<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/NCT03297879</url>
  </required_header>
  <id_info>
    <org_study_id>2015-科 144</org_study_id>
    <nct_id>NCT03297879</nct_id>
  </id_info>
  <brief_title>Comparison of Exenatide and Metformin Monotherapy in Overweight/Obese Patients With Newly Diagnosed Type 2 Diabetes</brief_title>
  <official_title>Beijing Chao-Yang Hospital, Capital Medical University</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Chao Yang Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing Chao Yang Hospital</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 present study assessed the therapeutic effect of exenatide and metformin as the initial&#xD;
      therapy in overweight/obese patients with newly diagnosed Type 2 diabetes (T2D).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The present study was a prospective, nonrandomized, interventional study.The drug-naïve,&#xD;
      overweight or obese patients with newly diagnosed T2D were consecutively enrolled. The&#xD;
      inclusion criteria: 1) age 20 - &lt;65 years, 2) body mass index (BMI) ≥ 24 kg/m2 [7], and 3)&#xD;
      HbA1c ≥ 7% (53mmol/mol). An oral glucose tolerance test was performed during the screenings.&#xD;
      All of the patients have no diabetes antibodies and were diagnosed with T2D within the&#xD;
      previous 3 months, according to the ADA diagnostic criteria. None of the patients had&#xD;
      administered anti-diabetic drugs or diet therapy before participation. Neither of the&#xD;
      patients presented any history of pancreatitis, coronary artery disease, liver function&#xD;
      impairment, renal function impairment, intestinal surgery, chronic hypoxic diseases&#xD;
      (emphysema and cor pulmonale), infectious disease, hematological disease, systemic&#xD;
      inflammatory disease, or cancer. Patients who were pregnant, possibly pregnant, or ingesting&#xD;
      agents known to influence glucose or lipid metabolism were also excluded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2013</start_date>
  <completion_date type="Actual">February 28, 2016</completion_date>
  <primary_completion_date type="Actual">February 28, 2016</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The change of HbA1c</measure>
    <time_frame>baseline and 12 weeks</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">230</enrollment>
  <condition>Type2 Diabetes</condition>
  <arm_group>
    <arm_group_label>exenatide group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The drug-naïve, overweight or obese patients with newly diagnosed T2D</description>
  </arm_group>
  <arm_group>
    <arm_group_label>metformin group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The drug-naïve, overweight or obese patients with newly diagnosed T2D</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Exenatide or metformin hydrochloride</intervention_name>
    <description>Exenatide was administrated with 5 μg bid for 4 weeks and 10 μg bid for 8 weeks. Metformin hydrochloride was initiated at a dose of 500 mg bid for 2 weeks, and added to 2.0 g/day for 8 weeks.</description>
    <arm_group_label>exenatide group</arm_group_label>
    <arm_group_label>metformin group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 20 - &lt;65 years,&#xD;
&#xD;
          -  body mass index (BMI) ≥ 24 kg/m2,&#xD;
&#xD;
          -  HbA1c ≥ 7% (53mmol/mol).&#xD;
&#xD;
          -  diabetes antibodies (-)&#xD;
&#xD;
          -  diagnosed with T2D within the previous 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  anti-diabetic drugs or diet therapy before participation&#xD;
&#xD;
          -  pancreatitis&#xD;
&#xD;
          -  coronary artery disease&#xD;
&#xD;
          -  liver function impairment&#xD;
&#xD;
          -  renal function impairment&#xD;
&#xD;
          -  intestinal surgery&#xD;
&#xD;
          -  chronic hypoxic diseases (emphysema and cor pulmonale)&#xD;
&#xD;
          -  infectious disease&#xD;
&#xD;
          -  hematological disease&#xD;
&#xD;
          -  systemic inflammatory disease&#xD;
&#xD;
          -  cancer&#xD;
&#xD;
          -  pregnant, possibly pregnant&#xD;
&#xD;
          -  ingesting agents known to influence glucose or lipid metabolism&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 26, 2017</study_first_submitted>
  <study_first_submitted_qc>September 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <last_update_submitted>September 29, 2017</last_update_submitted>
  <last_update_submitted_qc>September 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beijing Chao Yang Hospital</investigator_affiliation>
    <investigator_full_name>Guang Wang</investigator_full_name>
    <investigator_title>Director of Endocrinology,Principal Investigator</investigator_title>
  </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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metformin</mesh_term>
    <mesh_term>Exenatide</mesh_term>
  </intervention_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/NCT03297879
org study id: 2015-科 144
nct id: NCT03297879
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The present study assessed the therapeutic effect of exenatide and metformin as the initial
      therapy in overweight/obese patients with newly diagnosed Type 2 diabetes (T2D).
The present study was a prospective, nonrandomized, interventional study.The drug-naïve,
      overweight or obese patients with newly diagnosed T2D were consecutively enrolled. The
      inclusion criteria: 1) age 20 - <65 years, 2) body mass index (BMI) ≥ 24 kg/m2 [7], and 3)
      HbA1c ≥ 7% (53mmol/mol). An oral glucose tolerance test was performed during the screenings.
      All of the patients have no diabetes antibodies and were diagnosed with T2D within the
      previous 3 months, according to the ADA diagnostic criteria. None of the patients had
      administered anti-diabetic drugs or diet therapy before participation. Neither of the
      patients presented any history of pancreatitis, coronary artery disease, liver function
      impairment, renal function impairment, intestinal surgery, chronic hypoxic diseases
      (emphysema and cor pulmonale), infectious disease, hematological disease, systemic
      inflammatory disease, or cancer. Patients who were pregnant, possibly pregnant, or ingesting
      agents known to influence glucose or lipid metabolism were also excluded.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The change of HbA1c
time frame: baseline and 12 weeks
arm group label: exenatide group
arm group type: Experimental
description: The drug-naïve, overweight or obese patients with newly diagnosed T2D
arm group label: metformin group
arm group type: Active Comparator
description: The drug-naïve, overweight or obese patients with newly diagnosed T2D
intervention type: Drug
intervention name: Exenatide or metformin hydrochloride
description: Exenatide was administrated with 5 μg bid for 4 weeks and 10 μg bid for 8 weeks. Metformin hydrochloride was initiated at a dose of 500 mg bid for 2 weeks, and added to 2.0 g/day for 8 weeks.
arm group label: exenatide group
arm group label: metformin group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Beijing Chao Yang Hospital
investigator full name: Guang Wang
investigator title: Director of Endocrinology,Principal Investigator
mesh term: Diabetes Mellitus, Type 2
mesh term: Metformin
mesh term: Exenatide