<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/NCT01686945</url>
  </required_header>
  <id_info>
    <org_study_id>NN9924-3991</org_study_id>
    <secondary_id>2012-000361-20</secondary_id>
    <secondary_id>U1111-1127-4408</secondary_id>
    <nct_id>NCT01686945</nct_id>
  </id_info>
  <brief_title>Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of a Long-acting GLP-1 Analogue in Healthy Male Subjects and Male Subjects With Type 2 Diabetes</brief_title>
  <official_title>Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of a Long-acting GLP-1 Analogue in Healthy Male Subjects and Male 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 safety,&#xD;
      tolerability, pharmacokinetics (the exposure of the trial drug in the body), and&#xD;
      pharmacodynamics (the effect of the investigated drug on the body) of multiple doses of a&#xD;
      long-acting GLP-1 analogue (oral semaglutide) and a carrier in healthy male subjects and male&#xD;
      subjects with type 2 diabetes (T2D).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 19, 2012</start_date>
  <completion_date type="Actual">April 8, 2013</completion_date>
  <primary_completion_date type="Actual">April 8, 2013</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>Number of treatment emergent adverse events (TEAEs) recorded</measure>
    <time_frame>From the time of first dosing and until completion of the post treatment follow-up visits (Day 90 to 104)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration curve over the dosing interval (0-24 hours)</measure>
    <time_frame>After the last 3 daily doses for semaglutide and carrier</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in fasting plasma glucose (FPG)</measure>
    <time_frame>Week 0, week 10 (Day 69)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in C-peptide</measure>
    <time_frame>Week 0, week 10 (Day 69)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in insulin</measure>
    <time_frame>Week 0, week 10 (Day 69)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in glucagon</measure>
    <time_frame>Week 0, week 10 (Day 69)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in glycosylated haemoglobin type A1c (HbA1c)</measure>
    <time_frame>Week 0, week 10 (Day 69)</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">107</enrollment>
  <condition>Diabetes</condition>
  <condition>Diabetes Mellitus, Type 2</condition>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Healthy - 20 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy - 40 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy - 60 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>T2D - 20/40/60 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>semaglutide</intervention_name>
    <description>Start doses of 5 mg and 10 mg with end dose of 20 mg. For oral administration.</description>
    <arm_group_label>Healthy - 20 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>semaglutide</intervention_name>
    <description>Start doses of 5 mg and 10 mg with end doses of either 20 mg or 40 mg. For oral administration.</description>
    <arm_group_label>Healthy - 40 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>semaglutide</intervention_name>
    <description>Start doses of 5 mg and 10 mg with end doses of either 20 mg, 40 mg or 60 mg. For oral administration.</description>
    <arm_group_label>Healthy - 60 mg</arm_group_label>
    <arm_group_label>T2D - 20/40/60 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>Placebo semaglutide. For oral administration.</description>
    <arm_group_label>Healthy - 20 mg</arm_group_label>
    <arm_group_label>Healthy - 40 mg</arm_group_label>
    <arm_group_label>Healthy - 60 mg</arm_group_label>
    <arm_group_label>T2D - 20/40/60 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>Placebo semaglutide with carrier. For oral administration.</description>
    <arm_group_label>Healthy - 20 mg</arm_group_label>
    <arm_group_label>Healthy - 40 mg</arm_group_label>
    <arm_group_label>Healthy - 60 mg</arm_group_label>
    <arm_group_label>T2D - 20/40/60 mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male subject, who is considered to be generally healthy, based on the medical history,&#xD;
             physical examination, and the results of vital signs, electrocardiogram (ECG) and&#xD;
             laboratory safety tests performed during the screening visit, as judged by the&#xD;
             investigator. This also applies to subjects with T2D, except for the underlying&#xD;
             diabetes with or without associated hyperlipidaemia and/or hypertension&#xD;
&#xD;
          -  Body mass index (BMI): a) Healthy subjects: above or equal to 20 and below 30 kg/m^2.&#xD;
             b) Subjects with T2D: BMI above or equal to 20 and below or equal to 37 kg/m^2&#xD;
&#xD;
          -  Glycosylated haemoglobin (HbA1c): a) Healthy subjects: below 6.0%. b) Subjects with&#xD;
             T2D: between 6.5 and 9.0% (both inclusive)&#xD;
&#xD;
          -  Additional inclusion criterion only for subjects with T2D: Male subjects with T2D&#xD;
             (diagnosed within the past 10 years) treated with diet and exercise and/or who have&#xD;
             been on stable doses of metformin for at least 12 weeks prior to Visit 3 (Day -1 or 0)&#xD;
             and for whom no changes in treatment are planned for the trial period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of, or presence of, cancer, diabetes (only for healthy subjects) or any&#xD;
             clinically significant cardiovascular (only for healthy subjects), respiratory,&#xD;
             metabolic, renal, hepatic, gastro-intestinal (GI), endocrinological (except diabetes&#xD;
             in subjects with T2D), haematological, dermatological, venereal, neurological,&#xD;
             psychiatric diseases or other major disorders, as judged by the investigator&#xD;
&#xD;
          -  Blood pressure in supine position at the screening examination above: a) 140 mmHg&#xD;
             systolic and/or above 90 mmHg diastolic for healthy subjects. b) 160 mmHg systolic&#xD;
             and/or above 95 mmHg diastolic for subjects with T2D&#xD;
&#xD;
          -  Use of prescription or non-prescription medicinal products (except routine vitamins)&#xD;
             within three weeks preceding the dosing. Occasional use of paracetamol or&#xD;
             acetylsalicylic acid is permitted. a. For subjects with T2D: Any other current&#xD;
             diabetes treatment apart from metformin (e.g. treatment with incretin mimetics,&#xD;
             Dipeptidyl Peptidase-IV (DPP-IV) inhibitors, insulin secretagogues, insulin or&#xD;
             thiazolidinediones (TZDs)). Use of blood lipidregulating agents, as well as blood&#xD;
             pressure regulating, and thrombo-embolic agents is allowed&#xD;
&#xD;
          -  Exclusion criteria only for subjects with T2D:&#xD;
&#xD;
          -  Proliferative retinopathy or maculopathy requiring acute treatment as determined by&#xD;
             funduscopy/fundus photography and judged by the investigator. If subject presents a&#xD;
             medical certificate for funduscopy/fundus photography performed within last 3 months&#xD;
             this can substitute the funduscopy/fundus photography at screening&#xD;
&#xD;
          -  Nephropathy stages 3 to 5, i.e. estimated glomerular filtration rate (eGFR) below 60.&#xD;
             The eGFRshould be determined using the Modification of Diet in Renal Disease&#xD;
             4-variable method encompassing creatinine, age, gender, and race&#xD;
&#xD;
          -  Diabetic peripheral neuropathy using the 10 g Semmes-Weinstein monofilament&#xD;
             examination at the great toe or plantar aspect of the fifth metatarsal&#xD;
&#xD;
          -  Clinically significant active cardiovascular disease including history of myocardial&#xD;
             infarction and/or heart failure (New York Heart Association (NYHA) class III and IV1)&#xD;
             at the discretion of the investigator&#xD;
      </textblock>
    </criteria>
    <gender>Male</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>Berlin</city>
        <zip>14050</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>Seco A, Aparicio S, Gonzalez-Camejo J, Jimenez-Benitez A, Mateo O, Mora JF, Noriega-Hevia G, Sanchis-Perucho P, Serna-Garcia R, Zamorano-Lopez N, Gimenez JB, Ruiz-Martinez A, Aguado D, Barat R, Borras L, Bouzas A, Marti N, Paches M, Ribes J, Robles A, Ruano MV, Serralta J, Ferrer J. Resource recovery from sulphate-rich sewage through an innovative anaerobic-based water resource recovery facility (WRRF). Water Sci Technol. 2018 Dec;78(9):1925-1936. doi: 10.2166/wst.2018.492.</citation>
    <PMID>30566096</PMID>
  </results_reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>September 13, 2012</study_first_submitted>
  <study_first_submitted_qc>September 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <last_update_submitted>January 2, 2019</last_update_submitted>
  <last_update_submitted_qc>January 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 4, 2019</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/NCT01686945
org study id: NN9924-3991
secondary id: 2012-000361-20
secondary id: U1111-1127-4408
nct id: NCT01686945
lead sponsor: 
has dmc: No
This trial is conducted in Europe. The aim of the trial is to investigate safety,
      tolerability, pharmacokinetics (the exposure of the trial drug in the body), and
      pharmacodynamics (the effect of the investigated drug on the body) of multiple doses of a
      long-acting GLP-1 analogue (oral semaglutide) and a carrier in healthy male subjects and male
      subjects with type 2 diabetes (T2D).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Number of treatment emergent adverse events (TEAEs) recorded
time frame: From the time of first dosing and until completion of the post treatment follow-up visits (Day 90 to 104)
measure: Area under the plasma concentration curve over the dosing interval (0-24 hours)
time frame: After the last 3 daily doses for semaglutide and carrier
measure: Change from baseline in fasting plasma glucose (FPG)
time frame: Week 0, week 10 (Day 69)
measure: Change from baseline in C-peptide
time frame: Week 0, week 10 (Day 69)
measure: Change from baseline in insulin
time frame: Week 0, week 10 (Day 69)
measure: Change from baseline in glucagon
time frame: Week 0, week 10 (Day 69)
measure: Change from baseline in glycosylated haemoglobin type A1c (HbA1c)
time frame: Week 0, week 10 (Day 69)
arm group label: Healthy - 20 mg
arm group type: Experimental
arm group label: Healthy - 40 mg
arm group type: Experimental
arm group label: Healthy - 60 mg
arm group type: Experimental
arm group label: T2D - 20/40/60 mg
arm group type: Experimental
intervention type: Drug
intervention name: semaglutide
description: Start doses of 5 mg and 10 mg with end dose of 20 mg. For oral administration.
arm group label: Healthy - 20 mg
intervention type: Drug
intervention name: semaglutide
description: Start doses of 5 mg and 10 mg with end doses of either 20 mg or 40 mg. For oral administration.
arm group label: Healthy - 40 mg
intervention type: Drug
intervention name: semaglutide
description: Start doses of 5 mg and 10 mg with end doses of either 20 mg, 40 mg or 60 mg. For oral administration.
arm group label: Healthy - 60 mg
arm group label: T2D - 20/40/60 mg
intervention type: Drug
intervention name: placebo
description: Placebo semaglutide. For oral administration.
arm group label: Healthy - 20 mg
arm group label: Healthy - 40 mg
arm group label: Healthy - 60 mg
arm group label: T2D - 20/40/60 mg
intervention type: Drug
intervention name: placebo
description: Placebo semaglutide with carrier. For oral administration.
arm group label: Healthy - 20 mg
arm group label: Healthy - 40 mg
arm group label: Healthy - 60 mg
arm group label: T2D - 20/40/60 mg
criteria: 
gender: Male
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
citation: Seco A, Aparicio S, Gonzalez-Camejo J, Jimenez-Benitez A, Mateo O, Mora JF, Noriega-Hevia G, Sanchis-Perucho P, Serna-Garcia R, Zamorano-Lopez N, Gimenez JB, Ruiz-Martinez A, Aguado D, Barat R, Borras L, Bouzas A, Marti N, Paches M, Ribes J, Robles A, Ruano MV, Serralta J, Ferrer J. Resource recovery from sulphate-rich sewage through an innovative anaerobic-based water resource recovery facility (WRRF). Water Sci Technol. 2018 Dec;78(9):1925-1936. doi: 10.2166/wst.2018.492.
PMID: 30566096
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2