xml: <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/NCT05990374</url>
    </required_header>
    <id_info>
      <org_study_id>KY20220825-04</org_study_id>
      <nct_id>NCT05990374</nct_id>
    </id_info>
    <brief_title>Therapeutic Effects and Effects on Body Fat of GLP-1 Receptor Agonists in Patients With Type 2 Diabetes for 1-4 Years</brief_title>
    <official_title>Therapeutic Effects and Effects on Body Fat of GLP-1 Receptor Agonists in Patients With Type 2 Diabetes for 1-4 Years</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Nanjing First Hospital, Nanjing Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Nanjing First Hospital, Nanjing Medical University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The efficacy of long-term treatment with different GLP-1RA (Duragtide, Semaglutide,&#xD;
        losenatide, tirzepatide, ebenatide, etc.) was evaluated through 1-4 years of follow-up, and&#xD;
        the effects of long-term treatment on blood glucose and body fat of patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        At present, there has been no evaluation on the efficacy of long-term treatment of different&#xD;
        GLP-1RA (Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc.), and the effects&#xD;
        of long-term treatment on patients' blood glucose and body fat. This study intends to follow&#xD;
        up for 1-4 years. To observe the effects of different GLP-1RA on body fat, insulin&#xD;
        resistance, body weight, blood glucose, blood lipids, stomach volume, etc., in patients with&#xD;
        type 2 diabetes, and explore the factors affecting the efficacy, so as to provide more&#xD;
        evidence-based medical evidence for drug treatment and benefit patients.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">January 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2024</primary_completion_date>
    <phase>N/A</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>Triple (Participant, Care Provider, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Effects of different GLP-1 on blood glucose</measure>
      <time_frame>1,2,3,4 year</time_frame>
      <description>The changes of blood glucose fluctuation after treatment</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Effects of different GLP-1 on body fat mass</measure>
      <time_frame>1,2,3,4 year</time_frame>
      <description>The changes of body fat mass after treatment</description>
    </secondary_outcome>
    <number_of_arms>7</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Diabetes</condition>
    <arm_group>
      <arm_group_label>Dulaglutide</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Once a week, subcutaneous injection</description>
    </arm_group>
    <arm_group>
      <arm_group_label>semaglutide</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Once a week, subcutaneous injection</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Loseenatide</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Once a week, subcutaneous injection</description>
    </arm_group>
    <arm_group>
      <arm_group_label>tirzepatide</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Once a week, subcutaneous injection</description>
    </arm_group>
    <arm_group>
      <arm_group_label>elbenatide</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Once a week, subcutaneous injection</description>
    </arm_group>
    <arm_group>
      <arm_group_label>original treatment</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Once a week, subcutaneous injection</description>
    </arm_group>
    <arm_group>
      <arm_group_label>placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>The patients will be treated according to the original protocol</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc</intervention_name>
      <description>The study compared patients taking different types of GLP-1(Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc) with taking placebo.</description>
      <arm_group_label>Dulaglutide</arm_group_label>
      <arm_group_label>Loseenatide</arm_group_label>
      <arm_group_label>elbenatide</arm_group_label>
      <arm_group_label>original treatment</arm_group_label>
      <arm_group_label>placebo</arm_group_label>
      <arm_group_label>semaglutide</arm_group_label>
      <arm_group_label>tirzepatide</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Diagnosed type 2 diabetes according to the 1999 WHO standards;&#xD;
  &#xD;
            2. received at least 8 weeks of simple diet control and physical exercise before&#xD;
               screening; Patients with type 2 diabetes who were treated with stable hypoglycemic&#xD;
               drugs and had inadequate glycemic control within 8 weeks prior to screening;&#xD;
  &#xD;
            3. HbA1c≥7.5%；&#xD;
  &#xD;
            4. BMI&gt;24kg/m2;&#xD;
  &#xD;
            5. Subjects agree to maintain a scientific diet and exercise habits throughout the study,&#xD;
               and regularly self-monitor and record blood sugar (SMBG);&#xD;
  &#xD;
            6. Be willing to sign written informed consent and comply with the study protocol&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Use of any of the following drugs or treatments in the 3 months prior to screening:&#xD;
               treatment with GLP-1RA, GLP-1 analogue, DPP-4 inhibitor, or any other incretin&#xD;
               analogue;&#xD;
  &#xD;
            2. Long-term (more than 7 consecutive days) intravenous administration, oral&#xD;
               administration, or intra-articular administration of corticosteroids within 2 months&#xD;
               prior to screening;&#xD;
  &#xD;
            3. Use of weight control drugs or surgery that can lead to weight instability within 2&#xD;
               months before screening, or are currently in a weight loss program and not in the&#xD;
               maintenance stage:&#xD;
  &#xD;
            4. History of acute and chronic pancreatitis; A history of medullary C-cell carcinoma,&#xD;
               MEN (multiple endocrine tumors) 2A or 2B syndrome, or related family history;&#xD;
  &#xD;
            5. Clinically significant gastric emptying abnormalities;&#xD;
  &#xD;
            6. tumors of any organ system that have been treated or not treated in the 5 years prior&#xD;
               to screening;&#xD;
  &#xD;
            7. had received coronary angioplasty, coronary stenting, or coronary artery bypass within&#xD;
               6 months before screening. Negligent compensatory heart failure (NYHA rating III and&#xD;
               IV), stroke or transient ischemic attack, unstable angina, myocardial infarction,&#xD;
               persistent and clinically significant arrhythmia;&#xD;
  &#xD;
            8. Acute metabolic complications occurred within 6 months before screening;&#xD;
  &#xD;
            9. Before screening, any of the laboratory test indicators meet the following criteria:&#xD;
               glutamic-pyrugenic transaminase &gt;2.5 times or ASpartate transaminase &gt;2.5 times; eGFR&#xD;
               &lt;45ml/min/1.73m2; Fasting glycerin tricol &gt;5.64mmol/L.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Bingli Liu</last_name>
      <phone>+86 15366110069</phone>
      <email>lxmxjtu@sina.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Nanjing First Hospital, Nanjing Medical Univesity</name>
        <address>
          <city>Nanjing</city>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jianhua Ma, Professor</last_name>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>July 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 6, 2023</last_update_submitted>
    <last_update_submitted_qc>August 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</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>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Tirzepatide</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05990374
  org study id: KY20220825-04
  nct id: NCT05990374
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The efficacy of long-term treatment with different GLP-1RA (Duragtide, Semaglutide,
        losenatide, tirzepatide, ebenatide, etc.) was evaluated through 1-4 years of follow-up, and
        the effects of long-term treatment on blood glucose and body fat of patients.
  At present, there has been no evaluation on the efficacy of long-term treatment of different
        GLP-1RA (Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc.), and the effects
        of long-term treatment on patients' blood glucose and body fat. This study intends to follow
        up for 1-4 years. To observe the effects of different GLP-1RA on body fat, insulin
        resistance, body weight, blood glucose, blood lipids, stomach volume, etc., in patients with
        type 2 diabetes, and explore the factors affecting the efficacy, so as to provide more
        evidence-based medical evidence for drug treatment and benefit patients.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Care Provider, Investigator)
  measure: Effects of different GLP-1 on blood glucose
  time frame: 1,2,3,4 year
  description: The changes of blood glucose fluctuation after treatment
  measure: Effects of different GLP-1 on body fat mass
  time frame: 1,2,3,4 year
  description: The changes of body fat mass after treatment
  arm group label: Dulaglutide
  arm group type: Active Comparator
  description: Once a week, subcutaneous injection
  arm group label: semaglutide
  arm group type: Active Comparator
  description: Once a week, subcutaneous injection
  arm group label: Loseenatide
  arm group type: Active Comparator
  description: Once a week, subcutaneous injection
  arm group label: tirzepatide
  arm group type: Active Comparator
  description: Once a week, subcutaneous injection
  arm group label: elbenatide
  arm group type: Active Comparator
  description: Once a week, subcutaneous injection
  arm group label: original treatment
  arm group type: Active Comparator
  description: Once a week, subcutaneous injection
  arm group label: placebo
  arm group type: Placebo Comparator
  description: The patients will be treated according to the original protocol
  intervention type: Drug
  intervention name: Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc
  description: The study compared patients taking different types of GLP-1(Duragtide, Semaglutide, losenatide, tirzepatide, ebenatide, etc) with taking placebo.
  arm group label: Dulaglutide
  arm group label: Loseenatide
  arm group label: elbenatide
  arm group label: original treatment
  arm group label: placebo
  arm group label: semaglutide
  arm group label: tirzepatide
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Bingli Liu
  phone: +86 15366110069
  email: lxmxjtu@sina.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Diabetes Mellitus
  mesh term: Tirzepatide