<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/NCT03789578</url>
  </required_header>
  <id_info>
    <org_study_id>NN1535-4359</org_study_id>
    <secondary_id>U1111-1204-8233</secondary_id>
    <secondary_id>2017-004538-27</secondary_id>
    <nct_id>NCT03789578</nct_id>
  </id_info>
  <brief_title>A Research Study to Look at How Insulin 287 and Semaglutide Work in the Body of People With Type 2 Diabetes When Taken Alone or Together</brief_title>
  <official_title>A Trial to Investigate Single Dose Pharmacokinetics of NNC0148-0287sema in a Fixed Ratio Compared With Insulin 287 and Semaglutide Given Separately in Subjects With Type 2 Diabetes</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 study will look at how insulin 287 and semaglutide work in the body, both when given&#xD;
      alone or together. This study will look at the way insulin 287 and semaglutide reach and stay&#xD;
      in participants' blood after injection when given alone or together. Participants will get 3&#xD;
      study medicines at 3 different time points: 1) a combination of semaglutide plus insulin 287,&#xD;
      2) insulin 287 alone and 3) semaglutide alone. The order in which participants get them is&#xD;
      decided by chance. Participants will get all medicines as an injection under the skin in the&#xD;
      thigh. The injections will be done by study staff. The time between injections is 6 to 9&#xD;
      weeks. The study will last for about 19 to 32 weeks in total.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 17, 2019</start_date>
  <completion_date type="Actual">October 10, 2019</completion_date>
  <primary_completion_date type="Actual">October 10, 2019</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>Crossover Assignment</intervention_model>
    <intervention_model_description>This is a three-period cross-over trial. The treatments to be used are: Treatment A: insulin 287, Treatment B: semaglutide, and Treatment C: NNC0148-0287sema. The subjects will be randomised to one of the six treatment sequences in the trial: 1) ABC, 2) ACB, 3) BAC, 4) BCA, 5) CAB, and 6) CBA. The trial includes a screening visit followed by three 5 -week periods with pharmacokinetic sampling after single dose administration. The dose periods are separated by a 1-4 week washout period (from last pharmacokinetic sampling to next dosing). The follow-up period is 1-4 weeks after last pharmacokinetic sampling in period 3 (i.e. 6 to 9 weeks after last trial product administration). The total trial duration for the individual subjects participating in the trial will be 19 to 32 weeks (including follow-up), depending on individual visit schedules.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Sponsor staff involved in the clinical trial is masked according to company standard procedures.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>AUCI287, 0-tz, area under the serum insulin 287 concentration-time curve from 0 hours to last quantifiable observation after a single dose</measure>
    <time_frame>0-840 hours</time_frame>
    <description>Measured in pmol*h/L for insulin 287 following administration of a fixed ratio of NNC0148-0287sema and insulin 287.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUCSema,0-tz, area under the plasma semaglutide concentration-time curve from 0 hours to last quantifiable observation after a single dose</measure>
    <time_frame>0-840 hours</time_frame>
    <description>Measured in pmol*h/L for semaglutide following administration of a fixed ratio of NNC0148-0287sema and semaglutide.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>AUCI287,0-∞ area under the serum insulin 287 concentration-time curve from 0 hours to infinity after a single dose</measure>
    <time_frame>0-840 hours</time_frame>
    <description>Measured in pmol*h/L for insulin 287 following administration of a fixed ratio of NNC0148-0287sema and insulin 287.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax, I287, maximum observed serum insulin 287 concentration after a single dose</measure>
    <time_frame>0-840 hours</time_frame>
    <description>Measured in pmol/L for insulin 287 following administration of a fixed ratio of NNC0148-0287sema and insulin 287.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tmax, I287, time to maximum observed serum insulin 287 concentration after a single dose</measure>
    <time_frame>0-840 hours</time_frame>
    <description>Measured in hour (h) for insulin 287 following administration of a fixed ratio of NNC0148-0287sema and insulin 287.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUCSema,0-∞, area under the plasma semaglutide concentration-time curve from 0 hours to infinity after a single dose</measure>
    <time_frame>0-840 hours</time_frame>
    <description>Measured in pmol*h/L for semaglutide following administration of a fixed ratio of NNC0148-0287sema and semaglutide.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax,Sema, maximum observed plasma semaglutide concentration after a single dose</measure>
    <time_frame>0-840 hours</time_frame>
    <description>Measured in pmol/L for semaglutide following administration of a fixed ratio of NNC0148-0287sema and semaglutide.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tmax,Sema, time to maximum observed plasma semaglutide concentration after a single dose</measure>
    <time_frame>0-840 hours</time_frame>
    <description>Measured in hour (h) for semaglutide following administration of a fixed ratio of NNC0148-0287sema and semaglutide.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of treatment emergent adverse events</measure>
    <time_frame>Day 1 (beginning of each period) to day 36 (end of each period)</time_frame>
    <description>Count of events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of hypoglycaemic episodes</measure>
    <time_frame>Day 1 (beginning of each period) to day 36 (end of each period)</time_frame>
    <description>Count of episodes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antibodies for insulin 287: Change in anti-insulin 287 binding antibody levels</measure>
    <time_frame>Day -1 (pre-dose), Day 36 (end of period)</time_frame>
    <description>Measured as percentage B/T following administration of NNC0148 -0287sema and insulin 287.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antibodies for insulin 287: Occurrence of anti-insulin 287 binding antibodies</measure>
    <time_frame>Day 36 (end of period)</time_frame>
    <description>Percentage of events (yes/no) following administration of NNC0148 -0287sema and insulin 287.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antibodies for insulin 287: Occurrence of anti-insulin 287 binding antibodies cross reacting to human insulin</measure>
    <time_frame>Day 36 (end of period)</time_frame>
    <description>Percentage of events (yes/no) following administration of NNC0148 -0287sema and insulin 287.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antibodies for semaglutide: Change in anti-semaglutide binding antibody levels</measure>
    <time_frame>Day -1 (pre-dose), Day 36 (end of period)</time_frame>
    <description>Measured as percentage B/T following administration of NNC0148 -0287sema</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antibodies for semaglutide: Occurrence of anti-semaglutide binding antibodies</measure>
    <time_frame>Day 36 (end of period)</time_frame>
    <description>Percentage of events (yes/no) following administration of NNC0148 -0287sema.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antibodies for semaglutide: Occurrence of anti-semaglutide binding antibodies cross reacting to endogenous glucagon-like peptide-1 (GLP-1)</measure>
    <time_frame>Day 36 (end of period)</time_frame>
    <description>Percentage of events (yes/no) following administration of NNC0148 -0287sema.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Binding antibodies and in vitro neutralising antibodies (semaglutide only): Anti-semaglutide binding antibody levels</measure>
    <time_frame>Day 151 (follow-up/end-of-trial visit)</time_frame>
    <description>Measured as percentage B/T.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Binding antibodies and in vitro neutralising antibodies (semaglutide only): Occurrence of anti-semaglutide binding antibodies cross reacting to endogenous GLP-1</measure>
    <time_frame>Day 151 (follow-up/end-of-trial visit)</time_frame>
    <description>Percentage of events (yes/no).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Binding antibodies and in vitro neutralising antibodies (semaglutide only): Anti-insulin 287 binding antibody levels</measure>
    <time_frame>Day 151 (follow-up/end-of-trial visit)</time_frame>
    <description>Measured as percentage B/T.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Binding antibodies and in vitro neutralising antibodies (semaglutide only): Occurrence of anti-insulin 287 binding antibodies cross reacting to human insulin</measure>
    <time_frame>Day 151 (follow-up/end-of-trial visit)</time_frame>
    <description>Percentage of events (yes/no).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Binding antibodies and in vitro neutralising antibodies (semaglutide only): Occurrence of anti-semaglutide neutralising antibodies</measure>
    <time_frame>Day 151 (follow-up/end-of-trial visit)</time_frame>
    <description>Percentage of events (yes/no).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Binding antibodies and in vitro neutralising antibodies (semaglutide only): Occurrence of anti-semaglutide neutralising antibodies cross reacting with endogenous GLP-1</measure>
    <time_frame>Day 151 (follow-up/end-of-trial visit)</time_frame>
    <description>Percentage of events (yes/no).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Semaglutide plus insulin 287</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will get a single dose of fixed-ratio combination of insulin 287 and semaglutide (NNC0148-0287sema (treatment C)).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Semaglutide alone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will get a single dose of semaglutide (treatment B) alone.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Insulin 287 alone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will get a single dose of insulin 287 (NNC0148-0287 (treatment A)) alone.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NNC0148-0287sema</intervention_name>
    <description>Study staff will inject NNC0148-0287sema, 175unit (U)/0.5 mg in the morning after fasting under the skin of participants' thigh using a needle and a pen.</description>
    <arm_group_label>Semaglutide plus insulin 287</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Semaglutide</intervention_name>
    <description>Study staff will inject semaglutide, 0.5 mg alone in the morning after fasting under the skin of participants' thigh using a needle and a pen.</description>
    <arm_group_label>Semaglutide alone</arm_group_label>
    <other_name>Ozempic®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NNC0148-0287</intervention_name>
    <description>Study staff will inject insulin 287 (NNC0148-0287), 175U alone in the morning after fasting under the skin of participants' thigh using a needle and a pen.</description>
    <arm_group_label>Insulin 287 alone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female, aged 18-64 years (both inclusive) at the time of signing informed&#xD;
             consent&#xD;
&#xD;
          -  Diagnosed with type 2 diabetes mellitus more than or equal to 180 days prior to the&#xD;
             day of screening&#xD;
&#xD;
          -  Body weight between 80.0 to 120.0 kg (both inclusive)&#xD;
&#xD;
          -  Glycosylated haemoglobin (HbA1c) 6.0 to 8.5% (both inclusive)&#xD;
&#xD;
          -  No current and no regular previous intake of insulin. Previous insulin treatment for&#xD;
             short periods of time (a maximum of 14 days) is allowed, as well as insulin use during&#xD;
             a previous period of gestational diabetes in the past (as declared by the subject or&#xD;
             reported in the medical records)&#xD;
&#xD;
          -  Stable daily dose(s) of the following anti-diabetic drug(s)/regimen within the past 90&#xD;
             days prior to the day of screening: a) Any metformin formulation (dose as documented&#xD;
             in the subject medical record), b) One other oral antidiabetic drug (dose as&#xD;
             documented in the subject medical record) is allowed, but not mandatory: Insulin&#xD;
             secretagogue (sulphonylureas), dipeptidyl peptidase 4 (DPP-4) inhibitor and sodium&#xD;
             glucose co-transporter 2 (SGLT2) inhibitor&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known or suspected hypersensitivity to trial products or related products&#xD;
&#xD;
          -  Female who is pregnant, breast-feeding or intends to become pregnant or is of&#xD;
             child-bearing potential and not using adequate contraceptive methods&#xD;
&#xD;
          -  Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event within the past&#xD;
             180 days) or hypoglycaemic unawareness as judged by the investigator or&#xD;
             hospitalisation for diabetic ketoacidosis within the past 180 days prior to the day of&#xD;
             screening&#xD;
&#xD;
          -  Receipt of any investigational medicinal product within 90 days before screening&#xD;
&#xD;
          -  History of severe allergies to drugs or foods or a history of severe anaphylactic&#xD;
             reaction&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Reporting Anchor and Disclosure (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>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>December 27, 2018</study_first_submitted>
  <study_first_submitted_qc>December 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 28, 2018</study_first_posted>
  <last_update_submitted>September 28, 2021</last_update_submitted>
  <last_update_submitted_qc>September 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2021</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>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>According to the Novo Nordisk disclosure commitment on novonordisk-trials.com</ipd_description>
    <ipd_url>https://www.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/NCT03789578
org study id: NN1535-4359
secondary id: U1111-1204-8233
secondary id: 2017-004538-27
nct id: NCT03789578
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study will look at how insulin 287 and semaglutide work in the body, both when given
      alone or together. This study will look at the way insulin 287 and semaglutide reach and stay
      in participants' blood after injection when given alone or together. Participants will get 3
      study medicines at 3 different time points: 1) a combination of semaglutide plus insulin 287,
      2) insulin 287 alone and 3) semaglutide alone. The order in which participants get them is
      decided by chance. Participants will get all medicines as an injection under the skin in the
      thigh. The injections will be done by study staff. The time between injections is 6 to 9
      weeks. The study will last for about 19 to 32 weeks in total.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: This is a three-period cross-over trial. The treatments to be used are: Treatment A: insulin 287, Treatment B: semaglutide, and Treatment C: NNC0148-0287sema. The subjects will be randomised to one of the six treatment sequences in the trial: 1) ABC, 2) ACB, 3) BAC, 4) BCA, 5) CAB, and 6) CBA. The trial includes a screening visit followed by three 5 -week periods with pharmacokinetic sampling after single dose administration. The dose periods are separated by a 1-4 week washout period (from last pharmacokinetic sampling to next dosing). The follow-up period is 1-4 weeks after last pharmacokinetic sampling in period 3 (i.e. 6 to 9 weeks after last trial product administration). The total trial duration for the individual subjects participating in the trial will be 19 to 32 weeks (including follow-up), depending on individual visit schedules.
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
measure: AUCI287, 0-tz, area under the serum insulin 287 concentration-time curve from 0 hours to last quantifiable observation after a single dose
time frame: 0-840 hours
description: Measured in pmol*h/L for insulin 287 following administration of a fixed ratio of NNC0148-0287sema and insulin 287.
measure: AUCSema,0-tz, area under the plasma semaglutide concentration-time curve from 0 hours to last quantifiable observation after a single dose
time frame: 0-840 hours
description: Measured in pmol*h/L for semaglutide following administration of a fixed ratio of NNC0148-0287sema and semaglutide.
measure: AUCI287,0-∞ area under the serum insulin 287 concentration-time curve from 0 hours to infinity after a single dose
time frame: 0-840 hours
description: Measured in pmol*h/L for insulin 287 following administration of a fixed ratio of NNC0148-0287sema and insulin 287.
measure: Cmax, I287, maximum observed serum insulin 287 concentration after a single dose
time frame: 0-840 hours
description: Measured in pmol/L for insulin 287 following administration of a fixed ratio of NNC0148-0287sema and insulin 287.
measure: tmax, I287, time to maximum observed serum insulin 287 concentration after a single dose
time frame: 0-840 hours
description: Measured in hour (h) for insulin 287 following administration of a fixed ratio of NNC0148-0287sema and insulin 287.
measure: AUCSema,0-∞, area under the plasma semaglutide concentration-time curve from 0 hours to infinity after a single dose
time frame: 0-840 hours
description: Measured in pmol*h/L for semaglutide following administration of a fixed ratio of NNC0148-0287sema and semaglutide.
measure: Cmax,Sema, maximum observed plasma semaglutide concentration after a single dose
time frame: 0-840 hours
description: Measured in pmol/L for semaglutide following administration of a fixed ratio of NNC0148-0287sema and semaglutide.
measure: tmax,Sema, time to maximum observed plasma semaglutide concentration after a single dose
time frame: 0-840 hours
description: Measured in hour (h) for semaglutide following administration of a fixed ratio of NNC0148-0287sema and semaglutide.
measure: Number of treatment emergent adverse events
time frame: Day 1 (beginning of each period) to day 36 (end of each period)
description: Count of events.
measure: Number of hypoglycaemic episodes
time frame: Day 1 (beginning of each period) to day 36 (end of each period)
description: Count of episodes.
measure: Antibodies for insulin 287: Change in anti-insulin 287 binding antibody levels
time frame: Day -1 (pre-dose), Day 36 (end of period)
description: Measured as percentage B/T following administration of NNC0148 -0287sema and insulin 287.
measure: Antibodies for insulin 287: Occurrence of anti-insulin 287 binding antibodies
time frame: Day 36 (end of period)
description: Percentage of events (yes/no) following administration of NNC0148 -0287sema and insulin 287.
measure: Antibodies for insulin 287: Occurrence of anti-insulin 287 binding antibodies cross reacting to human insulin
time frame: Day 36 (end of period)
description: Percentage of events (yes/no) following administration of NNC0148 -0287sema and insulin 287.
measure: Antibodies for semaglutide: Change in anti-semaglutide binding antibody levels
time frame: Day -1 (pre-dose), Day 36 (end of period)
description: Measured as percentage B/T following administration of NNC0148 -0287sema
measure: Antibodies for semaglutide: Occurrence of anti-semaglutide binding antibodies
time frame: Day 36 (end of period)
description: Percentage of events (yes/no) following administration of NNC0148 -0287sema.
measure: Antibodies for semaglutide: Occurrence of anti-semaglutide binding antibodies cross reacting to endogenous glucagon-like peptide-1 (GLP-1)
time frame: Day 36 (end of period)
description: Percentage of events (yes/no) following administration of NNC0148 -0287sema.
measure: Binding antibodies and in vitro neutralising antibodies (semaglutide only): Anti-semaglutide binding antibody levels
time frame: Day 151 (follow-up/end-of-trial visit)
description: Measured as percentage B/T.
measure: Binding antibodies and in vitro neutralising antibodies (semaglutide only): Occurrence of anti-semaglutide binding antibodies cross reacting to endogenous GLP-1
time frame: Day 151 (follow-up/end-of-trial visit)
description: Percentage of events (yes/no).
measure: Binding antibodies and in vitro neutralising antibodies (semaglutide only): Anti-insulin 287 binding antibody levels
time frame: Day 151 (follow-up/end-of-trial visit)
description: Measured as percentage B/T.
measure: Binding antibodies and in vitro neutralising antibodies (semaglutide only): Occurrence of anti-insulin 287 binding antibodies cross reacting to human insulin
time frame: Day 151 (follow-up/end-of-trial visit)
description: Percentage of events (yes/no).
measure: Binding antibodies and in vitro neutralising antibodies (semaglutide only): Occurrence of anti-semaglutide neutralising antibodies
time frame: Day 151 (follow-up/end-of-trial visit)
description: Percentage of events (yes/no).
measure: Binding antibodies and in vitro neutralising antibodies (semaglutide only): Occurrence of anti-semaglutide neutralising antibodies cross reacting with endogenous GLP-1
time frame: Day 151 (follow-up/end-of-trial visit)
description: Percentage of events (yes/no).
arm group label: Semaglutide plus insulin 287
arm group type: Experimental
description: Participants will get a single dose of fixed-ratio combination of insulin 287 and semaglutide (NNC0148-0287sema (treatment C)).
arm group label: Semaglutide alone
arm group type: Experimental
description: Participants will get a single dose of semaglutide (treatment B) alone.
arm group label: Insulin 287 alone
arm group type: Experimental
description: Participants will get a single dose of insulin 287 (NNC0148-0287 (treatment A)) alone.
intervention type: Drug
intervention name: NNC0148-0287sema
description: Study staff will inject NNC0148-0287sema, 175unit (U)/0.5 mg in the morning after fasting under the skin of participants' thigh using a needle and a pen.
arm group label: Semaglutide plus insulin 287
intervention type: Drug
intervention name: Semaglutide
description: Study staff will inject semaglutide, 0.5 mg alone in the morning after fasting under the skin of participants' thigh using a needle and a pen.
arm group label: Semaglutide alone
other name: Ozempic®
intervention type: Drug
intervention name: NNC0148-0287
description: Study staff will inject insulin 287 (NNC0148-0287), 175U alone in the morning after fasting under the skin of participants' thigh using a needle and a pen.
arm group label: Insulin 287 alone
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: No
last name: Clinical Reporting Anchor and Disclosure (1452)
role: Study Director
affiliation: Novo Nordisk A/S
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: Yes
ipd description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
ipd url: https://www.novonordisk-trials.com