<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/NCT03239119</url>
  </required_header>
  <id_info>
    <org_study_id>rE-4201706/PRO</org_study_id>
    <nct_id>NCT03239119</nct_id>
  </id_info>
  <brief_title>The Effectivity and Safety Study of rExenatide-4 in Chinese Type 2 Diabetes Mellitus</brief_title>
  <official_title>A Phase 3, Randomized, Double-Blind,Placebo-Controlled, Multicenter Study to Examine the Effect on Glucose Control (HbA1c) and Safety of rE-4 in Subjects With Type 2 Diabetes Mellitus Treated With Metformin, a Sulfonylurea, or Metformin and Sulfonylurea Combination</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CSPC ZhongQi Pharmaceutical Technology Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CSPC ZhongQi Pharmaceutical Technology Co., Ltd.</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>
      This research is a randomized, double-blind,controlled trial. 456 Chinese subjects with Type&#xD;
      2 Diabetes Mellitus will be enrolled in the trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multicenter, randomized, blinded, placebo-controlled study to assess the effects on&#xD;
      glucose control of rE-4 as compared to placebo in patients with type 2 diabetes. Patients&#xD;
      will be randomized into one of two rE-4 treatment arms or to placebo treatment and will&#xD;
      continue with their required existing diabetes medications (metformin, a sulfonylurea or&#xD;
      metformin and a sulfonylurea combination) throughout the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">November 30, 2017</start_date>
  <completion_date type="Anticipated">January 15, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2018</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in HbA1c from Baseline to Week 30</measure>
    <time_frame>Baseline (Day 1) to Week 30</time_frame>
    <description>Change in HbA1c from Baseline (Day 1) to study termination (Week 30)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The number of subjects achieving HbA1c target values of &lt; 7% and ≤ 6.5% by Week 30</measure>
    <time_frame>Baseline (Day 1) and Week 30</time_frame>
    <description>The number of subjects achieving HbA1c target values of &lt; 7% and ≤ 6.5% by study termination (Week 30)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in body weight from Baseline to each intermediate visit and Week 30</measure>
    <time_frame>Baseline (Day 1), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 30</time_frame>
    <description>Change in body weight (kg) from Baseline to each intermediate visit and Week 30</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in FPG from Baseline to each intermediate visit and Week 30</measure>
    <time_frame>Baseline (Day 1), Week 2, Week 4, Week, 6, Week 12, Week 18, Week 24, Week 30</time_frame>
    <description>Change in Fasting Plasma Glucose from Baseline to each intermediate visit and Week 30</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in 7-SMBG from Baseline to Week 16，Week 24 and Week 30</measure>
    <time_frame>Baseline, Week 16，Week 24 and Week 30</time_frame>
    <description>Change in glucose measurements before and 2h after the start of the morning,midday,and evening meals, and at bedtime from Baseline to Week 16，Week 24 and Week 30</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">456</enrollment>
  <condition>Type2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>rE-4 5 mcg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Placebo, then rE-4 5 mcg, then rE-4 5 mcg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>rE-4 10 mcg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Placebo, then rE-4 5 mcg, then rE-4 10 mcg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo 5 mcg</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo 5 mcg, then Placebo 5 mcg, then Placebo 5 mcg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo 10 mcg</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo 5 mcg, then Placebo 5 mcg, then Placebo 10 mcg</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>rE-4 5 mcg</intervention_name>
    <description>Placebo Lead In (5 mcg) for 4 weeks / rE-4 5 mcg for 4 weeks / rE-4 5 mcg for 26 weeks - All are subcutaneously injected twice daily</description>
    <arm_group_label>rE-4 5 mcg</arm_group_label>
    <other_name>rExenatide-4</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>rE-4 10 mcg</intervention_name>
    <description>Placebo Lead In (5 mcg) for 4 weeks / rE-4 5 mcg for 4 weeks / rE-4 10 mcg for 26 weeks - All are subcutaneously injected twice daily</description>
    <arm_group_label>rE-4 10 mcg</arm_group_label>
    <other_name>rExenatide-4</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo 5 mcg</intervention_name>
    <description>Placebo Lead In (5 mcg) for 4 weeks / Placebo 5 mcg for 4 weeks / Placebo 5 mcg for 26 weeks - All are subcutaneously injected twice daily</description>
    <arm_group_label>Placebo 5 mcg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo 10 mcg</intervention_name>
    <description>Placebo Lead In (5 mcg) for 4 weeks / Placebo 5 mcg for 4 weeks / Placebo 10 mcg for 26 weeks - All are subcutaneously injected twice daily</description>
    <arm_group_label>Placebo 10 mcg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. T2DM&#xD;
&#xD;
          2. 7.0% ≤ HbA1c ≤ 11.0% at screening&#xD;
&#xD;
          3. FPG ≤13.8 mmol/L&#xD;
&#xD;
          4. 19 kg/m2 &lt; BMI &lt;35.0 kg/m2 at screening&#xD;
&#xD;
          5. All subjects provided written informed consent before participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. T1DM&#xD;
&#xD;
          2. Patients treated previously with Exenatide or GLP-1 similar&#xD;
&#xD;
          3. At screening visit alanine aminotransferase (ALT) or alkaline phosphatase (AST) more&#xD;
             than 2.5 ULN&#xD;
&#xD;
          4. At screening visit estimated glomerular filtration rate (eGFR) ≤ 60 mL/min or&#xD;
             Triglyceride(TG)≥ 5 mmol/L&#xD;
&#xD;
          5. Pancreatitis, cholecystitis, gallstones and other gastrointestinal diseases&#xD;
&#xD;
          6. Within the last 12 months prior to screening visit: history of stroke, myocardial&#xD;
             infarction, unstable angina, or heart failure requiring hospitalization. Planned&#xD;
             coronary, carotid or peripheral artery revascularisation procedures to be performed&#xD;
             during the study period&#xD;
&#xD;
          7. History of digestive diseases (e.g.pancreatitis, cholecystitis or gallstones)&#xD;
&#xD;
          8. Patients with severe renal impairment or end-stage renal disease&#xD;
&#xD;
          9. Uncontrolled or inadequately controlled hypertension (systolic blood pressure above&#xD;
             180 mmHg or diastolic blood pressure above 110 mmHg) at screening visit.&#xD;
&#xD;
         10. Use of weight loss drugs within 3 months prior to screening visit&#xD;
&#xD;
         11. Have been treated with exogenous insulin, α-glucosidase, corticosteroid, DPP-4&#xD;
             inhibitor or pramlintide acetate within the 3 months prior to screening.&#xD;
&#xD;
         12. Severe gastrointestinal disease (e.g., gastroparesis)&#xD;
&#xD;
         13. Pregnancy or lactation, women of childbearing potential with no effective&#xD;
             contraceptive method&#xD;
&#xD;
         14. Participant who participated in any drug clinical trial within the last 3 months prior&#xD;
             to screening visit&#xD;
&#xD;
         15. History of severe hypersensitivity to rExenatide-4 or any product components&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>linong Ji, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University People's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>linong Ji, Ph.D</last_name>
    <phone>+86-01088325578</phone>
    <email>jiln@bjmu.edu.cn</email>
  </overall_contact>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>August 2, 2017</last_update_submitted>
  <last_update_submitted_qc>August 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>rE-4</keyword>
  <keyword>Exenatide</keyword>
  <keyword>Metformin</keyword>
  <keyword>Sulfonylurea</keyword>
  <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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03239119
org study id: rE-4201706/PRO
nct id: NCT03239119
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This research is a randomized, double-blind,controlled trial. 456 Chinese subjects with Type
      2 Diabetes Mellitus will be enrolled in the trial.
This is a multicenter, randomized, blinded, placebo-controlled study to assess the effects on
      glucose control of rE-4 as compared to placebo in patients with type 2 diabetes. Patients
      will be randomized into one of two rE-4 treatment arms or to placebo treatment and will
      continue with their required existing diabetes medications (metformin, a sulfonylurea or
      metformin and a sulfonylurea combination) throughout the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change in HbA1c from Baseline to Week 30
time frame: Baseline (Day 1) to Week 30
description: Change in HbA1c from Baseline (Day 1) to study termination (Week 30)
measure: The number of subjects achieving HbA1c target values of < 7% and ≤ 6.5% by Week 30
time frame: Baseline (Day 1) and Week 30
description: The number of subjects achieving HbA1c target values of < 7% and ≤ 6.5% by study termination (Week 30)
measure: Change in body weight from Baseline to each intermediate visit and Week 30
time frame: Baseline (Day 1), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 30
description: Change in body weight (kg) from Baseline to each intermediate visit and Week 30
measure: Change in FPG from Baseline to each intermediate visit and Week 30
time frame: Baseline (Day 1), Week 2, Week 4, Week, 6, Week 12, Week 18, Week 24, Week 30
description: Change in Fasting Plasma Glucose from Baseline to each intermediate visit and Week 30
measure: Change in 7-SMBG from Baseline to Week 16，Week 24 and Week 30
time frame: Baseline, Week 16，Week 24 and Week 30
description: Change in glucose measurements before and 2h after the start of the morning,midday,and evening meals, and at bedtime from Baseline to Week 16，Week 24 and Week 30
arm group label: rE-4 5 mcg
arm group type: Experimental
description: Placebo, then rE-4 5 mcg, then rE-4 5 mcg
arm group label: rE-4 10 mcg
arm group type: Experimental
description: Placebo, then rE-4 5 mcg, then rE-4 10 mcg
arm group label: Placebo 5 mcg
arm group type: Placebo Comparator
description: Placebo 5 mcg, then Placebo 5 mcg, then Placebo 5 mcg
arm group label: Placebo 10 mcg
arm group type: Placebo Comparator
description: Placebo 5 mcg, then Placebo 5 mcg, then Placebo 10 mcg
intervention type: Biological
intervention name: rE-4 5 mcg
description: Placebo Lead In (5 mcg) for 4 weeks / rE-4 5 mcg for 4 weeks / rE-4 5 mcg for 26 weeks - All are subcutaneously injected twice daily
arm group label: rE-4 5 mcg
other name: rExenatide-4
intervention type: Biological
intervention name: rE-4 10 mcg
description: Placebo Lead In (5 mcg) for 4 weeks / rE-4 5 mcg for 4 weeks / rE-4 10 mcg for 26 weeks - All are subcutaneously injected twice daily
arm group label: rE-4 10 mcg
other name: rExenatide-4
intervention type: Biological
intervention name: Placebo 5 mcg
description: Placebo Lead In (5 mcg) for 4 weeks / Placebo 5 mcg for 4 weeks / Placebo 5 mcg for 26 weeks - All are subcutaneously injected twice daily
arm group label: Placebo 5 mcg
intervention type: Biological
intervention name: Placebo 10 mcg
description: Placebo Lead In (5 mcg) for 4 weeks / Placebo 5 mcg for 4 weeks / Placebo 10 mcg for 26 weeks - All are subcutaneously injected twice daily
arm group label: Placebo 10 mcg
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: linong Ji, Ph.D
role: Principal Investigator
affiliation: Peking University People's Hospital
last name: linong Ji, Ph.D
phone: +86-01088325578
email: jiln@bjmu.edu.cn
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No