<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/NCT01709929</url>
  </required_header>
  <id_info>
    <org_study_id>NN304-1713</org_study_id>
    <nct_id>NCT01709929</nct_id>
  </id_info>
  <brief_title>Safety of Insulin Detemir for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes Mellitus</brief_title>
  <acronym>PREDICTIVE™</acronym>
  <official_title>A Multicentre, Open Label, Nonrandomised, Safety Study in Subjects Using Insulin Detemir for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes Mellitus</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial is conducted in North America. The aim of this trial is to evaluate the safety of&#xD;
      insulin detemir for the treatment of diabetes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2005</start_date>
  <completion_date type="Actual">April 2006</completion_date>
  <primary_completion_date type="Actual">April 2006</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of serious adverse drug reactions (SADRs) including major hypoglycaemic events</measure>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of adverse events (all and serious)</measure>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of all hypoglycaemic events</measure>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in weight</measure>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HbA1c (glycosylated haemoglobin)</measure>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment satisfaction as assessed by Insulin Treatment Satisfaction Questionnaire (ITSQ-22)</measure>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">2287</enrollment>
  <condition>Diabetes</condition>
  <condition>Diabetes Mellitus, Type 1</condition>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Insulin detemir</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>insulin detemir</intervention_name>
    <description>Administered subcutaneously (s.c., under the skin). Dose individually adjusted.</description>
    <arm_group_label>Insulin detemir</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with type 1 or type 2 diabetes&#xD;
&#xD;
          -  Using a basal/bolus insulin regimen&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude,&#xD;
             inability to return for the final visit&#xD;
&#xD;
          -  Subjects who previously enrolled in this study&#xD;
&#xD;
          -  Subjects with a hypersensitivity to insulin detemir or to any of the excipients&#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>Global Clinical Registry (GCR, 1452)</last_name>
    <role>Study Director</role>
    <affiliation>Novo Nordisk A/S</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Mississauga</city>
        <zip>L4W 4XI</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <link>
    <url>http://novonordisk-trials.com</url>
    <description>Clinical Trials at Novo Nordisk</description>
  </link>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>October 16, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 18, 2012</study_first_posted>
  <last_update_submitted>March 2, 2016</last_update_submitted>
  <last_update_submitted_qc>March 2, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 3, 2016</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>
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin Detemir</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01709929
org study id: NN304-1713
nct id: NCT01709929
lead sponsor: 
has dmc: No
This trial is conducted in North America. The aim of this trial is to evaluate the safety of
      insulin detemir for the treatment of diabetes.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of serious adverse drug reactions (SADRs) including major hypoglycaemic events
measure: Number of adverse events (all and serious)
measure: Number of all hypoglycaemic events
measure: Change in weight
measure: HbA1c (glycosylated haemoglobin)
measure: Treatment satisfaction as assessed by Insulin Treatment Satisfaction Questionnaire (ITSQ-22)
arm group label: Insulin detemir
arm group type: Experimental
intervention type: Drug
intervention name: insulin detemir
description: Administered subcutaneously (s.c., under the skin). Dose individually adjusted.
arm group label: Insulin detemir
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Global Clinical Registry (GCR, 1452)
role: Study Director
affiliation: Novo Nordisk A/S
facility: 
country: Canada
url: http://novonordisk-trials.com
description: Clinical Trials at Novo Nordisk
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Diabetes Mellitus, Type 1
mesh term: Insulin Detemir