<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/NCT01682902</url>
  </required_header>
  <id_info>
    <org_study_id>NN1218-3930</org_study_id>
    <secondary_id>U1111-1121-5106</secondary_id>
    <nct_id>NCT01682902</nct_id>
  </id_info>
  <brief_title>A Randomised Trial Evaluating Continuous Subcutaneous Infusion of Formulations of NN1218 and NovoLog® in Subjects With Type 1 Diabetes</brief_title>
  <official_title>A Randomised Trial Evaluating Continuous Subcutaneous Infusion of Formulations of NN1218 and NovoLog® 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 the United States of America (USA). The aim of the trial is to&#xD;
      evaluate continuous subcutaneous infusion of NN1218 formulations and NovoLog® in subjects&#xD;
      with type 1 diabetes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean change in plasma glucose concentration</measure>
    <time_frame>From 0-2 hours after administration of standardised meal after the first, the second, and the third 14-day treatment period</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self-measured plasma glucose (SMPG) 7-point profile</measure>
    <time_frame>After the first, the second, and the third 14-day treatment period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-measured plasma glucose (SMPG) 9-point profile</measure>
    <time_frame>After the first, the second, and the third 14-day treatment period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of adverse events (AEs) (including infusion site reactions/infections)</measure>
    <time_frame>Days 0-14 for each treatment periods</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of hypoglycaemic episodes</measure>
    <time_frame>Days 0-14 for each treatment period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of unexplained self-reported episodes of hypoglycaemia or hyperglycaemia (confirmed by SMPG)</measure>
    <time_frame>Days 0-14 for each treatment period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of episodes of infusion set occlusions</measure>
    <time_frame>Days 0-14 for each treatment period</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">43</enrollment>
  <condition>Diabetes</condition>
  <condition>Diabetes Mellitus, Type 1</condition>
  <arm_group>
    <arm_group_label>Formulation 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Formulation 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Insulin aspart (NovoLog®)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Faster-acting insulin aspart</intervention_name>
    <description>Administration: Subcutaneous infusion. The subjects will remain on their own pump during the trial. Subjects will have blinded continuous glucose monitoring (CGM) throughout the trial (3 treatment periods of 14 days) and meal tests consisting of a standardised breakfast (liquid meal) will be performed on the 14th day of each treatment period.</description>
    <arm_group_label>Formulation 1</arm_group_label>
    <other_name>NN1218</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Faster-acting insulin aspart</intervention_name>
    <description>Administration: Subcutaneous infusion. The subjects will remain on their own pump during the trial. Subjects will have blinded continuous glucose monitoring (CGM) throughout the trial (3 treatment periods of 14 days) and meal tests consisting of a standardised breakfast (liquid meal) will be performed on the 14th day of each treatment period.</description>
    <arm_group_label>Formulation 2</arm_group_label>
    <other_name>NN1218</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>insulin aspart</intervention_name>
    <description>Administration: Subcutaneous infusion. The subjects will remain on their own pump during the trial. Subjects will have blinded continuous glucose monitoring (CGM) throughout the trial (3 treatment periods of 14 days) and meal tests consisting of a standardised breakfast (liquid meal) will be performed on the 14th day of each treatment period.</description>
    <arm_group_label>Insulin aspart (NovoLog®)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Type 1 diabetes mellitus (diagnosed clinically) for at least 12 months prior to the&#xD;
             screening visit (Visit 1)&#xD;
&#xD;
          -  Treatment with the same insulin analogue by CSII (continuous subcutaneous insulin&#xD;
             infusion) for the previous 3 months prior to the screening visit (Visit 1)&#xD;
&#xD;
          -  Using a MiniMed Paradigm® pump (515/715, 522/722 or 523/723) for the previous 6 months&#xD;
             prior to the screening visit (Visit 1)&#xD;
&#xD;
          -  Glycosylated haemoglobin (HbA1c) below or equal to 9.0% by central laboratory&#xD;
&#xD;
          -  Body Mass Index (BMI) below or equal to 35.0 kg/m^2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of diabetic ketoacidsosis (DKA) episodes requiring hospitalization within 6&#xD;
             months prior to the screening visit (Visit 1)&#xD;
&#xD;
          -  History of abscess at the infusion site within 6 months prior to the screening visit&#xD;
             (Visit 1)&#xD;
&#xD;
          -  Hypoglycaemic unawareness as judged by the Investigator or history of severe&#xD;
             hypoglycaemic episodes requiring hospitalization within the last 6 months prior to the&#xD;
             screening visit (Visit 1)&#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>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30318</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://novonordisk-trials.com</url>
    <description>Clinical Trials at Novo Nordisk</description>
  </link>
  <results_reference>
    <citation>Bode BW, Johnson JA, Hyveled L, Tamer SC, Demissie M. Improved Postprandial Glycemic Control with Faster-Acting Insulin Aspart in Patients with Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion. Diabetes Technol Ther. 2017 Jan;19(1):25-33. doi: 10.1089/dia.2016.0350. Epub 2017 Jan 5.</citation>
    <PMID>28055230</PMID>
  </results_reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>August 31, 2012</study_first_submitted>
  <study_first_submitted_qc>September 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2012</study_first_posted>
  <last_update_submitted>January 6, 2017</last_update_submitted>
  <last_update_submitted_qc>January 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 9, 2017</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 Aspart</mesh_term>
    <mesh_term>Insulin, Long-Acting</mesh_term>
    <mesh_term>Insulin degludec, insulin aspart drug combination</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/NCT01682902
org study id: NN1218-3930
secondary id: U1111-1121-5106
nct id: NCT01682902
lead sponsor: 
has dmc: No
This trial is conducted in the United States of America (USA). The aim of the trial is to
      evaluate continuous subcutaneous infusion of NN1218 formulations and NovoLog® in subjects
      with type 1 diabetes.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Mean change in plasma glucose concentration
time frame: From 0-2 hours after administration of standardised meal after the first, the second, and the third 14-day treatment period
measure: Self-measured plasma glucose (SMPG) 7-point profile
time frame: After the first, the second, and the third 14-day treatment period
measure: Self-measured plasma glucose (SMPG) 9-point profile
time frame: After the first, the second, and the third 14-day treatment period
measure: Number of adverse events (AEs) (including infusion site reactions/infections)
time frame: Days 0-14 for each treatment periods
measure: Number of hypoglycaemic episodes
time frame: Days 0-14 for each treatment period
measure: Number of unexplained self-reported episodes of hypoglycaemia or hyperglycaemia (confirmed by SMPG)
time frame: Days 0-14 for each treatment period
measure: Number of episodes of infusion set occlusions
time frame: Days 0-14 for each treatment period
arm group label: Formulation 1
arm group type: Experimental
arm group label: Formulation 2
arm group type: Experimental
arm group label: Insulin aspart (NovoLog®)
arm group type: Active Comparator
intervention type: Drug
intervention name: Faster-acting insulin aspart
description: Administration: Subcutaneous infusion. The subjects will remain on their own pump during the trial. Subjects will have blinded continuous glucose monitoring (CGM) throughout the trial (3 treatment periods of 14 days) and meal tests consisting of a standardised breakfast (liquid meal) will be performed on the 14th day of each treatment period.
arm group label: Formulation 1
other name: NN1218
intervention type: Drug
intervention name: Faster-acting insulin aspart
description: Administration: Subcutaneous infusion. The subjects will remain on their own pump during the trial. Subjects will have blinded continuous glucose monitoring (CGM) throughout the trial (3 treatment periods of 14 days) and meal tests consisting of a standardised breakfast (liquid meal) will be performed on the 14th day of each treatment period.
arm group label: Formulation 2
other name: NN1218
intervention type: Drug
intervention name: insulin aspart
description: Administration: Subcutaneous infusion. The subjects will remain on their own pump during the trial. Subjects will have blinded continuous glucose monitoring (CGM) throughout the trial (3 treatment periods of 14 days) and meal tests consisting of a standardised breakfast (liquid meal) will be performed on the 14th day of each treatment period.
arm group label: Insulin aspart (NovoLog®)
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: United States
url: http://novonordisk-trials.com
description: Clinical Trials at Novo Nordisk
citation: Bode BW, Johnson JA, Hyveled L, Tamer SC, Demissie M. Improved Postprandial Glycemic Control with Faster-Acting Insulin Aspart in Patients with Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion. Diabetes Technol Ther. 2017 Jan;19(1):25-33. doi: 10.1089/dia.2016.0350. Epub 2017 Jan 5.
PMID: 28055230
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 Aspart
mesh term: Insulin, Long-Acting
mesh term: Insulin degludec, insulin aspart drug combination