<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/NCT01704378</url>
  </required_header>
  <id_info>
    <org_study_id>BIASP-1386</org_study_id>
    <nct_id>NCT01704378</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Biphasic Insulin Aspart 30 FlexPen™ in Subjects With Type 2 Diabetes</brief_title>
  <official_title>A Multi-National, Multi-Centre, Open-Labelled Extension Study Assessing the Long-Term Safety of Biphasic Insulin Aspart 30 in NovoMix®30 FlexPen™ in Type 2 Diabetic Patients Previously Treated in BIAsp-1236</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 investigate the the long-term safety&#xD;
      of biphasic insulin aspart 30 in subjects with type 2 diabetes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 18, 2001</start_date>
  <completion_date type="Actual">March 14, 2003</completion_date>
  <primary_completion_date type="Actual">March 14, 2003</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Hypoglycaemic episodes</measure>
  </primary_outcome>
  <primary_outcome>
    <measure>Occurrence of adverse events</measure>
  </primary_outcome>
  <secondary_outcome>
    <measure>HbA1c (glycosylated haemoglobin)</measure>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prandial increment in blood glucose</measure>
  </secondary_outcome>
  <secondary_outcome>
    <measure>7-point blood glucose profile</measure>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">89</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>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>biphasic insulin aspart</intervention_name>
    <description>Individually adjusted dose. Injected subcutaneously (s.c., under the skin) twice daily before breakfast and evening meal</description>
    <arm_group_label>BIAsp</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed informed consent obtained before any trial-related activities&#xD;
&#xD;
          -  Completed the trial BIAsp-1236&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Planned changes in use of any prescription medication that may interfere with glucose&#xD;
             regulation&#xD;
&#xD;
          -  Known or suspected allergy to trial products or related products&#xD;
&#xD;
          -  Women who are having the intention of becoming pregnant, or are judged not to be using&#xD;
             adequate contraceptive measures&#xD;
&#xD;
          -  Any other significant condition or concomitant disease or any condition that would&#xD;
             interfere with participation as judged by the Investigator&#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>Kotka</city>
        <zip>48210</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kuopio</city>
        <zip>70210</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Lahti</city>
        <zip>15850</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Gjøvik</city>
        <zip>NO-2819</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Horten</city>
        <zip>NO-3188</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kirkenær</city>
        <zip>2260</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kongsvinger</city>
        <zip>2212</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Notodden</city>
        <zip>NO-3675</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Falun</city>
        <zip>791 82</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Helsingborg</city>
        <zip>254 43</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Motala</city>
        <zip>591 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Derby</city>
        <zip>DE7 1DY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Edinburgh</city>
        <zip>EH16 4SA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Hull</city>
        <zip>HU3 2JZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Liverpool</city>
        <zip>L7 8XP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Scarborough</city>
        <zip>YO12 6QL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Wirral, Merseyside</city>
        <zip>CH63 4JY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
    <country>Norway</country>
    <country>Sweden</country>
    <country>United Kingdom</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>October 8, 2012</study_first_submitted>
  <study_first_submitted_qc>October 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 11, 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 Aspart</mesh_term>
    <mesh_term>Biphasic Insulins</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/NCT01704378
org study id: BIASP-1386
nct id: NCT01704378
lead sponsor: 
has dmc: No
This trial is conducted in Europe. The aim of this trial investigate the the long-term safety
      of biphasic insulin aspart 30 in subjects with type 2 diabetes.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Hypoglycaemic episodes
measure: Occurrence of adverse events
measure: HbA1c (glycosylated haemoglobin)
measure: Prandial increment in blood glucose
measure: 7-point blood glucose profile
arm group label: BIAsp
arm group type: Experimental
intervention type: Drug
intervention name: biphasic insulin aspart
description: Individually adjusted dose. Injected subcutaneously (s.c., under the skin) twice daily before breakfast and evening meal
arm group label: BIAsp
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: 
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facility: 
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country: Finland
country: Norway
country: Sweden
country: United Kingdom
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 Aspart
mesh term: Biphasic Insulins