<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/NCT04482725</url>
  </required_header>
  <id_info>
    <org_study_id>NN9838-4703</org_study_id>
    <secondary_id>U1111-1250-7817</secondary_id>
    <nct_id>NCT04482725</nct_id>
  </id_info>
  <brief_title>Injection Site Pain Comparison of Excipient Solutions</brief_title>
  <official_title>A Trial to Assess the Injection Site Pain Experience of Excipient Solutions Relevant for Subcutaneous Injection</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate different solutions used to inject drugs under&#xD;
      the skin. The solutions used in the study do not contain the drugs they will be used for, but&#xD;
      they do contain excipients, which are inactive substances added to drug solutions to ensure&#xD;
      the stability (shelf life and correct activity) of the drug product. The excipients are&#xD;
      considered 'inactive substances' compared to the drug, but they may cause an undesirable&#xD;
      effect at the injection site in the form of pain. However, their pain-causing potential has&#xD;
      never been tested in a systematic way. The purpose of the study is to determine if there is a&#xD;
      difference in the injection site pain experience after an injection under the skin&#xD;
      (subcutaneous) with 12 different study products. These study products are excipient&#xD;
      solutions, which are substances in medications next to the active substance. None of the 12&#xD;
      products include active medication. This study will be performed in 108 healthy male and&#xD;
      female volunteers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 20, 2020</start_date>
  <completion_date type="Actual">September 25, 2020</completion_date>
  <primary_completion_date type="Actual">September 24, 2020</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>Sequential Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intensity of injection site pain</measure>
    <time_frame>1 min after each injection (Day 1 and Day 2)</time_frame>
    <description>mm on a 100 mm horizontal visual-analogue scale (where 0 mm&#xD;
= no pain, 100 mm = unbearable pain)</description>
  </primary_outcome>
  <number_of_arms>12</number_of_arms>
  <enrollment type="Actual">108</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>S1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Day 1: Trial products 1-2-12-3-11-4 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.&#xD;
Day 2: Trial products 10-5-9-6-8-7 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>S2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Day 1: Trial products 2-3-1-4-12-5 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.&#xD;
Day 2: Trial products 11-6-10-7-9-8 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>S3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Day 1: Trial products 3-4-2-5-1-6 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.&#xD;
Day 2: Trial products 12-7-11-8-10-9 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>S4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Day 1: Trial products 4-5-3-6-2-7 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.&#xD;
Day 2: Trial products 1-8-12-9-11-10 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>S5</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Day 1: Trial products 5-6-4-7-3-8 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.&#xD;
Day 2: Trial products 2-9-1-10-12-11 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>S6</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Day 1: Trial products 6-7-5-8-4-9 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.&#xD;
Day 2: Trial products 3-10-2-11-1-12 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>S7</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Day 1: Trial products 7-8-6-9-5-10 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.&#xD;
Day 2: Trial products 4-11-3-12-2-1-given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>S8</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Day 1: Trial products 8-9-7-10-6-11 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.&#xD;
Day 2: Trial products 5-12-4-1-3-2 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>S9</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Day 1: Trial products 9-10-8-11-7-12 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.&#xD;
Day 2: Trial products 6-1-5-2-4-3 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>S10</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Day 1: Trial products 10-11-9-12-8-1 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.&#xD;
Day 2: Trial products 7-2-6-3-5-4 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>S11</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Day 1: Trial products 11-12-10-1-9-2 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.&#xD;
Day 2: Trial products 8-3-7-4-6-5 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>S12</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Day 1: Trial products 12-1-11-2-10-3 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.&#xD;
Day 2: Trial products 9-4-8-5-7-6 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Trial product 1</intervention_name>
    <description>Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL</description>
    <arm_group_label>S1</arm_group_label>
    <arm_group_label>S10</arm_group_label>
    <arm_group_label>S11</arm_group_label>
    <arm_group_label>S12</arm_group_label>
    <arm_group_label>S2</arm_group_label>
    <arm_group_label>S3</arm_group_label>
    <arm_group_label>S4</arm_group_label>
    <arm_group_label>S5</arm_group_label>
    <arm_group_label>S6</arm_group_label>
    <arm_group_label>S7</arm_group_label>
    <arm_group_label>S8</arm_group_label>
    <arm_group_label>S9</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Trial product 2</intervention_name>
    <description>Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL</description>
    <arm_group_label>S1</arm_group_label>
    <arm_group_label>S10</arm_group_label>
    <arm_group_label>S11</arm_group_label>
    <arm_group_label>S12</arm_group_label>
    <arm_group_label>S2</arm_group_label>
    <arm_group_label>S3</arm_group_label>
    <arm_group_label>S4</arm_group_label>
    <arm_group_label>S5</arm_group_label>
    <arm_group_label>S6</arm_group_label>
    <arm_group_label>S7</arm_group_label>
    <arm_group_label>S8</arm_group_label>
    <arm_group_label>S9</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Trial product 3</intervention_name>
    <description>Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL</description>
    <arm_group_label>S1</arm_group_label>
    <arm_group_label>S10</arm_group_label>
    <arm_group_label>S11</arm_group_label>
    <arm_group_label>S12</arm_group_label>
    <arm_group_label>S2</arm_group_label>
    <arm_group_label>S3</arm_group_label>
    <arm_group_label>S4</arm_group_label>
    <arm_group_label>S5</arm_group_label>
    <arm_group_label>S6</arm_group_label>
    <arm_group_label>S7</arm_group_label>
    <arm_group_label>S8</arm_group_label>
    <arm_group_label>S9</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Trial product 4</intervention_name>
    <description>Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL</description>
    <arm_group_label>S1</arm_group_label>
    <arm_group_label>S10</arm_group_label>
    <arm_group_label>S11</arm_group_label>
    <arm_group_label>S12</arm_group_label>
    <arm_group_label>S2</arm_group_label>
    <arm_group_label>S3</arm_group_label>
    <arm_group_label>S4</arm_group_label>
    <arm_group_label>S5</arm_group_label>
    <arm_group_label>S6</arm_group_label>
    <arm_group_label>S7</arm_group_label>
    <arm_group_label>S8</arm_group_label>
    <arm_group_label>S9</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Trial product 5</intervention_name>
    <description>Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL</description>
    <arm_group_label>S1</arm_group_label>
    <arm_group_label>S10</arm_group_label>
    <arm_group_label>S11</arm_group_label>
    <arm_group_label>S12</arm_group_label>
    <arm_group_label>S2</arm_group_label>
    <arm_group_label>S3</arm_group_label>
    <arm_group_label>S4</arm_group_label>
    <arm_group_label>S5</arm_group_label>
    <arm_group_label>S6</arm_group_label>
    <arm_group_label>S7</arm_group_label>
    <arm_group_label>S8</arm_group_label>
    <arm_group_label>S9</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Trial product 6</intervention_name>
    <description>Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL</description>
    <arm_group_label>S1</arm_group_label>
    <arm_group_label>S10</arm_group_label>
    <arm_group_label>S11</arm_group_label>
    <arm_group_label>S12</arm_group_label>
    <arm_group_label>S2</arm_group_label>
    <arm_group_label>S3</arm_group_label>
    <arm_group_label>S4</arm_group_label>
    <arm_group_label>S5</arm_group_label>
    <arm_group_label>S6</arm_group_label>
    <arm_group_label>S7</arm_group_label>
    <arm_group_label>S8</arm_group_label>
    <arm_group_label>S9</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Trial product 7</intervention_name>
    <description>Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL</description>
    <arm_group_label>S1</arm_group_label>
    <arm_group_label>S10</arm_group_label>
    <arm_group_label>S11</arm_group_label>
    <arm_group_label>S12</arm_group_label>
    <arm_group_label>S2</arm_group_label>
    <arm_group_label>S3</arm_group_label>
    <arm_group_label>S4</arm_group_label>
    <arm_group_label>S5</arm_group_label>
    <arm_group_label>S6</arm_group_label>
    <arm_group_label>S7</arm_group_label>
    <arm_group_label>S8</arm_group_label>
    <arm_group_label>S9</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Trial product 8</intervention_name>
    <description>Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL</description>
    <arm_group_label>S1</arm_group_label>
    <arm_group_label>S10</arm_group_label>
    <arm_group_label>S11</arm_group_label>
    <arm_group_label>S12</arm_group_label>
    <arm_group_label>S2</arm_group_label>
    <arm_group_label>S3</arm_group_label>
    <arm_group_label>S4</arm_group_label>
    <arm_group_label>S5</arm_group_label>
    <arm_group_label>S6</arm_group_label>
    <arm_group_label>S7</arm_group_label>
    <arm_group_label>S8</arm_group_label>
    <arm_group_label>S9</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Trial product 9</intervention_name>
    <description>Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL</description>
    <arm_group_label>S1</arm_group_label>
    <arm_group_label>S10</arm_group_label>
    <arm_group_label>S11</arm_group_label>
    <arm_group_label>S12</arm_group_label>
    <arm_group_label>S2</arm_group_label>
    <arm_group_label>S3</arm_group_label>
    <arm_group_label>S4</arm_group_label>
    <arm_group_label>S5</arm_group_label>
    <arm_group_label>S6</arm_group_label>
    <arm_group_label>S7</arm_group_label>
    <arm_group_label>S8</arm_group_label>
    <arm_group_label>S9</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Trial product 10</intervention_name>
    <description>Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL</description>
    <arm_group_label>S1</arm_group_label>
    <arm_group_label>S10</arm_group_label>
    <arm_group_label>S11</arm_group_label>
    <arm_group_label>S12</arm_group_label>
    <arm_group_label>S2</arm_group_label>
    <arm_group_label>S3</arm_group_label>
    <arm_group_label>S4</arm_group_label>
    <arm_group_label>S5</arm_group_label>
    <arm_group_label>S6</arm_group_label>
    <arm_group_label>S7</arm_group_label>
    <arm_group_label>S8</arm_group_label>
    <arm_group_label>S9</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Trial product 10</intervention_name>
    <description>Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL</description>
    <arm_group_label>S1</arm_group_label>
    <arm_group_label>S10</arm_group_label>
    <arm_group_label>S11</arm_group_label>
    <arm_group_label>S12</arm_group_label>
    <arm_group_label>S2</arm_group_label>
    <arm_group_label>S3</arm_group_label>
    <arm_group_label>S4</arm_group_label>
    <arm_group_label>S5</arm_group_label>
    <arm_group_label>S6</arm_group_label>
    <arm_group_label>S7</arm_group_label>
    <arm_group_label>S8</arm_group_label>
    <arm_group_label>S9</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Trial product 12</intervention_name>
    <description>Buffering agent: Glutamic acid 0.46 mg/mL, Disodium hydrogen phosphate, dihydrate 2.00 mg/mL Isotonic agent: Glycerol 15 mg/mL, NaCl 2.5 mg/mL</description>
    <arm_group_label>S1</arm_group_label>
    <arm_group_label>S10</arm_group_label>
    <arm_group_label>S11</arm_group_label>
    <arm_group_label>S12</arm_group_label>
    <arm_group_label>S2</arm_group_label>
    <arm_group_label>S3</arm_group_label>
    <arm_group_label>S4</arm_group_label>
    <arm_group_label>S5</arm_group_label>
    <arm_group_label>S6</arm_group_label>
    <arm_group_label>S7</arm_group_label>
    <arm_group_label>S8</arm_group_label>
    <arm_group_label>S9</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female, aged 18 to 69 years (both inclusive) at the time of signing informed&#xD;
             consent.&#xD;
&#xD;
          -  Body Mass Index (BMI) equal to or above 25.0 and below 30.0 kg/m^2.&#xD;
&#xD;
          -  Considered to be generally healthy based on the medical history, physical examination,&#xD;
             and the results of vital signs, electrocardiogram (ECG), and clinical laboratory tests&#xD;
             performed during the screening visit, as judged by the Investigator.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Female who is pregnant, breast-feeding or intends to become pregnant within 1 week of&#xD;
             Day 2 or is of childbearing potential and not using highly effective contraceptive&#xD;
             methods.&#xD;
&#xD;
          -  Any disorder which in the Investigator's opinion might jeopardise subject's safety,&#xD;
             evaluation of results, or compliance with the protocol.&#xD;
&#xD;
          -  Glycated haemoglobin (HbA1c) equal to or above 6.5 % (48 mmol/mol) at screening.&#xD;
&#xD;
          -  Use of prescription medicinal products or non-prescription drugs or herbal products,&#xD;
             except routine vitamins, topical medication (when not used in the abdominal area),&#xD;
             contraceptives or occasional use of paracetamol (not allowed within 24 hours prior to&#xD;
             Trial Product administration), within 14 days prior to Day 1.&#xD;
&#xD;
          -  Average intake of more than 21 units of alcohol per week for male subjects and more&#xD;
             than 14 units per week for female subjects: 1 unit of alcohol equals approximately 250&#xD;
             mL of beer, 100 mL of wine, or 35 mL of spirits.&#xD;
&#xD;
          -  Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines [including&#xD;
             ecstasy], cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants, and&#xD;
             alcohol) at screening and admission to the clinical research centre.&#xD;
&#xD;
          -  Use of tobacco and nicotine products, defined as any of the below:&#xD;
&#xD;
          -  Smoking more than 1 cigarette or the equivalent per day on average.&#xD;
&#xD;
          -  Not able or willing to refrain from smoking and use of nicotine substitute products&#xD;
             during the in-house period.&#xD;
&#xD;
          -  Subject is not able to understand and read English or Dutch, or subject is not able to&#xD;
             understand and comply with the trial requirements.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Reporting Anchor and Disclosur (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>Groningen</city>
        <zip>9728 NZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>October 18, 2021</last_update_submitted>
  <last_update_submitted_qc>October 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>According to the Novo Nordisk disclosure commitment on novonordisk-trials.com</ipd_description>
    <ipd_url>http://novonordisk-trials.com</ipd_url>
  </patient_data>
  <!-- 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/NCT04482725
org study id: NN9838-4703
secondary id: U1111-1250-7817
nct id: NCT04482725
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to investigate different solutions used to inject drugs under
      the skin. The solutions used in the study do not contain the drugs they will be used for, but
      they do contain excipients, which are inactive substances added to drug solutions to ensure
      the stability (shelf life and correct activity) of the drug product. The excipients are
      considered 'inactive substances' compared to the drug, but they may cause an undesirable
      effect at the injection site in the form of pain. However, their pain-causing potential has
      never been tested in a systematic way. The purpose of the study is to determine if there is a
      difference in the injection site pain experience after an injection under the skin
      (subcutaneous) with 12 different study products. These study products are excipient
      solutions, which are substances in medications next to the active substance. None of the 12
      products include active medication. This study will be performed in 108 healthy male and
      female volunteers.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Intensity of injection site pain
time frame: 1 min after each injection (Day 1 and Day 2)
description: mm on a 100 mm horizontal visual-analogue scale (where 0 mm
= no pain, 100 mm = unbearable pain)
arm group label: S1
arm group type: Experimental
description: Day 1: Trial products 1-2-12-3-11-4 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.
Day 2: Trial products 10-5-9-6-8-7 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.
arm group label: S2
arm group type: Experimental
description: Day 1: Trial products 2-3-1-4-12-5 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.
Day 2: Trial products 11-6-10-7-9-8 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.
arm group label: S3
arm group type: Experimental
description: Day 1: Trial products 3-4-2-5-1-6 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.
Day 2: Trial products 12-7-11-8-10-9 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.
arm group label: S4
arm group type: Experimental
description: Day 1: Trial products 4-5-3-6-2-7 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.
Day 2: Trial products 1-8-12-9-11-10 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.
arm group label: S5
arm group type: Experimental
description: Day 1: Trial products 5-6-4-7-3-8 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.
Day 2: Trial products 2-9-1-10-12-11 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.
arm group label: S6
arm group type: Experimental
description: Day 1: Trial products 6-7-5-8-4-9 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.
Day 2: Trial products 3-10-2-11-1-12 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.
arm group label: S7
arm group type: Experimental
description: Day 1: Trial products 7-8-6-9-5-10 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.
Day 2: Trial products 4-11-3-12-2-1-given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.
arm group label: S8
arm group type: Experimental
description: Day 1: Trial products 8-9-7-10-6-11 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.
Day 2: Trial products 5-12-4-1-3-2 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.
arm group label: S9
arm group type: Experimental
description: Day 1: Trial products 9-10-8-11-7-12 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.
Day 2: Trial products 6-1-5-2-4-3 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.
arm group label: S10
arm group type: Experimental
description: Day 1: Trial products 10-11-9-12-8-1 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.
Day 2: Trial products 7-2-6-3-5-4 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.
arm group label: S11
arm group type: Experimental
description: Day 1: Trial products 11-12-10-1-9-2 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.
Day 2: Trial products 8-3-7-4-6-5 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.
arm group label: S12
arm group type: Experimental
description: Day 1: Trial products 12-1-11-2-10-3 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.
Day 2: Trial products 9-4-8-5-7-6 given as subcutaneous injections (s.c., under the skin) on alternate sides of the abdomen.
intervention type: Other
intervention name: Trial product 1
description: Buffering agent: N/A Isotonic agent: NaCl 9.0 mg/mL
arm group label: S1
arm group label: S10
arm group label: S11
arm group label: S12
arm group label: S2
arm group label: S3
arm group label: S4
arm group label: S5
arm group label: S6
arm group label: S7
arm group label: S8
arm group label: S9
intervention type: Other
intervention name: Trial product 2
description: Buffering agent: Disodium hydrogen phosphate, dihydrate 1.42 mg/mL Isotonic agent: NaCl 8.25 mg/mL
arm group label: S1
arm group label: S10
arm group label: S11
arm group label: S12
arm group label: S2
arm group label: S3
arm group label: S4
arm group label: S5
arm group label: S6
arm group label: S7
arm group label: S8
arm group label: S9
intervention type: Other
intervention name: Trial product 3
description: Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Propylene glycol 18.5 mg/mL
arm group label: S1
arm group label: S10
arm group label: S11
arm group label: S12
arm group label: S2
arm group label: S3
arm group label: S4
arm group label: S5
arm group label: S6
arm group label: S7
arm group label: S8
arm group label: S9
intervention type: Other
intervention name: Trial product 4
description: Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Glycerol 22.0 mg/mL
arm group label: S1
arm group label: S10
arm group label: S11
arm group label: S12
arm group label: S2
arm group label: S3
arm group label: S4
arm group label: S5
arm group label: S6
arm group label: S7
arm group label: S8
arm group label: S9
intervention type: Other
intervention name: Trial product 5
description: Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Mannitol 44.0 mg/mL
arm group label: S1
arm group label: S10
arm group label: S11
arm group label: S12
arm group label: S2
arm group label: S3
arm group label: S4
arm group label: S5
arm group label: S6
arm group label: S7
arm group label: S8
arm group label: S9
intervention type: Other
intervention name: Trial product 6
description: Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: Sucrose 82.0 mg/mL
arm group label: S1
arm group label: S10
arm group label: S11
arm group label: S12
arm group label: S2
arm group label: S3
arm group label: S4
arm group label: S5
arm group label: S6
arm group label: S7
arm group label: S8
arm group label: S9
intervention type: Other
intervention name: Trial product 7
description: Buffering agent: Disodium hydrogen phosphate dihydrate 1.42 mg/mL Isotonic agent: a,a-Trehalose, dihydrate 90.0 mg/mL
arm group label: S1
arm group label: S10
arm group label: S11
arm group label: S12
arm group label: S2
arm group label: S3
arm group label: S4
arm group label: S5
arm group label: S6
arm group label: S7
arm group label: S8
arm group label: S9
intervention type: Other
intervention name: Trial product 8
description: Buffering agent: Disodium hydrogen phosphate dihydrate 5.34 mg/mL Isotonic agent: NaCl 6.72 mg/mL
arm group label: S1
arm group label: S10
arm group label: S11
arm group label: S12
arm group label: S2
arm group label: S3
arm group label: S4
arm group label: S5
arm group label: S6
arm group label: S7
arm group label: S8
arm group label: S9
intervention type: Other
intervention name: Trial product 9
description: Buffering agent: Tris 2.4 mg/mL Isotonic agent: Propylene glycol 19 mg/mL
arm group label: S1
arm group label: S10
arm group label: S11
arm group label: S12
arm group label: S2
arm group label: S3
arm group label: S4
arm group label: S5
arm group label: S6
arm group label: S7
arm group label: S8
arm group label: S9
intervention type: Other
intervention name: Trial product 10
description: Buffering agent: Glutamic acid 0.74 mg/mL Isotonic agent: Glycerol 24.0 mg/mL
arm group label: S1
arm group label: S10
arm group label: S11
arm group label: S12
arm group label: S2
arm group label: S3
arm group label: S4
arm group label: S5
arm group label: S6
arm group label: S7
arm group label: S8
arm group label: S9
intervention type: Other
intervention name: Trial product 10
description: Buffering agent: Sodium Acetate, trihydrate 0.68 mg/mL Isotonic agent: Glycerol 24.0 mg/mL
arm group label: S1
arm group label: S10
arm group label: S11
arm group label: S12
arm group label: S2
arm group label: S3
arm group label: S4
arm group label: S5
arm group label: S6
arm group label: S7
arm group label: S8
arm group label: S9
intervention type: Other
intervention name: Trial product 12
description: Buffering agent: Glutamic acid 0.46 mg/mL, Disodium hydrogen phosphate, dihydrate 2.00 mg/mL Isotonic agent: Glycerol 15 mg/mL, NaCl 2.5 mg/mL
arm group label: S1
arm group label: S10
arm group label: S11
arm group label: S12
arm group label: S2
arm group label: S3
arm group label: S4
arm group label: S5
arm group label: S6
arm group label: S7
arm group label: S8
arm group label: S9
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Clinical Reporting Anchor and Disclosur (1452)
role: Study Director
affiliation: Novo Nordisk A/S
facility: 
country: Netherlands
responsible party type: Sponsor
sharing ipd: Yes
ipd description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
ipd url: http://novonordisk-trials.com