<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/NCT01697618</url>
  </required_header>
  <id_info>
    <org_study_id>ANA/DCD/046</org_study_id>
    <nct_id>NCT01697618</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics, Pharmacodynamics and Safety of Biphasic Insulin Aspart 30 in Type 2 Diabetes</brief_title>
  <official_title>A Randomised, Double-blind, Single Centre, Two-way Cross-over Trial Comparing the Pharmacokinetics, Pharmacodynamics and Safety of the Biphasic Insulin Aspart 30 and Insulin Mixtard 30/70 After Multiple Dosing With a Twice Daily Dose Regimen in Type 2 Diabetic Patients</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 pharmacokinetics,&#xD;
      pharmacodynamics and safety of biphasic insulin aspart 30 in subjects with type 2 diabetes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 1997</start_date>
  <completion_date type="Actual">November 1998</completion_date>
  <primary_completion_date type="Actual">November 1998</primary_completion_date>
  <phase>Phase 2</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 serum insulin curve</measure>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall shape of the 24 hour serum insulin profile</measure>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax (maximum plasma concentration)</measure>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tmax (time to reach maximum)</measure>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the curve following each injections derived from 24 hours serum insulin profiles</measure>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall shape of the 24 hour serum glucose profile</measure>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum glucose excursions (EXC)</measure>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Diabetes</condition>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>BIAsp 30</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>BHI 30</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>Injected subcutaneously (s.c., under the skin) before breakfast and dinner, dosage adjusted throughout the trial according to individual needs</description>
    <arm_group_label>BHI 30</arm_group_label>
    <arm_group_label>BIAsp 30</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>biphasic human insulin 30</intervention_name>
    <description>Injected subcutaneously (s.c., under the skin) before breakfast and dinner, dosage adjusted throughout the trial according to individual needs</description>
    <arm_group_label>BHI 30</arm_group_label>
    <arm_group_label>BIAsp 30</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Type 2 diabetes for at least 12 months&#xD;
&#xD;
          -  Treated with a combination of soluble/protracted human insulin in the ratio of 30/70&#xD;
             in a twice-daily regimen for at least 6 months&#xD;
&#xD;
          -  BMI (body mass index) below 39 kg/m^2&#xD;
&#xD;
          -  HbA1c (glycosylated haemoglobin) below 12%&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 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>Alphen a/d Rijn</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Crawley</city>
        <zip>RH11 9RT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>http://novonordisk-trials.com</url>
    <description>Clinical Trials at Novo Nordisk</description>
  </link>
  <results_reference>
    <citation>McSorley PT, Bell PM, Jacobsen LV, Kristensen A, Lindholm A. Twice-daily biphasic insulin aspart 30 versus biphasic human insulin 30: a double-blind crossover study in adults with type 2 diabetes mellitus. Clin Ther. 2002 Apr;24(4):530-9. doi: 10.1016/s0149-2918(02)85129-3.</citation>
    <PMID>12017398</PMID>
  </results_reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>September 28, 2012</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 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>
  <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>
  </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>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/NCT01697618
org study id: ANA/DCD/046
nct id: NCT01697618
lead sponsor: 
has dmc: No
This trial is conducted in Europe. The aim of this trial is to investigate pharmacokinetics,
      pharmacodynamics and safety of biphasic insulin aspart 30 in subjects with type 2 diabetes.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Area under the serum insulin curve
measure: Overall shape of the 24 hour serum insulin profile
measure: Cmax (maximum plasma concentration)
measure: tmax (time to reach maximum)
measure: Area under the curve following each injections derived from 24 hours serum insulin profiles
measure: Overall shape of the 24 hour serum glucose profile
measure: Serum glucose excursions (EXC)
arm group label: BIAsp 30
arm group type: Experimental
arm group label: BHI 30
arm group type: Active Comparator
intervention type: Drug
intervention name: biphasic insulin aspart 30
description: Injected subcutaneously (s.c., under the skin) before breakfast and dinner, dosage adjusted throughout the trial according to individual needs
arm group label: BHI 30
arm group label: BIAsp 30
intervention type: Drug
intervention name: biphasic human insulin 30
description: Injected subcutaneously (s.c., under the skin) before breakfast and dinner, dosage adjusted throughout the trial according to individual needs
arm group label: BHI 30
arm group label: BIAsp 30
criteria: 
gender: All
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: No
last name: Global Clinical Registry (GCR,1452)
role: Study Director
affiliation: Novo Nordisk A/S
facility: 
facility: 
country: Netherlands
country: United Kingdom
url: http://novonordisk-trials.com
description: Clinical Trials at Novo Nordisk
citation: McSorley PT, Bell PM, Jacobsen LV, Kristensen A, Lindholm A. Twice-daily biphasic insulin aspart 30 versus biphasic human insulin 30: a double-blind crossover study in adults with type 2 diabetes mellitus. Clin Ther. 2002 Apr;24(4):530-9. doi: 10.1016/s0149-2918(02)85129-3.
PMID: 12017398
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
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