<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/NCT03018665</url>
  </required_header>
  <id_info>
    <org_study_id>JLUEND001</org_study_id>
    <nct_id>NCT03018665</nct_id>
  </id_info>
  <brief_title>A Study of the Effect of Glucagon-like Peptide 1(GLP-1) Receptor Agonist in Combination With Metformin Therapy on Diabetes Remission in Subjects With Newly Diagnosed Type 2 Diabetes Who Are Overweight or Obese</brief_title>
  <official_title>A Randomized,Active-controlled,Open-label Clinical Trial to Evaluate the Effect of GLP-1 Receptor Agonist (Exenatide Injection) in Combination With Metformin Therapy Compared to Premixed Insulin (BIAsp30) in Combination With Metformin Therapy on Diabetes Remission in Subjects With Newly Diagnosed Type 2 Diabetes Who Are Overweight or Obese</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First Hospital of Jilin University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The First Hospital of Jilin University</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the effect of GLP-1 receptor agonist on inducing&#xD;
      diabetes remission in newly diagnosed type 2 diabetes who are overweight or obese&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Most of type 2 diabetes are characterized by being overweight or obese mainly caused by&#xD;
      insulin resistance. GLP-1 receptor agonist has been proved to help to lose weight and improve&#xD;
      insulin resistance. In this study, we suppose that GLP-1 receptor agonist has the effect of&#xD;
      inducing diabetes remission in newly diagnosed type 2 diabetes who are overweight or obese&#xD;
      and has its advantages&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>February 2017</start_date>
  <primary_completion_date type="Anticipated">December 2021</primary_completion_date>
  <phase>Phase 4</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>Rate of Inducing Diabetes Remission</measure>
    <time_frame>At the end of 12-week treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of Rate of Maintaining Diabetes Remission</measure>
    <time_frame>3,6,12,24,36 months after 12-week treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time of Maintaining Diabetes Remission</measure>
    <time_frame>up to 36 months after 12-week treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of Blood Pressure</measure>
    <time_frame>Baseline and 0,3,6,12,24,36 months after 12-week treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Heart Rate</measure>
    <time_frame>baseline and 0,3,6,12,24,36 months after 12-week treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Weight</measure>
    <time_frame>baseline and 0,3,6,12,24,36 months after 12-week treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Waistline</measure>
    <time_frame>baseline and 0,3,6,12,24,36 months after 12-week treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Glycosylated Hemoglobin</measure>
    <time_frame>baseline and 0,3,6,12,24,36 months after 12-week treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Pancreatic Beta-cell Function</measure>
    <time_frame>baseline and 0,3,6,12,24,36 months after 12-week treatment</time_frame>
    <description>Pancreatic Beta-cell Function will be evaluated by insulin releasing test. The fasting and 2-hour postprandial plasma glucose concentrations and serum insulin concentrations will be tested.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Insulin Resistance Index</measure>
    <time_frame>baseline and 0,3,6,12,24,36 months after 12-week treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Incidence of Hypoglycemia</measure>
    <time_frame>During the 12-week treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Incidence of Diabetic Retinopathy</measure>
    <time_frame>up to 36 months after 12-week treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Incidence of Diabetic Nephropathy</measure>
    <time_frame>up to 36 months after 12-week treatment</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Exenatide and Metformin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Exenatide in Combination With Metformin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BIAsp30 and Metformin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>BIAsp30 in Combination With Metformin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Exenatide</intervention_name>
    <description>subcutaneous injection，5ug twice a day the first month，10ug twice a day the second and third month</description>
    <arm_group_label>Exenatide and Metformin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BIAsp30</intervention_name>
    <description>subcutaneous injection，fit dosage twice a day in three months</description>
    <arm_group_label>BIAsp30 and Metformin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metformin</intervention_name>
    <description>oral，0.85g，twice a day in three months</description>
    <arm_group_label>BIAsp30 and Metformin</arm_group_label>
    <arm_group_label>Exenatide and Metformin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A signed and dated informed consent form obtained from the subject before any study&#xD;
             related procedures take place.&#xD;
&#xD;
          -  Age ≥18 years to ≤65 years at Visit 1.&#xD;
&#xD;
          -  The subject has a new diagnosis of type 2 diabetes without any treatment.&#xD;
&#xD;
          -  HbA1c ≥8.0% to ≤14.0% at Visit 1.&#xD;
&#xD;
          -  BMI(Body Mass Index)≥24kg/m2 to ≤40kg/m2 at Visit 1.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The subject has a history of type 1 diabetes or a secondary form of diabetes.&#xD;
&#xD;
          -  The subject has received an anti-diabetic drug before the screening visit.&#xD;
&#xD;
          -  Treatment with systemic steroids 2 months prior to screening&#xD;
&#xD;
          -  Treatment with anti-obesity drug 2 months prior to screening or any other treatment at&#xD;
             the time of screening(i.e. surgery etc) leading to unstable body weight.&#xD;
&#xD;
          -  The subject has a history of acute or chronic pancreatitis&#xD;
&#xD;
          -  Any gastrointestinal diseases or surgeries that induce chronic malabsorption&#xD;
&#xD;
          -  Cancer and medical history of cancer(except basal cell skin cancer or squamous cell&#xD;
             skin cancer).&#xD;
&#xD;
          -  The subject has a history of recurrent severe hypoglycaemia.&#xD;
&#xD;
          -  Cardiovascular disease,within the last 6months prior to screening,defined as:&#xD;
             stroke;decompensated heart failure New York Heart Association(NYHA) class III or&#xD;
             IV;Myocardial infarction;unstable angina pectoris;or coronary bypass graft or&#xD;
             angioplasty.&#xD;
&#xD;
          -  Uncontrolled treated/untreated severe hypertension (systolic blood pressure ≥180&#xD;
             millimetre(mm) mercury(Hg) and/or diastolic blood pressure ≥100 millimetre(mm)&#xD;
             mercury(Hg).&#xD;
&#xD;
          -  Impaired liver function,defined as alanine aminotransferase(ALT) or aspartate&#xD;
             aminotransferase(AST) ≥2.5 times upper limit of normal.&#xD;
&#xD;
          -  Impaired renal function,defined as serum-creatinine ≥125umol/l for males and&#xD;
             ≥110umol/l for females.&#xD;
&#xD;
          -  Females who are pregnant or breast-feeding, males and females of childbearing&#xD;
             potential,who do not agree to prevent conception during the study.&#xD;
&#xD;
          -  Known or suspected abuse of alcohol,narcotics or illicit drugs.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guixia Wang, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The First Hospital of Jilin University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Guixia Wang, PhD</last_name>
    <email>gwang168@jlu.edu.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>First Hospital of Jilin University</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <zip>130021</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Guixia Wang, PhD</last_name>
      <email>gwang168@jlu.edu.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 9, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>January 10, 2017</last_update_submitted>
  <last_update_submitted_qc>January 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The First Hospital of Jilin University</investigator_affiliation>
    <investigator_full_name>Guixia Wang</investigator_full_name>
    <investigator_title>Director of Endocrinology Department</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Overweight</mesh_term>
    <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/NCT03018665
org study id: JLUEND001
nct id: NCT03018665
lead sponsor: 
The purpose of this study is to determine the effect of GLP-1 receptor agonist on inducing
      diabetes remission in newly diagnosed type 2 diabetes who are overweight or obese
Most of type 2 diabetes are characterized by being overweight or obese mainly caused by
      insulin resistance. GLP-1 receptor agonist has been proved to help to lose weight and improve
      insulin resistance. In this study, we suppose that GLP-1 receptor agonist has the effect of
      inducing diabetes remission in newly diagnosed type 2 diabetes who are overweight or obese
      and has its advantages
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Rate of Inducing Diabetes Remission
time frame: At the end of 12-week treatment
measure: Change of Rate of Maintaining Diabetes Remission
time frame: 3,6,12,24,36 months after 12-week treatment
measure: Time of Maintaining Diabetes Remission
time frame: up to 36 months after 12-week treatment
measure: Change of Blood Pressure
time frame: Baseline and 0,3,6,12,24,36 months after 12-week treatment
measure: Change of Heart Rate
time frame: baseline and 0,3,6,12,24,36 months after 12-week treatment
measure: Change of Weight
time frame: baseline and 0,3,6,12,24,36 months after 12-week treatment
measure: Change of Waistline
time frame: baseline and 0,3,6,12,24,36 months after 12-week treatment
measure: Change of Glycosylated Hemoglobin
time frame: baseline and 0,3,6,12,24,36 months after 12-week treatment
measure: Change of Pancreatic Beta-cell Function
time frame: baseline and 0,3,6,12,24,36 months after 12-week treatment
description: Pancreatic Beta-cell Function will be evaluated by insulin releasing test. The fasting and 2-hour postprandial plasma glucose concentrations and serum insulin concentrations will be tested.
measure: Change of Insulin Resistance Index
time frame: baseline and 0,3,6,12,24,36 months after 12-week treatment
measure: The Incidence of Hypoglycemia
time frame: During the 12-week treatment
measure: The Incidence of Diabetic Retinopathy
time frame: up to 36 months after 12-week treatment
measure: The Incidence of Diabetic Nephropathy
time frame: up to 36 months after 12-week treatment
arm group label: Exenatide and Metformin
arm group type: Experimental
description: Exenatide in Combination With Metformin
arm group label: BIAsp30 and Metformin
arm group type: Active Comparator
description: BIAsp30 in Combination With Metformin
intervention type: Drug
intervention name: Exenatide
description: subcutaneous injection，5ug twice a day the first month，10ug twice a day the second and third month
arm group label: Exenatide and Metformin
intervention type: Drug
intervention name: BIAsp30
description: subcutaneous injection，fit dosage twice a day in three months
arm group label: BIAsp30 and Metformin
intervention type: Drug
intervention name: Metformin
description: oral，0.85g，twice a day in three months
arm group label: BIAsp30 and Metformin
arm group label: Exenatide and Metformin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Guixia Wang, PhD
role: Principal Investigator
affiliation: The First Hospital of Jilin University
last name: Guixia Wang, PhD
email: gwang168@jlu.edu.cn
facility: 
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: The First Hospital of Jilin University
investigator full name: Guixia Wang
investigator title: Director of Endocrinology Department
mesh term: Diabetes Mellitus
mesh term: Overweight
mesh term: Diabetes Mellitus, Type 2
mesh term: Metformin
mesh term: Exenatide