<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/NCT02220296</url>
  </required_header>
  <id_info>
    <org_study_id>NN1438-4137</org_study_id>
    <secondary_id>2014-000071-70</secondary_id>
    <secondary_id>U1111-1151-9327</secondary_id>
    <nct_id>NCT02220296</nct_id>
  </id_info>
  <brief_title>A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous NNC0123-0338 in Healthy Subjects and in Subjects With Type 1 Diabetes Mellitus</brief_title>
  <official_title>A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous NNC0123-0338 in Healthy Subjects and in Subjects With Type 1 Diabetes Mellitus</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 purpose is to evaluate safety and tolerability of a&#xD;
      range of single doses of subcutaneous insulin 338.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 20, 2014</start_date>
  <completion_date type="Actual">March 31, 2015</completion_date>
  <primary_completion_date type="Actual">March 31, 2015</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of adverse events</measure>
    <time_frame>Day 1 - day 22</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of hypoglycaemic episodes</measure>
    <time_frame>Day 1 - day 22</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the serum insulin 338 concentration-time curve from zero to infinity</measure>
    <time_frame>Day 1- day 22</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum serum insulin 338 concentration observed</measure>
    <time_frame>Day 1- day 22</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time for maximum serum insulin 338 concentration</measure>
    <time_frame>Day 1- day 22</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2, the terminal half-life of insulin 338</measure>
    <time_frame>Day 1- day 22</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Healthy</condition>
  <condition>Diabetes</condition>
  <condition>Diabetes Mellitus, Type 1</condition>
  <arm_group>
    <arm_group_label>Part 1 insulin 338</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 1 placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2 insulin 338</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2 insulin glargine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Insulin 338</intervention_name>
    <description>Healthy subjects will receive a single dose of insulin 338 in ascending doses. Injected subcutaneously (under the skin).</description>
    <arm_group_label>Part 1 insulin 338</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>Healthy subjects will receive a single dose of placebo. Injected subcutaneously (under the skin).</description>
    <arm_group_label>Part 1 placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Insulin 338</intervention_name>
    <description>Subjects with type 1 DM will receive a single dose of insulin 338 in ascending doses. Injected subcutaneously (under the skin).</description>
    <arm_group_label>Part 2 insulin 338</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>insulin glargine</intervention_name>
    <description>Subjects with type 1 DM will receive 0.4 U/kg insulin glargine once daily for 4 days. Injected subcutaneously (under the skin).</description>
    <arm_group_label>Part 2 insulin glargine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Trial Part 1 (Healthy subjects):&#xD;
&#xD;
          -  Male subject&#xD;
&#xD;
          -  Age 18-55 (both inclusive) at the time of signing inform consent&#xD;
&#xD;
          -  Body mass index 19.0-29.9 kg/m^2 (both inclusive)&#xD;
&#xD;
          -  Trial Part 2 (Subjects with type 1 diabetes mellitus):&#xD;
&#xD;
          -  Male subject or female subject of non-child bearing potential. Non-child bearing&#xD;
             potential: being surgically sterilized (i.e. tubal ligation, bilateral oopherectomies&#xD;
             or hysterectomised) for more than 3 months or being postmenopausal (as defined by&#xD;
             amenorrhoea for at least 2 years prior to screening and documented by&#xD;
             follicle-stimulating hormone (FSH) 40 U/L)&#xD;
&#xD;
          -  Age 18-64 years (both inclusive) at the time of signing inform consent&#xD;
&#xD;
          -  Body mass index 19.0-29.9 kg/m^2 (both inclusive)&#xD;
&#xD;
          -  Type 1 diabetes mellitus (as diagnosed clinically) for 12 months or longer&#xD;
&#xD;
          -  Treated with multiple daily insulin injections or insulin pump treatment for 12 months&#xD;
             or longer&#xD;
&#xD;
          -  Glycated hemoglobin (HbA1c) 9.0% or less&#xD;
&#xD;
          -  Fasting C-peptide less than 0.3 nmol/L&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Trial Part 1 (healthy subjects):&#xD;
&#xD;
          -  History of, or presence of, cancer, diabetes mellitus or any clinically significant&#xD;
             cardiovascular, respiratory, metabolic (including dyslipidemia), renal, hepatic,&#xD;
             gastrointestinal, endocrinological, haematological, dermatological, venereal,&#xD;
             neurological, psychiatric diseases or other major disorders, as judged by the&#xD;
             investigator&#xD;
&#xD;
          -  Increased risk of thrombosis, e.g. subjects with a history of deep leg vein thrombosis&#xD;
             or family history of deep leg vein thrombosis, as judged by the investigator&#xD;
&#xD;
          -  Currently smoke more than 1 cigarette per day (or the equivalent for other tobacco&#xD;
             products) or smoking 1 cigarette or less per day and not considering being able to&#xD;
             refrain from smoking or refrain from use of other types of nicotine products (e.g.&#xD;
             such as chewing tobacco, nicotine gums) during the in-house periods&#xD;
&#xD;
          -  Trial Part 2 (subjects with type 1 diabetes mellitus):&#xD;
&#xD;
          -  History of, or presence of, cancer or any clinically significant respiratory,&#xD;
             metabolic, renal, hepatic, gastrointestinal, endocrinological (with the exception of&#xD;
             conditions associated with diabetes mellitus), haematological, dermatological,&#xD;
             venereal, neurological, psychiatric, other major disorders or personal and/or family&#xD;
             history of thromboembolism, as judged by the investigator&#xD;
&#xD;
          -  Increased risk of thrombosis, e.g. subjects with a history of deep leg vein thrombosis&#xD;
             or family history of deep leg vein thrombosis, as judged by the investigator&#xD;
&#xD;
          -  Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last&#xD;
             12 months) or hypoglycaemic unawareness as judged by the Investigator or&#xD;
             hospitalisation for diabetic ketoacidosis during the past 6 months before start of&#xD;
             this trial (screening)&#xD;
&#xD;
          -  Cardiac problems defined as: 1) decompensated heart failure (New York Heart&#xD;
             Association (NYHA) class III and IV) at any time, or 2) acute myocardial infarction at&#xD;
             any time, or 3) angina pectoris within the last 12 months before start of this trial&#xD;
             (screening)&#xD;
&#xD;
          -  Currently smoke more than 1 cigarette per day (or the equivalent for other tobacco&#xD;
             products) or smoking 1 cigarette or less per day and not considering being able to&#xD;
             refrain from smoking or refrain from use of other types of nicotine products (e.g.&#xD;
             such as chewing tobacco, nicotine gums) during the in-house periods.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 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>Neuss</city>
        <zip>41460</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>http://novonordisk-trials.com</url>
    <description>Clinical Trials at Novo Nordisk</description>
  </link>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>August 18, 2014</study_first_submitted>
  <study_first_submitted_qc>August 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 19, 2014</study_first_posted>
  <last_update_submitted>December 6, 2017</last_update_submitted>
  <last_update_submitted_qc>December 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 8, 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 Glargine</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/NCT02220296
org study id: NN1438-4137
secondary id: 2014-000071-70
secondary id: U1111-1151-9327
nct id: NCT02220296
lead sponsor: 
has dmc: No
This trial is conducted in Europe. The purpose is to evaluate safety and tolerability of a
      range of single doses of subcutaneous insulin 338.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Incidence of adverse events
time frame: Day 1 - day 22
measure: Incidence of hypoglycaemic episodes
time frame: Day 1 - day 22
measure: Area under the serum insulin 338 concentration-time curve from zero to infinity
time frame: Day 1- day 22
measure: Maximum serum insulin 338 concentration observed
time frame: Day 1- day 22
measure: Time for maximum serum insulin 338 concentration
time frame: Day 1- day 22
measure: t1/2, the terminal half-life of insulin 338
time frame: Day 1- day 22
arm group label: Part 1 insulin 338
arm group type: Experimental
arm group label: Part 1 placebo
arm group type: Placebo Comparator
arm group label: Part 2 insulin 338
arm group type: Experimental
arm group label: Part 2 insulin glargine
arm group type: Active Comparator
intervention type: Drug
intervention name: Insulin 338
description: Healthy subjects will receive a single dose of insulin 338 in ascending doses. Injected subcutaneously (under the skin).
arm group label: Part 1 insulin 338
intervention type: Drug
intervention name: placebo
description: Healthy subjects will receive a single dose of placebo. Injected subcutaneously (under the skin).
arm group label: Part 1 placebo
intervention type: Drug
intervention name: Insulin 338
description: Subjects with type 1 DM will receive a single dose of insulin 338 in ascending doses. Injected subcutaneously (under the skin).
arm group label: Part 2 insulin 338
intervention type: Drug
intervention name: insulin glargine
description: Subjects with type 1 DM will receive 0.4 U/kg insulin glargine once daily for 4 days. Injected subcutaneously (under the skin).
arm group label: Part 2 insulin glargine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Global Clinical Registry (GCR, 1452)
role: Study Director
affiliation: Novo Nordisk A/S
facility: 
country: Germany
url: http://novonordisk-trials.com
description: Clinical Trials at Novo Nordisk
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 Glargine