<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/NCT01698697</url>
  </required_header>
  <id_info>
    <org_study_id>NN248-1494</org_study_id>
    <nct_id>NCT01698697</nct_id>
  </id_info>
  <brief_title>Comparison of Two Insulin Aspart Formulations in Healthy Volunteers</brief_title>
  <official_title>A Single Centre, Randomized, Balanced Double-blind, Cross-Over Trial Investigating the Bioequivalence of a Continuous Subcutaneous Infusion of a Marketed NovoRapid Formulation Containing 100 U/ml and a New NovoRapid Formulation Containing 200 U/ml in Healthy Male Volunteers</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 Africa. The aim of this trial is to determine if a new formulation&#xD;
      (U200) of insulin aspart containing 200 U/mL is bioequivalent to that of a marketed insulin&#xD;
      aspart formulation (U100).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2, 2002</start_date>
  <completion_date type="Actual">October 18, 2002</completion_date>
  <primary_completion_date type="Actual">October 18, 2002</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>Area under the curve (AUC)</measure>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the glucose infusion rate curve</measure>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cmax (maximum plasma concentration)</measure>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to reach maximum (tmax)</measure>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal half-life (t½)</measure>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of hypoglycemic events</measure>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GIRmax: The maximal GIR (glucose infusion rate)</measure>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Diabetes</condition>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>U100</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>U200</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>insulin aspart</intervention_name>
    <description>Bolus 0.1 U/kg administered simultaneously with a continuous infusion of 0.029 U/kg/h via a programmed insulin pump. A total dose of 0.35 U/kg is delivered to the subject in the 12 hour infusion</description>
    <arm_group_label>U100</arm_group_label>
    <arm_group_label>U200</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Normal findings in medical history and physical examination unless the investigator&#xD;
             considers any abnormality to be clinically irrelevant&#xD;
&#xD;
          -  Normal laboratory values, electrocardiogram (ECG), and vital signs unless the&#xD;
             investigator considers any abnormality to be clinically irrelevant&#xD;
&#xD;
          -  Body mass index (BMI) 18-26 kg/m^2 (both inclusive)&#xD;
&#xD;
          -  Weight 60-90 kg&#xD;
&#xD;
          -  Non-smoker&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any condition requiring the regular use of any medication&#xD;
&#xD;
          -  Known or suspected allergy to the trial product or related products&#xD;
&#xD;
          -  Family history of type 1 diabetes mellitus&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 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>Bloemfontein</city>
        <zip>9324</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>South Africa</country>
  </location_countries>
  <link>
    <url>http://novonordisk-trials.com</url>
    <description>Clinical Trials at Novo Nordisk</description>
  </link>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>September 28, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>February 28, 2017</last_update_submitted>
  <last_update_submitted_qc>February 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin Aspart</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/NCT01698697
org study id: NN248-1494
nct id: NCT01698697
lead sponsor: 
has dmc: No
This trial is conducted in Africa. The aim of this trial is to determine if a new formulation
      (U200) of insulin aspart containing 200 U/mL is bioequivalent to that of a marketed insulin
      aspart formulation (U100).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Area under the curve (AUC)
measure: Area under the glucose infusion rate curve
measure: Cmax (maximum plasma concentration)
measure: Time to reach maximum (tmax)
measure: Terminal half-life (t½)
measure: Incidence of hypoglycemic events
measure: Adverse events
measure: GIRmax: The maximal GIR (glucose infusion rate)
arm group label: U100
arm group type: Active Comparator
arm group label: U200
arm group type: Experimental
intervention type: Drug
intervention name: insulin aspart
description: Bolus 0.1 U/kg administered simultaneously with a continuous infusion of 0.029 U/kg/h via a programmed insulin pump. A total dose of 0.35 U/kg is delivered to the subject in the 12 hour infusion
arm group label: U100
arm group label: U200
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Global Clinical Registry (GCR, 1452)
role: Study Director
affiliation: Novo Nordisk A/S
facility: 
country: South Africa
url: http://novonordisk-trials.com
description: Clinical Trials at Novo Nordisk
responsible party type: Sponsor
mesh term: Insulin Aspart