<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/NCT04504396</url>
  </required_header>
  <id_info>
    <org_study_id>PB119302</org_study_id>
    <nct_id>NCT04504396</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of PB-119 in Subjects With Type 2 Diabetes and Not Well-controlled by Metformin Monotherapy</brief_title>
  <official_title>A Multicenter, Randomized, Double-blinded, Placebo-controlled Trial Comparing the Efficacy and Safety of PB-119 in Combination With Metformin in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Alone</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>PegBio Co., Ltd.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>PegBio 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 is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and&#xD;
      safety of 24 once-weekly subcutaneous doses of PB-119 to subjects with type 2 diabetes&#xD;
      mellitus (T2DM) not well-controlled by metformin monotherapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a phase 3 multicenter, randomized, double-blind, placebo-controlled, parallel dose&#xD;
      cohort study to evaluate the efficacy and safety of PB-119 to patients with T2DM not&#xD;
      well-controlled by metformin monotherapy. Patients will be assessed for eligibility over a 2&#xD;
      week screening period prior to a 4-week run-in period,a 24-week double-blind treatment period&#xD;
      and a 28-week open-label treatment period. The eligible patients will be randomized to PB-119&#xD;
      or placebo cohort at a 1:1 ratio for the first 24-week. Patients in PB-119 group will&#xD;
      subsequently be given active drug and patients in placebo group will take placebo, all&#xD;
      patients in two groups will remain metformin background therapy. In the 28-week open-label&#xD;
      period, all patients will be administered active drugs. After that, there will be a 4-week&#xD;
      follow-up period; All randomized patients will be taken blood samples for the pharmacokinetic&#xD;
      (PK) analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 23, 2020</start_date>
  <completion_date type="Actual">May 26, 2023</completion_date>
  <primary_completion_date type="Actual">September 15, 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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in HbA1c</measure>
    <time_frame>week 1, week 25</time_frame>
    <description>Change in HbA1c from baseline(week 1) to week 25</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>HbA1c Below 7.0%</measure>
    <time_frame>week 1, week 25</time_frame>
    <description>Percentage of participants with HbA1c below 7.0% was evaluated at week 25.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Body Weight (kg)</measure>
    <time_frame>week 1, week 25</time_frame>
    <description>Change from baseline (week 1) in body weight was evaluated at week 25</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fasting Plasma Glucose (FPG)</measure>
    <time_frame>week 1, week 25</time_frame>
    <description>Change from baseline (week 1) in FPG was evaluated at week 25</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Body Mass Index</measure>
    <time_frame>week 1, week 25</time_frame>
    <description>Change from baseline (week 1) in body mass index (BMI) was evaluated at week 25.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">620</enrollment>
  <condition>Type 2 Diabetes Mellitus (T2DM)</condition>
  <arm_group>
    <arm_group_label>PB-119 once-weekly-subcutaneous injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PB119 (polyethylene glycol exenatide) is a long-acting GLP-1RA for injection, which will be administered 150μg once-weekly subcutaneously to patients in active drug group for 24 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo once-weekly-subcutaneous injection</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>PB-119 150μg matched placebo which will be used in placebo group for 24 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GLP-1 receptor agonist</intervention_name>
    <description>PB-119 is an investigational pegylated human glucagon-like peptide-1 (GLP-1) receptor agonist. The dosing regimen is 150μg once every week as subcutaneous administration. Patients in PB-119 group will be administered the active drugs for 52 weeks (24+28).</description>
    <arm_group_label>PB-119 once-weekly-subcutaneous injection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>PB-119 matched placebo will be used once every week as subcutaneous administration to placebo group for 24 weeks.</description>
    <arm_group_label>Placebo once-weekly-subcutaneous injection</arm_group_label>
    <other_name>PB-119 Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female, aged 18~75 years old;&#xD;
&#xD;
          -  T2DM and treated with Metformin ≥ 1500mg/day or maximum tolerated&#xD;
             dose(≥1000mg,&lt;1500mg) constantly for at least 8 consecutive weeks;&#xD;
&#xD;
          -  7.5% ≤ HbA1c ≤ 10.0% at screening;&#xD;
&#xD;
          -  18.5 kg/m2 &lt; BMI &lt; 40.0 kg/m2 at screening;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any anti-diabetic therapy other than Metformin within 8 weeks before screening；&#xD;
&#xD;
          -  T1DM;&#xD;
&#xD;
          -  Received insulin therapy more than 14 days within 1 year before screening;&#xD;
&#xD;
          -  Female who is pregnant, breast-feeding;&#xD;
&#xD;
          -  Any disorder which in the investigator's opinion might jeopardise subject's safety or&#xD;
             compliance with the protocol;&#xD;
&#xD;
          -  History of acute diabetic complications, such as diabetic ketoacidosis or&#xD;
             hyperglycemic hyperosmolar status within 6 months before screening；&#xD;
&#xD;
          -  History or presence of pancreatitis (acute or chronic);&#xD;
&#xD;
          -  Presence or history of malignant neoplasms within the past 5 years prior to the day of&#xD;
             screening&#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>HuiMin Zhou, MD，PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>First Hospital of Hebei Medical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>WeiHong Song, MD，PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>First People's Hospital of Chenzhou</affiliation>
  </overall_official>
  <overall_official>
    <last_name>YanJun Wang, MD，PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Second Hospital of Jilin University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jing Yang, MD，PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The First Affiliated Hospital of Shanxi Medical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bin Gao, MD，PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tang-Du Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>XinLing Wang, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>People's Hospital of Xinjiang Uygur Autonomous Region</affiliation>
  </overall_official>
  <overall_official>
    <last_name>MingHui Hou, MD，PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Affiliated Hospital of Hebei University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lin Liao, MD，PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Qianfoshan Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Linong Ji, MD，PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing University People's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Minxiu Yao, MD，PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Qingdao Central Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Huige Shao, MD，PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Changsha Central Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jingna Lin, MD，PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tianjin People's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Xiaohong Lin, MD，PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>ZhuZhou Central Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jianhua Ma, MD，PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The First Affiliated Hospital with Nanjing Medical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Wei Zhang, MD，PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Qiqihar First Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hui Liu, MD，PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Luoyang Central Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tao Ning, MD，PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Baotou Central Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Xiaohong Wu, MD，PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zhejiang Province People's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Xueying Wang, MD，PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jingzhou Central Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lan Xu, MD，PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>WuXi Central Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beijing University People's Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>August 5, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>July 27, 2023</last_update_submitted>
  <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 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>
    <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/NCT04504396
org study id: PB119302
nct id: NCT04504396
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and
      safety of 24 once-weekly subcutaneous doses of PB-119 to subjects with type 2 diabetes
      mellitus (T2DM) not well-controlled by metformin monotherapy.
This is a phase 3 multicenter, randomized, double-blind, placebo-controlled, parallel dose
      cohort study to evaluate the efficacy and safety of PB-119 to patients with T2DM not
      well-controlled by metformin monotherapy. Patients will be assessed for eligibility over a 2
      week screening period prior to a 4-week run-in period,a 24-week double-blind treatment period
      and a 28-week open-label treatment period. The eligible patients will be randomized to PB-119
      or placebo cohort at a 1:1 ratio for the first 24-week. Patients in PB-119 group will
      subsequently be given active drug and patients in placebo group will take placebo, all
      patients in two groups will remain metformin background therapy. In the 28-week open-label
      period, all patients will be administered active drugs. After that, there will be a 4-week
      follow-up period; All randomized patients will be taken blood samples for the pharmacokinetic
      (PK) analysis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in HbA1c
time frame: week 1, week 25
description: Change in HbA1c from baseline(week 1) to week 25
measure: HbA1c Below 7.0%
time frame: week 1, week 25
description: Percentage of participants with HbA1c below 7.0% was evaluated at week 25.
measure: Change in Body Weight (kg)
time frame: week 1, week 25
description: Change from baseline (week 1) in body weight was evaluated at week 25
measure: Change in Fasting Plasma Glucose (FPG)
time frame: week 1, week 25
description: Change from baseline (week 1) in FPG was evaluated at week 25
measure: Change in Body Mass Index
time frame: week 1, week 25
description: Change from baseline (week 1) in body mass index (BMI) was evaluated at week 25.
arm group label: PB-119 once-weekly-subcutaneous injection
arm group type: Experimental
description: PB119 (polyethylene glycol exenatide) is a long-acting GLP-1RA for injection, which will be administered 150μg once-weekly subcutaneously to patients in active drug group for 24 weeks.
arm group label: Placebo once-weekly-subcutaneous injection
arm group type: Placebo Comparator
description: PB-119 150μg matched placebo which will be used in placebo group for 24 weeks.
intervention type: Drug
intervention name: GLP-1 receptor agonist
description: PB-119 is an investigational pegylated human glucagon-like peptide-1 (GLP-1) receptor agonist. The dosing regimen is 150μg once every week as subcutaneous administration. Patients in PB-119 group will be administered the active drugs for 52 weeks (24+28).
arm group label: PB-119 once-weekly-subcutaneous injection
intervention type: Drug
intervention name: Placebo
description: PB-119 matched placebo will be used once every week as subcutaneous administration to placebo group for 24 weeks.
arm group label: Placebo once-weekly-subcutaneous injection
other name: PB-119 Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: HuiMin Zhou, MD，PhD
role: Principal Investigator
affiliation: First Hospital of Hebei Medical University
last name: WeiHong Song, MD，PhD
role: Principal Investigator
affiliation: First People's Hospital of Chenzhou
last name: YanJun Wang, MD，PhD
role: Principal Investigator
affiliation: Second Hospital of Jilin University
last name: Jing Yang, MD，PhD
role: Principal Investigator
affiliation: The First Affiliated Hospital of Shanxi Medical University
last name: Bin Gao, MD，PhD
role: Principal Investigator
affiliation: Tang-Du Hospital
last name: XinLing Wang, Doctor
role: Principal Investigator
affiliation: People's Hospital of Xinjiang Uygur Autonomous Region
last name: MingHui Hou, MD，PhD
role: Principal Investigator
affiliation: Affiliated Hospital of Hebei University
last name: Lin Liao, MD，PhD
role: Principal Investigator
affiliation: Qianfoshan Hospital
last name: Linong Ji, MD，PhD
role: Principal Investigator
affiliation: Beijing University People's Hospital
last name: Minxiu Yao, MD，PhD
role: Principal Investigator
affiliation: Qingdao Central Hospital
last name: Huige Shao, MD，PhD
role: Principal Investigator
affiliation: Changsha Central Hospital
last name: Jingna Lin, MD，PhD
role: Principal Investigator
affiliation: Tianjin People's Hospital
last name: Xiaohong Lin, MD，PhD
role: Principal Investigator
affiliation: ZhuZhou Central Hospital
last name: Jianhua Ma, MD，PhD
role: Principal Investigator
affiliation: The First Affiliated Hospital with Nanjing Medical University
last name: Wei Zhang, MD，PhD
role: Principal Investigator
affiliation: Qiqihar First Hospital
last name: Hui Liu, MD，PhD
role: Principal Investigator
affiliation: Luoyang Central Hospital
last name: Tao Ning, MD，PhD
role: Principal Investigator
affiliation: Baotou Central Hospital
last name: Xiaohong Wu, MD，PhD
role: Principal Investigator
affiliation: Zhejiang Province People's Hospital
last name: Xueying Wang, MD，PhD
role: Principal Investigator
affiliation: Jingzhou Central Hospital
last name: Lan Xu, MD，PhD
role: Principal Investigator
affiliation: WuXi Central Hospital
facility: 
country: China
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No