<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/NCT01697631</url>
  </required_header>
  <id_info>
    <org_study_id>BIASP-1409</org_study_id>
    <nct_id>NCT01697631</nct_id>
  </id_info>
  <brief_title>Glycemic Control of Biphasic Insulin Aspart 30 in Type 2 Diabetes</brief_title>
  <official_title>Comparison of Biphasic Insulin Aspart 30 Twice Daily and Biphasic Insulin Aspart 30 Twice Daily Plus Lunchtime Injection of Insulin Aspart Treatment Efficiency in Overall Glycemic Control and Postprandial Glycemic Excursions. A Multi-center, Randomized, Open-label, Two-armed Parallel Group Trial in Subjects With Type 2 Diabetes Previously Treated With Conventional Biphasic Human Insulin 30/70</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 this trial is conducted in Europe. The aim of this trial is to compare glycaemic control&#xD;
      of biphasic insulin aspart 30 (BIAsp 30) alone or combined with insulin aspart(IAsp) in&#xD;
      patients previously treated with conventional Biphasic Human Insulin 30/70.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 22, 2002</start_date>
  <completion_date type="Actual">April 24, 2003</completion_date>
  <primary_completion_date type="Actual">April 24, 2003</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>HbA1c (glycosylated haemoglobin)</measure>
  </primary_outcome>
  <secondary_outcome>
    <measure>7-point blood glucose profile</measure>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of endpoint HbA1c with baseline BMI (body mass index) and HbA1c with treatment mode stratification</measure>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events</measure>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypoglycaemic episodes (minor, major or nocturnal)</measure>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">131</enrollment>
  <condition>Diabetes</condition>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>BIAsp</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Insulin aspart</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>biphasic insulin aspart 30</intervention_name>
    <description>Administrated subcutaneously (s.c., under the skin) at breakfast and evening main meals</description>
    <arm_group_label>BIAsp</arm_group_label>
    <arm_group_label>Insulin aspart</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>insulin aspart</intervention_name>
    <description>Administrated subcutaneously (s.c., under the skin) before lunch</description>
    <arm_group_label>Insulin aspart</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Type 2 diabetes&#xD;
&#xD;
          -  Current treatment with conventional biphasic human insulin 30/70 b.i.d. (twice daily)&#xD;
             for at least 3 months&#xD;
&#xD;
          -  HbA1c (glycosylated haemoglobin) equal to or below 12%&#xD;
&#xD;
          -  Willing and able to perform self blood glucose monitoring (SMBG)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of drug or alcohol dependence&#xD;
&#xD;
          -  Mental incapacity, unwillingness or language barriers precluding adequate&#xD;
             understanding or co-operation&#xD;
&#xD;
          -  Previous participation in this trial&#xD;
&#xD;
          -  Receipt of any investigational drug within the last month prior to this trial&#xD;
&#xD;
          -  Known or suspected allergy to trial products or related products&#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>Bialystok</city>
        <zip>15-276</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Bytom</city>
        <zip>41-902</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kamieniec Zabkowicki</city>
        <zip>57-230</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Katowice</city>
        <zip>40-053</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Krakow</city>
        <zip>31-261</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Nysa</city>
        <zip>48-300</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Otwock</city>
        <zip>05-400</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Radom</city>
        <zip>26-600</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Ruda Slaska</city>
        <zip>41-700</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Sosnowiec</city>
        <zip>41-200</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Warsaw</city>
        <zip>01-877</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Wroclaw</city>
        <zip>50-306</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</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>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>February 22, 2017</last_update_submitted>
  <last_update_submitted_qc>February 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 24, 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>Insulin, Long-Acting</mesh_term>
    <mesh_term>Insulin degludec, insulin aspart drug combination</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/NCT01697631
org study id: BIASP-1409
nct id: NCT01697631
lead sponsor: 
has dmc: No
This this trial is conducted in Europe. The aim of this trial is to compare glycaemic control
      of biphasic insulin aspart 30 (BIAsp 30) alone or combined with insulin aspart(IAsp) in
      patients previously treated with conventional Biphasic Human Insulin 30/70.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: HbA1c (glycosylated haemoglobin)
measure: 7-point blood glucose profile
measure: Correlation of endpoint HbA1c with baseline BMI (body mass index) and HbA1c with treatment mode stratification
measure: Incidence of adverse events
measure: Hypoglycaemic episodes (minor, major or nocturnal)
arm group label: BIAsp
arm group type: Experimental
arm group label: Insulin aspart
arm group type: Experimental
intervention type: Drug
intervention name: biphasic insulin aspart 30
description: Administrated subcutaneously (s.c., under the skin) at breakfast and evening main meals
arm group label: BIAsp
arm group label: Insulin aspart
intervention type: Drug
intervention name: insulin aspart
description: Administrated subcutaneously (s.c., under the skin) before lunch
arm group label: Insulin aspart
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: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
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country: Poland
url: http://novonordisk-trials.com
description: Clinical Trials at Novo Nordisk
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: Insulin, Long-Acting
mesh term: Insulin degludec, insulin aspart drug combination
mesh term: Biphasic Insulins
mesh term: Insulin aspart, insulin aspart protamine drug combination 30:70