<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/NCT04447859</url>
  </required_header>
  <id_info>
    <org_study_id>0631-19</org_study_id>
    <nct_id>NCT04447859</nct_id>
  </id_info>
  <brief_title>16-week Flexible vs. 8-week Semaglutide Titration</brief_title>
  <official_title>A Randomized Controlled Open Label Pilot Study Examining the Safety of a 16 Week Flexible Titration Regimen vs. Label-recommended 8-week Semaglutide Titration Regimen</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tel-Aviv Sourasky Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tel-Aviv Sourasky Medical Center</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Semaglutide is a Glucagon Like Peptide 1 (GLP-1) receptor agonist recently approved in Israel&#xD;
      to improve glycemic control in patients with type 2 diabetes mellitus. Semaglutide is&#xD;
      currently administered as a weekly subcutaneous injection.Treatment with semaglutide is&#xD;
      associated with the occurrence of gastrointestinal adverse events (GI-AEs) commonly observed&#xD;
      during GLP-1 receptor agonist treatment. The most common adverse reactions, reported in ≥5%&#xD;
      of patients treated with semaglutide are nausea, vomiting, diarrhea, abdominal pain and&#xD;
      constipation.&#xD;
&#xD;
      In this trial we plan to explore the effect of a slower titration regimen of semaglutide vs.&#xD;
      the current label-recommended dose escalation regimen on the occurrence of GI-AEs.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 23, 2020</start_date>
  <completion_date type="Anticipated">September 10, 2022</completion_date>
  <primary_completion_date type="Anticipated">May 10, 2022</primary_completion_date>
  <phase>Phase 3</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Gastrointestinal adverse events (GI-AEs)</measure>
    <time_frame>16 weeks - from visit one to visit seven (and in each visit alone)</time_frame>
    <description>% occurrence of GI-AEs over time (pooled nausea, vomiting, diarrhea and every component alone)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Diabetes type2</condition>
  <arm_group>
    <arm_group_label>label recommended titration</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>eight-week titration regimen as recommended in by the product label (0.25mg/week for 4 weeks, 0.5mg/week for 4 weeks, 1mg/week for the remainder of the therapy)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Slow semaglutide titration</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A slower 16-week titration regimen (initiate treatment at 0.0675mg/week and increase the dose by 0.0675mg weekly until a dose of 1mg/week is reached)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Semaglutide</intervention_name>
    <description>Slow semaglutide titration group vs. label recommended titration group (16-week flexible vs. 8-week semaglutide titration)</description>
    <arm_group_label>Slow semaglutide titration</arm_group_label>
    <other_name>Ozempic</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>label recommended titration</intervention_name>
    <description>label recommended titration</description>
    <arm_group_label>label recommended titration</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have personally signed and dated the informed consent form indicating that he/she has&#xD;
             been informed of all pertinent aspects of the trial.&#xD;
&#xD;
          -  Be willing and able to comply with the scheduled visits and other study procedures.&#xD;
&#xD;
          -  Meet one of the following categories:&#xD;
&#xD;
               1. The subject is a male.&#xD;
&#xD;
               2. The subject is a female who is not of reproductive potential, defined as a female&#xD;
                  who either: (1) is postmenopausal (defined as at least 12 months with no menses&#xD;
                  in women ≥45 years of age); (2) has had a hysterectomy and/or bilateral&#xD;
                  oophorectomy, bilateral salpingectomy, or bilateral tubal ligation/occlusion at&#xD;
                  least 6 weeks prior to screening; OR (3) has a congenital or acquired condition&#xD;
                  that prevents childbearing.&#xD;
&#xD;
               3. The subject is a female who is of reproductive potential and agrees to avoid&#xD;
                  becoming pregnant: while receiving study drug and for 60 days after the last dose&#xD;
                  of study drug by complying with one of the following: (1) practice abstinence†&#xD;
                  from heterosexual activity OR (2) use (or have her partner use) acceptable&#xD;
                  contraception during heterosexual activity. Acceptable methods of contraception&#xD;
                  are‡:&#xD;
&#xD;
        Single method (one of the following is acceptable):&#xD;
&#xD;
          -  non-hormonal intrauterine device (IUD)&#xD;
&#xD;
          -  vasectomy of a female subject's male partner&#xD;
&#xD;
        Combination method (requires use of two of the following):&#xD;
&#xD;
          -  diaphragm with spermicide (cannot be used in conjunction with cervical cap/spermicide)&#xD;
&#xD;
          -  cervical cap with spermicide (nulliparous women only)&#xD;
&#xD;
          -  contraceptive sponge (nulliparous women only)&#xD;
&#xD;
          -  male condom or female condom (cannot be used together)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has a known contraindication to use of GLP-1 agonists.&#xD;
&#xD;
          -  Has been treated with a GLP-1 agonist in the last 30 days.&#xD;
&#xD;
          -  Has a history of type 1 diabetes mellitus&#xD;
&#xD;
          -  Has a medical history of untreated active proliferative retinopathy.&#xD;
&#xD;
          -  Has other severe acute or chronic medical or psychiatric condition or laboratory&#xD;
             abnormality that may increase the risk associated with study participation or blinded&#xD;
             investigational product administration or may interfere with the interpretation of&#xD;
             study results and, in the judgment of the investigator, would make the subject&#xD;
             inappropriate for entry into this trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Roy Eldor, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tel Aviv Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Roy Eldor, MD PhD</last_name>
    <phone>+972-52-736-0680</phone>
    <email>roye@tlvmc.gov.il</email>
  </overall_contact>
  <location>
    <facility>
      <name>Tel-Aviv Medical Center</name>
      <address>
        <city>Tel Aviv</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Roy Eldor, MD PhD</last_name>
      <phone>+972-52-736-0680</phone>
      <email>roye@tlvmc.gov.il</email>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>June 24, 2020</last_update_submitted>
  <last_update_submitted_qc>June 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 25, 2020</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, 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/NCT04447859
org study id: 0631-19
nct id: NCT04447859
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Semaglutide is a Glucagon Like Peptide 1 (GLP-1) receptor agonist recently approved in Israel
      to improve glycemic control in patients with type 2 diabetes mellitus. Semaglutide is
      currently administered as a weekly subcutaneous injection.Treatment with semaglutide is
      associated with the occurrence of gastrointestinal adverse events (GI-AEs) commonly observed
      during GLP-1 receptor agonist treatment. The most common adverse reactions, reported in ≥5%
      of patients treated with semaglutide are nausea, vomiting, diarrhea, abdominal pain and
      constipation.

      In this trial we plan to explore the effect of a slower titration regimen of semaglutide vs.
      the current label-recommended dose escalation regimen on the occurrence of GI-AEs.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Gastrointestinal adverse events (GI-AEs)
time frame: 16 weeks - from visit one to visit seven (and in each visit alone)
description: % occurrence of GI-AEs over time (pooled nausea, vomiting, diarrhea and every component alone)
arm group label: label recommended titration
arm group type: Active Comparator
description: eight-week titration regimen as recommended in by the product label (0.25mg/week for 4 weeks, 0.5mg/week for 4 weeks, 1mg/week for the remainder of the therapy)
arm group label: Slow semaglutide titration
arm group type: Experimental
description: A slower 16-week titration regimen (initiate treatment at 0.0675mg/week and increase the dose by 0.0675mg weekly until a dose of 1mg/week is reached)
intervention type: Drug
intervention name: Semaglutide
description: Slow semaglutide titration group vs. label recommended titration group (16-week flexible vs. 8-week semaglutide titration)
arm group label: Slow semaglutide titration
other name: Ozempic
intervention type: Other
intervention name: label recommended titration
description: label recommended titration
arm group label: label recommended titration
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Roy Eldor, MD PhD
role: Principal Investigator
affiliation: Tel Aviv Medical Center
last name: Roy Eldor, MD PhD
phone: +972-52-736-0680
email: roye@tlvmc.gov.il
facility: 
status: Recruiting
contact: 
country: Israel
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 2