<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/NCT01707134</url>
  </required_header>
  <id_info>
    <org_study_id>ANA/DCD/050</org_study_id>
    <nct_id>NCT01707134</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Insulin Aspart in Subjects With Type 1 Diabetes</brief_title>
  <official_title>An Open-labelled, Controlled, Multicentre, Multinational, Extension Study Assessing Safety and Efficacy of the Human Insulin Analogue Insulin Aspart (X14) and Human Soluble Insulin as Meal Related Insulin in a Multiple Injection Regimen in Type 1 Diabetic Subjects</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 evaluate the safety profile of&#xD;
      insulin aspart in subjects with type 1 diabetes having participated in trial ANA/DCD/035.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 1997</start_date>
  <completion_date type="Actual">May 2000</completion_date>
  <primary_completion_date type="Actual">May 2000</primary_completion_date>
  <phase>Phase 3</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>Number of hypoglycaemic events</measure>
  </primary_outcome>
  <secondary_outcome>
    <measure>Occurrence of adverse events</measure>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of hypoglycaemic episodes</measure>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Standard safety parameters: Haematology and biochemistry</measure>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HbA1c (glycosylated haemoglobin)</measure>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">753</enrollment>
  <condition>Diabetes</condition>
  <condition>Diabetes Mellitus, Type 1</condition>
  <arm_group>
    <arm_group_label>insulin aspart</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>human insulin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>insulin aspart</intervention_name>
    <description>Injected subcutaneously (s.c, under the skin) as meal time insulin</description>
    <arm_group_label>insulin aspart</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>human soluble insulin</intervention_name>
    <description>Injected subcutaneously (s.c, under the skin) as meal time insulin</description>
    <arm_group_label>human insulin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>insulin NPH</intervention_name>
    <description>Will be administrated subcutaneously (s.c, under the skin) once or twice daily as basal insulin</description>
    <arm_group_label>human insulin</arm_group_label>
    <arm_group_label>insulin aspart</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The subject must have completed the six month controlled treatment period in trial&#xD;
             ANA/DCD/035&#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>Graz</city>
        <zip>8036</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Wien</city>
        <zip>1030</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Wien</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Frederiksberg</city>
        <zip>2000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Gentofte</city>
        <zip>2820</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kolding</city>
        <zip>6000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>København</city>
        <zip>2400</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Køge</city>
        <zip>4600</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Helsinki</city>
        <zip>00029</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <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>Vantaa</city>
        <zip>01400</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Bad Neuenahr-Ahrweiler</city>
        <zip>53474</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Bad Oeynhausen</city>
        <zip>32454</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Bochum</city>
        <zip>44789</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Essen</city>
        <zip>45131</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Essen</city>
        <zip>45138</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Flensburg</city>
        <zip>24939</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Frankfurt</city>
        <zip>60590</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Freiburg</city>
        <zip>79106</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Friedrichsthal</city>
        <zip>66299</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Giessen</city>
        <zip>35385</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Haan</city>
        <zip>42781</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Hamburg</city>
        <zip>20251</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kiel</city>
        <zip>24103</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Magdeburg</city>
        <zip>39120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Magdeburg</city>
        <zip>39124</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Mainz</city>
        <zip>55116</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Mainz</city>
        <zip>55131</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Mönchengladbach</city>
        <zip>41061</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>München</city>
        <zip>81925</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Oberhausen</city>
        <zip>46145</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Ostercappeln</city>
        <zip>49179</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Saarlouis</city>
        <zip>66740</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Schwerin</city>
        <zip>19049</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Stuttgart</city>
        <zip>70184</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Stuttgart</city>
        <zip>70191</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Wiesbaden</city>
        <zip>65191</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Wuppertal</city>
        <zip>42117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Würzburg</city>
        <zip>97070</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Bergen</city>
        <zip>5021</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Haugesund</city>
        <zip>5500</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Oslo</city>
        <zip>0407</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Stavanger</city>
        <zip>4011</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Trondheim</city>
        <zip>7006</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>Karlstad</city>
        <zip>651 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Zürich</city>
        <zip>8032</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Airdrie</city>
        <zip>ML6 0JS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Bath</city>
        <zip>BA1 3NG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Blackburn</city>
        <zip>BB3 3LR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Bolton</city>
        <zip>BL1 4QS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Church Village</city>
        <zip>CF38 1AB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Cosham</city>
        <zip>PO6 3LY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Coventry</city>
        <zip>CV1 4FH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
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  <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>Edinburgh</city>
        <zip>EH4 2XU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Exeter</city>
        <zip>EX2 5AX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Gillingham</city>
        <zip>ME7 5NY</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>
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    </facility>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
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        <zip>IV2 3UJ</zip>
        <country>United Kingdom</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
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        <zip>LE1 5WW</zip>
        <country>United Kingdom</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>London</city>
        <zip>E1 1BB</zip>
        <country>United Kingdom</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
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        <zip>TS5 5AZ</zip>
        <country>United Kingdom</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Newcastle</city>
        <zip>NE7 7DN</zip>
        <country>United Kingdom</country>
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    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Northampton</city>
        <zip>NN1 5BD</zip>
        <country>United Kingdom</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
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        <zip>NG7 2UH</zip>
        <country>United Kingdom</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Penarth</city>
        <zip>CF64 2XX</zip>
        <country>United Kingdom</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Plymouth</city>
        <zip>PL8 8DQ</zip>
        <country>United Kingdom</country>
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    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Reading</city>
        <zip>RG51 5BS</zip>
        <country>United Kingdom</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Rugby</city>
        <zip>CV22 5PX</zip>
        <country>United Kingdom</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Salisbury</city>
        <zip>SP2 8BJ</zip>
        <country>United Kingdom</country>
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    </facility>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Sheffield</city>
        <zip>S5 7AU</zip>
        <country>United Kingdom</country>
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    </facility>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Southampton</city>
        <zip>SO14 OYG</zip>
        <country>United Kingdom</country>
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    </facility>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Stevenage</city>
        <zip>SG1 4AB</zip>
        <country>United Kingdom</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Stirling</city>
        <zip>FK8 2AU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Swansea</city>
        <zip>SA6 6NL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Watford</city>
        <zip>WD18 0HB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Whiston</city>
        <zip>L35 5DR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>York</city>
        <zip>YO3 7HE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Denmark</country>
    <country>Finland</country>
    <country>Germany</country>
    <country>Norway</country>
    <country>Sweden</country>
    <country>Switzerland</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>Home PD, Hallgren P, Usadel KH, Sane T, Faber J, Grill V, Friberg HH. Pre-meal insulin aspart compared with pre-meal soluble human insulin in type 1 diabetes. Diabetes Res Clin Pract. 2006 Feb;71(2):131-9. doi: 10.1016/j.diabres.2005.05.015. Epub 2005 Jul 27.</citation>
    <PMID>16054266</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>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 1</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>Isophane Insulin, Human</mesh_term>
    <mesh_term>Insulin, Isophane</mesh_term>
    <mesh_term>Isophane insulin, beef</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/NCT01707134
org study id: ANA/DCD/050
nct id: NCT01707134
lead sponsor: 
has dmc: No
This trial is conducted in Europe. The aim of this trial is to evaluate the safety profile of
      insulin aspart in subjects with type 1 diabetes having participated in trial ANA/DCD/035.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of hypoglycaemic events
measure: Occurrence of adverse events
measure: Incidence of hypoglycaemic episodes
measure: Standard safety parameters: Haematology and biochemistry
measure: HbA1c (glycosylated haemoglobin)
arm group label: insulin aspart
arm group type: Experimental
arm group label: human insulin
arm group type: Active Comparator
intervention type: Drug
intervention name: insulin aspart
description: Injected subcutaneously (s.c, under the skin) as meal time insulin
arm group label: insulin aspart
intervention type: Drug
intervention name: human soluble insulin
description: Injected subcutaneously (s.c, under the skin) as meal time insulin
arm group label: human insulin
intervention type: Drug
intervention name: insulin NPH
description: Will be administrated subcutaneously (s.c, under the skin) once or twice daily as basal insulin
arm group label: human insulin
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
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country: Austria
country: Denmark
country: Finland
country: Germany
country: Norway
country: Sweden
country: Switzerland
country: United Kingdom
url: http://novonordisk-trials.com
description: Clinical Trials at Novo Nordisk
citation: Home PD, Hallgren P, Usadel KH, Sane T, Faber J, Grill V, Friberg HH. Pre-meal insulin aspart compared with pre-meal soluble human insulin in type 1 diabetes. Diabetes Res Clin Pract. 2006 Feb;71(2):131-9. doi: 10.1016/j.diabres.2005.05.015. Epub 2005 Jul 27.
PMID: 16054266
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
mesh term: Insulin
mesh term: Insulin, Globin Zinc
mesh term: Insulin Aspart
mesh term: Isophane Insulin, Human
mesh term: Insulin, Isophane
mesh term: Isophane insulin, beef