<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/NCT02212067</url>
  </required_header>
  <id_info>
    <org_study_id>NN9535-3635</org_study_id>
    <secondary_id>2013-002173-22</secondary_id>
    <secondary_id>U1111-1143-1206</secondary_id>
    <nct_id>NCT02212067</nct_id>
  </id_info>
  <brief_title>A Trial Investigating the Effects of Semaglutide on ß-cell Function in Subjects With Type 2 Diabetes</brief_title>
  <official_title>A Single-centre, Randomised, Double-blind, Multiple-dose, Placebo-controlled, Parallel-group Trial Investigating the Effects of Semaglutide on ß-cell Function 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial is conducted in Europe. The aim of the trial is to investigate the effects of&#xD;
      semaglutide on ß-cell function in subjects with type 2 diabetes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 11, 2014</start_date>
  <completion_date type="Actual">May 11, 2015</completion_date>
  <primary_completion_date type="Actual">May 11, 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>Area under the serum insulin concentration time curve from 0 to 10 minutes after a 25 g glucose bolus i.v. infusion (IVGTT,intravenous glucose tolerance test) over 2 minutes</measure>
    <time_frame>Day -1, day 86</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the serum insulin concentration time curve from 10-120 minutes after a 25 g glucose bolus i.v. infusion (IVGTT).</measure>
    <time_frame>Day -1, day 86</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area under the insulin secretion rate (ISR)-time curve within 0 to 10 min after i.v. glucose challenge</measure>
    <time_frame>Day -1, day 86</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the ISR-time curve within 10 to 120 min after i.v. glucose challenge</measure>
    <time_frame>Day -1, day 86</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>24-hour plasma glucose, glucagon, serum insulin, and C-peptide measured as total AUC0-24h during a test day with 3 standardised meals</measure>
    <time_frame>Day -1, day 85</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the insulin secretion rate (ISR)-time curve within 0 to 10 min after i.v. arginine application; ISR will be derived from the C-peptide concentration profile</measure>
    <time_frame>Day -1, day 86</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the ISR curve over the 5-12 mmol/L (90-216 mg/dL) glucose interval; ISR will be derived from the C-peptide concentration profile</measure>
    <time_frame>Day -1, day 87</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Slope of the ISR vs. glucose curve (dose-response relationship)</measure>
    <time_frame>Day -1, day 87</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">87</enrollment>
  <condition>Diabetes</condition>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Semaglutide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Total of 12 visits</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Total of 12 visits</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy subjects</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Total of 2 visits</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>semaglutide</intervention_name>
    <description>Administered subcutaneously (s.c., under the skin) once weekly for 12 weeks.</description>
    <arm_group_label>Semaglutide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>Administered subcutaneously (s.c., under the skin) once weekly for 12 weeks.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 18-64 years (both inclusive) at the time of signing the informed consent&#xD;
&#xD;
          -  For subjects with type 2 diabetes:&#xD;
&#xD;
          -  Male and female subjects diagnosed with type 2 diabetes&#xD;
&#xD;
          -  Treated with diet and exercise and/or metformin monotherapy. Metformin dose should be&#xD;
             unchanged in a period of 30 days prior to screening&#xD;
&#xD;
          -  Body Mass Index (BMI) between 20.0-35.0 kg/m^2 (both inclusive)&#xD;
&#xD;
          -  Glycosylated haemoglobin (HbA1c) between 6.5-9.0 % (both inclusive)&#xD;
&#xD;
          -  For healthy control group for graded glucose infusion:&#xD;
&#xD;
          -  Healthy male and female subjects&#xD;
&#xD;
          -  BMI between 24.0-32.0 kg/m^2 (both inclusive)&#xD;
&#xD;
          -  HbA1c less than 6.5 %&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Female who is pregnant, breast-feeding or intends to become pregnant or is of child&#xD;
             bearing potential and not using an adequate contraceptive method. Women of child&#xD;
             bearing potential must use an effective method of birth control for the duration of&#xD;
             the trial and for subjects with type 2 diabetes for 5 weeks following the last dose of&#xD;
             semaglutide. Only highly effective methods of birth control are accepted (i.e. one&#xD;
             that results in less than 1% per year failure rate when used consistently and&#xD;
             correctly such as implants, injectables, combined oral contraceptives, some&#xD;
             intrauterine devices), or sexual abstinence or vasectomised partner&#xD;
&#xD;
          -  Any clinically significant disease history, in the opinion of the investigator, or&#xD;
             systemic or organ disease including: cardiac, pulmonary, gastrointestinal, hepatic,&#xD;
             neurologic, renal, genitourinary and endocrine, dermatologic or hematologic&#xD;
&#xD;
          -  Use of any prescription or non-prescription medication which could interfere with&#xD;
             trial pharmacokinetic or pharmacodynamic results, as judged by the investigator or&#xD;
             specifically: a) current treatment with systemic (oral or i.v.) corticosteroids,&#xD;
             non-selective betablockers, b) thyroid hormones are not allowed unless the use of&#xD;
             these have been stable during the past 2 month prior to screening&#xD;
&#xD;
          -  History of drug/chemical substance abuse within 1 year prior to screening, or a&#xD;
             positive result in the urine drug test&#xD;
&#xD;
          -  History of alcohol abuse within 1 year prior to screening, or a positive result in the&#xD;
             alcohol breath test&#xD;
&#xD;
          -  Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent&#xD;
             per day)&#xD;
&#xD;
          -  Not able or willing to refrain from smoking and use of nicotine gum or transdermal&#xD;
             nicotine patches during the inpatient period&#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>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>
  <results_reference>
    <citation>Kapitza C, Dahl K, Jacobsen JB, Axelsen MB, Flint A. Effects of semaglutide on beta cell function and glycaemic control in participants with type 2 diabetes: a randomised, double-blind, placebo-controlled trial. Diabetologia. 2017 Aug;60(8):1390-1399. doi: 10.1007/s00125-017-4289-0. Epub 2017 May 19.</citation>
    <PMID>28526920</PMID>
  </results_reference>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2014</study_first_posted>
  <last_update_submitted>March 6, 2018</last_update_submitted>
  <last_update_submitted_qc>March 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2018</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>
  <!-- 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/NCT02212067
org study id: NN9535-3635
secondary id: 2013-002173-22
secondary id: U1111-1143-1206
nct id: NCT02212067
lead sponsor: 
has dmc: No
This trial is conducted in Europe. The aim of the trial is to investigate the effects of
      semaglutide on ß-cell function in subjects with type 2 diabetes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Area under the serum insulin concentration time curve from 0 to 10 minutes after a 25 g glucose bolus i.v. infusion (IVGTT,intravenous glucose tolerance test) over 2 minutes
time frame: Day -1, day 86
measure: Area under the serum insulin concentration time curve from 10-120 minutes after a 25 g glucose bolus i.v. infusion (IVGTT).
time frame: Day -1, day 86
measure: Area under the insulin secretion rate (ISR)-time curve within 0 to 10 min after i.v. glucose challenge
time frame: Day -1, day 86
measure: Area under the ISR-time curve within 10 to 120 min after i.v. glucose challenge
time frame: Day -1, day 86
measure: 24-hour plasma glucose, glucagon, serum insulin, and C-peptide measured as total AUC0-24h during a test day with 3 standardised meals
time frame: Day -1, day 85
measure: Area under the insulin secretion rate (ISR)-time curve within 0 to 10 min after i.v. arginine application; ISR will be derived from the C-peptide concentration profile
time frame: Day -1, day 86
measure: Area under the ISR curve over the 5-12 mmol/L (90-216 mg/dL) glucose interval; ISR will be derived from the C-peptide concentration profile
time frame: Day -1, day 87
measure: Slope of the ISR vs. glucose curve (dose-response relationship)
time frame: Day -1, day 87
arm group label: Semaglutide
arm group type: Experimental
description: Total of 12 visits
arm group label: Placebo
arm group type: Placebo Comparator
description: Total of 12 visits
arm group label: Healthy subjects
arm group type: No Intervention
description: Total of 2 visits
intervention type: Drug
intervention name: semaglutide
description: Administered subcutaneously (s.c., under the skin) once weekly for 12 weeks.
arm group label: Semaglutide
intervention type: Drug
intervention name: placebo
description: Administered subcutaneously (s.c., under the skin) once weekly for 12 weeks.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: No
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
citation: Kapitza C, Dahl K, Jacobsen JB, Axelsen MB, Flint A. Effects of semaglutide on beta cell function and glycaemic control in participants with type 2 diabetes: a randomised, double-blind, placebo-controlled trial. Diabetologia. 2017 Aug;60(8):1390-1399. doi: 10.1007/s00125-017-4289-0. Epub 2017 May 19.
PMID: 28526920
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2