18 years at the time of signing informed&#xD;
             consent.&#xD;
&#xD;
          -  Diagnosed with type 2 diabetes and treated with basal insulin plus or minus oral&#xD;
             anti-diabetic drugs (OADs) or Glucagon-Like Peptide-1 Receptor Agonist (GLP-1 RA) plus&#xD;
             or minus OADs, except Xultophy®, for at least 12 weeks prior to informed consent and&#xD;
             initiation visit (visit 1).&#xD;
&#xD;
          -  Available and documented glycosylated haemoglobin A1c (HbA1c) value less than or equal&#xD;
             to 12 weeks prior to initiation of Xultophy® treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hypersensitivity to the active substance or to any of the excipients as specified in&#xD;
             the Xultophy® local label.&#xD;
&#xD;
          -  Previous participation in this study. Participation is defined as having given&#xD;
             informed consent in this study.&#xD;
&#xD;
          -  Female who is known pregnant, breast-feeding or intends to become pregnant.&#xD;
&#xD;
          -  Treated with Xultophy® previously.&#xD;
&#xD;
          -  Mental incapacity, unwillingness or language barriers precluding adequate&#xD;
             understanding or cooperation.&#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>AbuDhabi</city>
        <country>United Arab Emirates</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Ajman</city>
        <zip>4184</zip>
        <country>United Arab Emirates</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Dubai</city>
        <country>United Arab Emirates</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Arab Emirates</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>September 21, 2021</last_update_submitted>
  <last_update_submitted_qc>September 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 22, 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>Liraglutide</mesh_term>
    <mesh_term>Xultophy</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>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/NCT03823339
org study id: NN9068-4458
secondary id: U1111-1213-4338
nct id: NCT03823339
lead sponsor: 
has dmc: No
is fda regulated device: No
The purpose of the study is to collect information on how Xultophy® works in patients with
      type 2 diabetes. The participants will get Xultophy® as prescribed to them by the study
      doctor. The study will last for about 26-34 weeks. The participants will be asked questions
      about their health and their diabetes treatment as part of their normal study doctor's
      appointment.
observational model: Cohort
time perspective: Prospective
measure: Change in laboratory measured glycosylated haemoglobin A1c (HbA1c)
time frame: From baseline [≤12 weeks prior to treatment initiation [week 0]) to end of study (26-34 weeks)
description: Measured in % point
measure: Patients reached HbA1c less than 7% at end of study (Yes/No )
time frame: At the end of study visit (26-34 weeks)
description: Number of patients who achieved/not achieved HbA1c at end of study: <7.0%
measure: Change in laboratory measured fasting plasma glucose (FPG)
time frame: From baseline [≤12 weeks prior to treatment initiation [week 0]) to end of study (26-34 weeks)
description: Measured in mg/dL
measure: Average dose step of Xultophy® at end of the study
time frame: At the end of study (26-34 weeks)
description: Measured in dose steps/day
measure: Change of body weight
time frame: From baseline [≤12 weeks prior to treatment initiation [week 0]) to end of study (26-34 weeks)
description: Measured in kg
measure: Change in number of patient self-reported overall non-severe hypoglycaemic episodes based on recollection
time frame: Pre- to post- initiation of treatment with Xultophy®. Episodes occurring within 4 weeks prior to initiation of treatment with Xultophy® and to within 4 weeks prior to end of study (26-34 weeks)
description: Number of episodes
measure: Change in number of patient self-reported nocturnal non-severe hypoglycaemic episodes based on recollection
time frame: Pre- to post- initiation of treatment with Xultophy®. Episodes occurring within 4 weeks prior to initiation of treatment with Xultophy® and to within 4 weeks prior to end of study (26-34 weeks)
description: Number of episodes
measure: Change in number of patient self-reported severe hypoglycaemic episodes based on recollection (overall)
time frame: Pre- to post- initiation of treatment with Xultophy®. Episodes occurring within 26 weeks prior to initiation of treatment with Xultophy® and to within 26 weeks prior to end of study (26-34 weeks)
description: Number of episodes
measure: Reason(s) for discontinuing treatment with Xultophy® during the treatment period, if applicable
time frame: At the end of study (26-34 weeks)
description: Pre-specified response option(s)
arm group label: Patients with type 2 diabetes (T2DM)
description: Patients with T2DM treated with any basal insulin or glucagon-Like peptide-1 receptor agonist (GLP-1 RA) (including once weekly GLP-1 RA) with/without oral antidiabetic drug (OAD) treatment, and with inadequate glycaemic control, for whom the physician had decided to intensify their treatment with Xultophy®
intervention type: Drug
intervention name: Insulin degludec/liraglutide
description: Patients will be treated with Insulin degludec/liraglutide (Xultophy®) at the treating physician's discretion and independent from the decision to include the patient in the study.
arm group label: Patients with type 2 diabetes (T2DM)
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: 
facility: 
country: United Arab Emirates
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Liraglutide
mesh term: Xultophy
sharing ipd: Yes
ipd description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
ipd url: http://novonordisk-trials.com