<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/NCT01707160</url>
  </required_header>
  <id_info>
    <org_study_id>ANA/DCD/031</org_study_id>
    <nct_id>NCT01707160</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 in Healthy Volunteers</brief_title>
  <official_title>A Randomised, Double-blind 2 Way Crossover Trial to Investigate the Pharmacokinetics and Pharmacodynamics of Insulin X14 30/70 PreMix Compared to Human Insulin 30/70 PreMix in Healthy 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 Europe. The aim of this trial is to investigate the&#xD;
      pharmacokinetics and pharmacodynamics of insulin X14 30/70 PreMix compared to human insulin&#xD;
      30/70 PreMix in healthy volunteers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 1995</start_date>
  <completion_date type="Actual">December 1995</completion_date>
  <primary_completion_date type="Actual">December 1995</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</measure>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum insulin concentration (Cmax)</measure>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to maximum insulin concentration (tmax)</measure>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimum glucose concentration (Cmin(glu))</measure>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to minimum glucose concentration (tmin(glu))</measure>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</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>Treatment period 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment period 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>biphasic insulin aspart 30</intervention_name>
    <description>One single dose of each trial drug separated by 4-10 days injected subcutaneously (s.c, under the skin) in random order</description>
    <arm_group_label>Treatment period 1</arm_group_label>
    <arm_group_label>Treatment period 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>biphasic human insulin 30</intervention_name>
    <description>One single dose of each trial drug separated by 4-10 days injected subcutaneously (s.c, under the skin) in random order</description>
    <arm_group_label>Treatment period 1</arm_group_label>
    <arm_group_label>Treatment period 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Non-smokers&#xD;
&#xD;
          -  BMI (body mass index) maximum 27 kg/m^2&#xD;
&#xD;
          -  HbA1c (glycosylated haemoglobin A1c): 3.4-6.1%&#xD;
&#xD;
          -  FBG (fasting blood glucose) maximum 6.0 mmol/L&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</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>Leeds</city>
        <zip>LS2 9NG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>http://novonordisk-trials.com</url>
    <description>Clinical Trials at Novo Nordisk</description>
  </link>
  <results_reference>
    <citation>Jacobsen LV, Sogaard B, Riis A. Pharmacokinetics and pharmacodynamics of a premixed formulation of soluble and protamine-retarded insulin aspart. Eur J Clin Pharmacol. 2000 Aug;56(5):399-403. doi: 10.1007/s002280000159.</citation>
    <PMID>11009049</PMID>
  </results_reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>October 10, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <last_update_submitted>January 3, 2017</last_update_submitted>
  <last_update_submitted_qc>January 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 4, 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</mesh_term>
    <mesh_term>Insulin, Globin Zinc</mesh_term>
    <mesh_term>Insulin Aspart</mesh_term>
    <mesh_term>Biphasic Insulins</mesh_term>
    <mesh_term>Insulin aspart, insulin aspart protamine drug combination 30:70</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/NCT01707160
org study id: ANA/DCD/031
nct id: NCT01707160
lead sponsor: 
has dmc: No
This trial is conducted in Europe. The aim of this trial is to investigate the
      pharmacokinetics and pharmacodynamics of insulin X14 30/70 PreMix compared to human insulin
      30/70 PreMix in healthy volunteers.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Area under the Curve
measure: Maximum insulin concentration (Cmax)
measure: Time to maximum insulin concentration (tmax)
measure: Minimum glucose concentration (Cmin(glu))
measure: Time to minimum glucose concentration (tmin(glu))
measure: Adverse events
arm group label: Treatment period 1
arm group type: Experimental
arm group label: Treatment period 2
arm group type: Active Comparator
intervention type: Drug
intervention name: biphasic insulin aspart 30
description: One single dose of each trial drug separated by 4-10 days injected subcutaneously (s.c, under the skin) in random order
arm group label: Treatment period 1
arm group label: Treatment period 2
intervention type: Drug
intervention name: biphasic human insulin 30
description: One single dose of each trial drug separated by 4-10 days injected subcutaneously (s.c, under the skin) in random order
arm group label: Treatment period 1
arm group label: Treatment period 2
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Global Clinical Registry (GCR,1452)
role: Study Director
affiliation: Novo Nordisk A/S
facility: 
country: United Kingdom
url: http://novonordisk-trials.com
description: Clinical Trials at Novo Nordisk
citation: Jacobsen LV, Sogaard B, Riis A. Pharmacokinetics and pharmacodynamics of a premixed formulation of soluble and protamine-retarded insulin aspart. Eur J Clin Pharmacol. 2000 Aug;56(5):399-403. doi: 10.1007/s002280000159.
PMID: 11009049
responsible party type: Sponsor
mesh term: Insulin
mesh term: Insulin, Globin Zinc
mesh term: Insulin Aspart
mesh term: Biphasic Insulins
mesh term: Insulin aspart, insulin aspart protamine drug combination 30:70