<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/NCT04466904</url>
  </required_header>
  <id_info>
    <org_study_id>CIBI362A101</org_study_id>
    <nct_id>NCT04466904</nct_id>
  </id_info>
  <brief_title>Multiple-dose Tolerability and Pharmacokinetic of IBI362 in Chinese Patients With T2DM</brief_title>
  <official_title>A Multiple Dose Human Tolerability and Pharmacokinetic Study of IBI362 in Chinese Patients With Type 2 Diabetes Mellitus and Poor Glycemic Control</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Innovent Biologics (Suzhou) Co. Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Innovent Biologics (Suzhou) 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 trial is aimed to investigate the safety, tolerability, PK and PD of multiple&#xD;
      subcutaneous injections of IBI362 in Chinese patients with type 2 diabetes who have poor&#xD;
      glycemic control after lifestyle or metformin intervention&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multicenter, randomized, double-blind, placebo-controlled trial, the first trial to&#xD;
      assess the safety, tolerability, and PK/PD of IBI362 administered as multiple injections in&#xD;
      Chinese patients with type 2 diabetes. The investigators and subjects will be blinded to the&#xD;
      study drug IBI362 and placebo. Dulaglutide will be used as an open-label active control&#xD;
      group. In this trial, 42 eligible patients will be recruited and randomly allocated to three&#xD;
      cohorts. Each corhot will be randomized as an 8:4:2 ratio to IBI362 (n = 8), placebo (n = 4),&#xD;
      and Dulaglutide 1.5 mg (n = 2).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 12, 2020</start_date>
  <completion_date type="Actual">May 28, 2021</completion_date>
  <primary_completion_date type="Actual">May 28, 2021</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To assess the number and incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of IBI362 compared with placebo</measure>
    <time_frame>From the first dose of study drug to week 19</time_frame>
    <description>Number of subjects with treatment emergent adverse events and serious adverse events through the end of the follow-up period</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The PK/PD parameters of IBI362 in patients with T2DM</measure>
    <time_frame>From Baseline to week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the Peak Plasma Concentration (Cmax) of IBI362 in patients with T2DM</measure>
    <time_frame>From Baseline to week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the Area under the plasma concentration versus time curve (AUC) of IBI362 in patients with T2DM</measure>
    <time_frame>From Baseline to week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the Fasting Blood Glucose (FBG ) of IBI362 in patients with T2DM</measure>
    <time_frame>From Baseline to week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the Glucagon of IBI362 in patients with T2DM</measure>
    <time_frame>From Baseline to week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the Insulin of IBI362 in patients with T2DM</measure>
    <time_frame>From Baseline to week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the C-peptide of IBI362 in patients with T2DM</measure>
    <time_frame>From Baseline to week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Anti-IBI362 Antibodies</measure>
    <time_frame>From the first dose of study drug to week 19</time_frame>
    <description>Serum samples will be analyzed by an electrochemiluminescence (ECL)-based immunoassay for anti-IBI362 binding antibodies. Positive samples will be subsequently tested in a receptor-ligand binding bioassay for anti-IBI362 neutralizing antibodies.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Type 2 Diabetes</condition>
  <arm_group>
    <arm_group_label>IBI362 low dose cohort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive low dose level of IBI362, matched placebo or Dulaglutide administrated by multiple subcutaneous injection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IBI362 medium dose cohort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive medium dose level of IBI362, matched placebo or Dulaglutide administrated by multiple subcutaneous injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IBI362 high dose cohort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive high dose level of IBI362, matched placebo or Dulaglutide administrated by multiple subcutaneous injection</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IBI362</intervention_name>
    <description>Administrated by subcutaneous injection</description>
    <arm_group_label>IBI362 high dose cohort</arm_group_label>
    <arm_group_label>IBI362 low dose cohort</arm_group_label>
    <arm_group_label>IBI362 medium dose cohort</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Administrated by subcutaneous injection</description>
    <arm_group_label>IBI362 high dose cohort</arm_group_label>
    <arm_group_label>IBI362 low dose cohort</arm_group_label>
    <arm_group_label>IBI362 medium dose cohort</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dulaglutide</intervention_name>
    <description>Administrated by subcutaneous injection</description>
    <arm_group_label>IBI362 high dose cohort</arm_group_label>
    <arm_group_label>IBI362 low dose cohort</arm_group_label>
    <arm_group_label>IBI362 medium dose cohort</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        * Eligibility Criteria： Inclusion Criiteria:&#xD;
&#xD;
          1. Male or female 18 to 75 years of age at the time of consent.&#xD;
&#xD;
          2. T2D patients with poorly controlled blood glucose treated with lifestyle intervention&#xD;
             or stable dose of metformin (≥ 1000mg/day or maximum tolerated dose) within 2 months&#xD;
             prior to screening.&#xD;
&#xD;
          3. HbA1c 7.5% ≤ 11.0% by local laboratory at screening.&#xD;
&#xD;
          4. Body mass index 20 ≤ BMI ≤ 35 kg/m2.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Type 1 diabetes, special types of diabetes, or gestational diabetes.&#xD;
&#xD;
          2. Ketoacidosis or lactic acidosis within 6 months prior to screening.&#xD;
&#xD;
          3. History of severe hypoglycaemic episodes within 6 months prior to screening.&#xD;
&#xD;
          4. Acute myocardial infarction, unstable angina pectoris, coronary artery bypass&#xD;
             grafting, coronary intervention (except diagnostic angiography), transient ischemic&#xD;
             attack (TIA), cerebrovascular accident, acute and chronic heart failure within 6&#xD;
             months before screening.&#xD;
&#xD;
          5. Clinically symptomatic liver disease, acute or chronic hepatitis, or transaminases&#xD;
             (ALT and AST) and alkaline phosphatase (ALP) &gt; 2 times the upper limit of normal and&#xD;
             total bilirubin above the upper limit of normal at screening.&#xD;
&#xD;
          6. The patient was previously diagnosed with autonomic neuropathy, manifested as urinary&#xD;
             retention, resting tachycardia, orthostatic hypotension and diabetic diarrhea.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>China Japan Friendship Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>July 21, 2021</last_update_submitted>
  <last_update_submitted_qc>July 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2021</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, Type 2</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dulaglutide</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/NCT04466904
org study id: CIBI362A101
nct id: NCT04466904
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This trial is aimed to investigate the safety, tolerability, PK and PD of multiple
      subcutaneous injections of IBI362 in Chinese patients with type 2 diabetes who have poor
      glycemic control after lifestyle or metformin intervention
This is a multicenter, randomized, double-blind, placebo-controlled trial, the first trial to
      assess the safety, tolerability, and PK/PD of IBI362 administered as multiple injections in
      Chinese patients with type 2 diabetes. The investigators and subjects will be blinded to the
      study drug IBI362 and placebo. Dulaglutide will be used as an open-label active control
      group. In this trial, 42 eligible patients will be recruited and randomly allocated to three
      cohorts. Each corhot will be randomized as an 8:4:2 ratio to IBI362 (n = 8), placebo (n = 4),
      and Dulaglutide 1.5 mg (n = 2).
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: To assess the number and incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of IBI362 compared with placebo
time frame: From the first dose of study drug to week 19
description: Number of subjects with treatment emergent adverse events and serious adverse events through the end of the follow-up period
measure: The PK/PD parameters of IBI362 in patients with T2DM
time frame: From Baseline to week 12
measure: Evaluate the Peak Plasma Concentration (Cmax) of IBI362 in patients with T2DM
time frame: From Baseline to week 12
measure: Evaluate the Area under the plasma concentration versus time curve (AUC) of IBI362 in patients with T2DM
time frame: From Baseline to week 12
measure: Evaluate the Fasting Blood Glucose (FBG ) of IBI362 in patients with T2DM
time frame: From Baseline to week 12
measure: Evaluate the Glucagon of IBI362 in patients with T2DM
time frame: From Baseline to week 12
measure: Evaluate the Insulin of IBI362 in patients with T2DM
time frame: From Baseline to week 12
measure: Evaluate the C-peptide of IBI362 in patients with T2DM
time frame: From Baseline to week 12
measure: Number of Participants With Anti-IBI362 Antibodies
time frame: From the first dose of study drug to week 19
description: Serum samples will be analyzed by an electrochemiluminescence (ECL)-based immunoassay for anti-IBI362 binding antibodies. Positive samples will be subsequently tested in a receptor-ligand binding bioassay for anti-IBI362 neutralizing antibodies.
arm group label: IBI362 low dose cohort
arm group type: Experimental
description: Participants receive low dose level of IBI362, matched placebo or Dulaglutide administrated by multiple subcutaneous injection.
arm group label: IBI362 medium dose cohort
arm group type: Experimental
description: Participants receive medium dose level of IBI362, matched placebo or Dulaglutide administrated by multiple subcutaneous injection
arm group label: IBI362 high dose cohort
arm group type: Experimental
description: Participants receive high dose level of IBI362, matched placebo or Dulaglutide administrated by multiple subcutaneous injection
intervention type: Drug
intervention name: IBI362
description: Administrated by subcutaneous injection
arm group label: IBI362 high dose cohort
arm group label: IBI362 low dose cohort
arm group label: IBI362 medium dose cohort
intervention type: Drug
intervention name: Placebo
description: Administrated by subcutaneous injection
arm group label: IBI362 high dose cohort
arm group label: IBI362 low dose cohort
arm group label: IBI362 medium dose cohort
intervention type: Drug
intervention name: Dulaglutide
description: Administrated by subcutaneous injection
arm group label: IBI362 high dose cohort
arm group label: IBI362 low dose cohort
arm group label: IBI362 medium dose cohort
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 2
mesh term: Dulaglutide