<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/NCT01704417</url>
  </required_header>
  <id_info>
    <org_study_id>NN1250-3999</org_study_id>
    <secondary_id>2012-000329-37</secondary_id>
    <secondary_id>U1111-1127-3402</secondary_id>
    <nct_id>NCT01704417</nct_id>
  </id_info>
  <brief_title>A Trial Comparing the Effect of Exercise on Blood Glucose in Subjects With Type 1 Diabetes, Who Are Treated With Either Insulin Degludec or Insulin Glargine</brief_title>
  <official_title>A Trial Comparing the Effect of Exercise on Blood Glucose Between Insulin Degludec and Insulin Glargine in Subjects With Type 1 Diabetes</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 Europe. The aim of the trial is to compare the effect of exercise&#xD;
      on blood glucose in subjects with type 1 diabetes, who are treated with either insulin&#xD;
      degludec (IDeg) or insulin glargine (IGlar).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>BGpre-exe - BGminimum,exe, difference between blood glucose concentration before exercise and the minimum blood glucose concentration observed during exercise</measure>
    <time_frame>From 0 to 30 minutes</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>BGmean,exe, mean blood glucose concentration during exercise</measure>
    <time_frame>From 0 to 30 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BGmean,30-180min,post-exe, mean blood glucose concentration</measure>
    <time_frame>Between 30 and 180 minutes, i.e. post-exercise</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BGminimum,30-180min,post-exe, minimum blood glucose concentration</measure>
    <time_frame>Between 30 and 180 minutes, i.e. post-exercise</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Diabetes</condition>
  <condition>Diabetes Mellitus, Type 1</condition>
  <arm_group>
    <arm_group_label>IDeg followed by IGlar</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>IGlar followed by IDeg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>insulin degludec</intervention_name>
    <description>Subjects will be randomised to a treatment sequence consisting of two treatment periods in which the subjects will receive IDeg and IGlar, respectively. Administered subcutaneously (s.c., under the skin) once daily. Dose individually adjusted.</description>
    <arm_group_label>IDeg followed by IGlar</arm_group_label>
    <arm_group_label>IGlar followed by IDeg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>insulin glargine</intervention_name>
    <description>Subjects will be randomised to a treatment sequence consisting of two treatment periods in which the subjects will receive IDeg and IGlar, respectively. Administered subcutaneously (s.c., under the skin) once daily. Dose individually adjusted.</description>
    <arm_group_label>IDeg followed by IGlar</arm_group_label>
    <arm_group_label>IGlar followed by IDeg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months&#xD;
&#xD;
          -  Body mass index 18.0-27.0 kg/m^2 (both inclusive)&#xD;
&#xD;
          -  Subjects performing regular physical cardiorespiratory activity&#xD;
&#xD;
          -  Glycosylated haemoglobin (HbA1c) below or equal to 9.5 %&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject who has donated any blood or plasma in the past month or more than 500 mL&#xD;
             within 3 months prior to screening&#xD;
&#xD;
          -  Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent&#xD;
             per day)&#xD;
&#xD;
          -  Not able or willing to refrain from smoking and use of nicotine substitute products&#xD;
             during the inpatient period&#xD;
&#xD;
          -  Supine blood pressure at screening (after resting for at least 5 minutes) outside the&#xD;
             range of 90-140 mmHg for systolic or 50-90 mmHg for diastolic&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</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>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Neuss</city>
        <zip>41460</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>http://novonordisk-trials.com</url>
    <description>Clinical Trials at Novo Nordisk</description>
  </link>
  <results_reference>
    <citation>Heise T, Bain SC, Bracken RM, Zijlstra E, Nosek L, Stender-Petersen K, Rabol R, Rowe E, Haahr HL. Similar risk of exercise-related hypoglycaemia for insulin degludec to that for insulin glargine in patients with type 1 diabetes: a randomized cross-over trial. Diabetes Obes Metab. 2016 Feb;18(2):196-9. doi: 10.1111/dom.12588. Epub 2015 Nov 27.</citation>
    <PMID>26450456</PMID>
  </results_reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>October 8, 2012</study_first_submitted>
  <study_first_submitted_qc>October 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 11, 2012</study_first_posted>
  <last_update_submitted>December 15, 2016</last_update_submitted>
  <last_update_submitted_qc>December 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 16, 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 1</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin</mesh_term>
    <mesh_term>Insulin, Globin Zinc</mesh_term>
    <mesh_term>Insulin Glargine</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/NCT01704417
org study id: NN1250-3999
secondary id: 2012-000329-37
secondary id: U1111-1127-3402
nct id: NCT01704417
lead sponsor: 
has dmc: No
This trial is conducted in Europe. The aim of the trial is to compare the effect of exercise
      on blood glucose in subjects with type 1 diabetes, who are treated with either insulin
      degludec (IDeg) or insulin glargine (IGlar).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: BGpre-exe - BGminimum,exe, difference between blood glucose concentration before exercise and the minimum blood glucose concentration observed during exercise
time frame: From 0 to 30 minutes
measure: BGmean,exe, mean blood glucose concentration during exercise
time frame: From 0 to 30 minutes
measure: BGmean,30-180min,post-exe, mean blood glucose concentration
time frame: Between 30 and 180 minutes, i.e. post-exercise
measure: BGminimum,30-180min,post-exe, minimum blood glucose concentration
time frame: Between 30 and 180 minutes, i.e. post-exercise
arm group label: IDeg followed by IGlar
arm group type: Experimental
arm group label: IGlar followed by IDeg
arm group type: Experimental
intervention type: Drug
intervention name: insulin degludec
description: Subjects will be randomised to a treatment sequence consisting of two treatment periods in which the subjects will receive IDeg and IGlar, respectively. Administered subcutaneously (s.c., under the skin) once daily. Dose individually adjusted.
arm group label: IDeg followed by IGlar
arm group label: IGlar followed by IDeg
intervention type: Drug
intervention name: insulin glargine
description: Subjects will be randomised to a treatment sequence consisting of two treatment periods in which the subjects will receive IDeg and IGlar, respectively. Administered subcutaneously (s.c., under the skin) once daily. Dose individually adjusted.
arm group label: IDeg followed by IGlar
arm group label: IGlar followed by IDeg
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Global Clinical Registry (GCR, 1452)
role: Study Director
affiliation: Novo Nordisk A/S
facility: 
country: Germany
url: http://novonordisk-trials.com
description: Clinical Trials at Novo Nordisk
citation: Heise T, Bain SC, Bracken RM, Zijlstra E, Nosek L, Stender-Petersen K, Rabol R, Rowe E, Haahr HL. Similar risk of exercise-related hypoglycaemia for insulin degludec to that for insulin glargine in patients with type 1 diabetes: a randomized cross-over trial. Diabetes Obes Metab. 2016 Feb;18(2):196-9. doi: 10.1111/dom.12588. Epub 2015 Nov 27.
PMID: 26450456
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
mesh term: Insulin
mesh term: Insulin, Globin Zinc
mesh term: Insulin Glargine