<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/NCT01667900</url>
  </required_header>
  <id_info>
    <org_study_id>12925</org_study_id>
    <secondary_id>H9X-EW-GBDL</secondary_id>
    <nct_id>NCT01667900</nct_id>
  </id_info>
  <brief_title>A Study of Dulaglutide in Chinese Participants</brief_title>
  <official_title>Pharmacokinetics of a Single Dulaglutide Dose in Healthy Chinese Subjects and of Multiple Dulaglutide Doses in Chinese Patients With T2DM</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eli Lilly and Company</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a study of dulaglutide in Chinese participants. The purpose of the study is to&#xD;
      determine how the body processes dulaglutide and how dulaglutide affects the body. This study&#xD;
      has 2 parts: Part A - single dose of dulaglutide administered to healthy participants in 2 of&#xD;
      3 study periods. There is a minimum 28-day washout between periods. Part A will last&#xD;
      approximately 16 weeks. Part B - multiple doses of dulaglutide administered to participants&#xD;
      with Type 2 diabetes mellitus (T2DM). Part B will last approximately 15 weeks.&#xD;
&#xD;
      Doses of 0.5 milligrams (mg), 0.75 mg, and 1.5 mg of dulaglutide will be evaluated in this&#xD;
      study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</primary_completion_date>
  <phase>Phase 1</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>Pharmacokinetics: Maximum Concentration (Cmax) of Dulaglutide</measure>
    <time_frame>Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose</time_frame>
    <description>Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics: Time of Maximum Observed Concentration (Tmax) of Dulaglutide</measure>
    <time_frame>Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose</time_frame>
    <description>Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics: Area Under the Concentration-time Curve From Time Zero to 336 Hours Postdose (AUC[0-336]) of Dulaglutide</measure>
    <time_frame>Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose</time_frame>
    <description>Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics: Half-life of Dulaglutide</measure>
    <time_frame>Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose</time_frame>
    <description>Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Part B - Pharmacodynamics: Area Under the Plasma Glucose Time Curve From Time Zero to 4 Hours Postmeal (gAUC[0-4])</measure>
    <time_frame>Baseline and Days 3, 24, and 29</time_frame>
    <description>Pharmacodynamic parameters were assessed at baseline and on Days 3, 24, and 29 in Part B.</description>
  </secondary_outcome>
  <number_of_arms>8</number_of_arms>
  <enrollment type="Actual">58</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>0.5 mg Dulaglutide (Part A-Healthy)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>0.5 milligrams (mg) dulaglutide administered once subcutaneously (SQ) to healthy participants in 1 of 3 treatment periods</description>
  </arm_group>
  <arm_group>
    <arm_group_label>0.75 mg Dulaglutide (Part A-Healthy)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>0.75 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods</description>
  </arm_group>
  <arm_group>
    <arm_group_label>1.5 mg Dulaglutide (Part A-Healthy)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo (Part A-Healthy)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo administered once SQ to healthy participants in 1 of 3 treatment periods</description>
  </arm_group>
  <arm_group>
    <arm_group_label>0.5 mg Dulaglutide (Part B-T2DM)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>0.5 mg dulaglutide administered to participants with Type 2 diabetes mellitus (T2DM) once weekly SQ for 4 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>0.75 mg Dulaglutide (Part B-T2DM)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>1.5 mg Dulaglutide (Part B-T2DM)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo (Part B-T2DM)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo administered to participants with T2DM once weekly SQ for 4 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dulaglutide</intervention_name>
    <arm_group_label>0.5 mg Dulaglutide (Part A-Healthy)</arm_group_label>
    <arm_group_label>0.5 mg Dulaglutide (Part B-T2DM)</arm_group_label>
    <arm_group_label>0.75 mg Dulaglutide (Part A-Healthy)</arm_group_label>
    <arm_group_label>0.75 mg Dulaglutide (Part B-T2DM)</arm_group_label>
    <arm_group_label>1.5 mg Dulaglutide (Part A-Healthy)</arm_group_label>
    <arm_group_label>1.5 mg Dulaglutide (Part B-T2DM)</arm_group_label>
    <other_name>LY2189265</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms.</description>
    <arm_group_label>0.5 mg Dulaglutide (Part A-Healthy)</arm_group_label>
    <arm_group_label>0.5 mg Dulaglutide (Part B-T2DM)</arm_group_label>
    <arm_group_label>0.75 mg Dulaglutide (Part A-Healthy)</arm_group_label>
    <arm_group_label>0.75 mg Dulaglutide (Part B-T2DM)</arm_group_label>
    <arm_group_label>1.5 mg Dulaglutide (Part A-Healthy)</arm_group_label>
    <arm_group_label>1.5 mg Dulaglutide (Part B-T2DM)</arm_group_label>
    <arm_group_label>Placebo (Part A-Healthy)</arm_group_label>
    <arm_group_label>Placebo (Part B-T2DM)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All Participants:&#xD;
&#xD;
          -  Native Chinese (all 4 grandparents of Chinese origin)&#xD;
&#xD;
          -  Male participants with female partners of child-bearing potential, or partners who are&#xD;
             pregnant or breastfeeding, agree to use a reliable method of contraception from the&#xD;
             time of the first dose until 3 months after the last dose of investigational product,&#xD;
             as determined by the investigator.&#xD;
&#xD;
          -  The method of contraception may be one of the following: condom with spermicidal&#xD;
             agent, male participant sterilization, true abstinence (which is in line with the&#xD;
             participant's usual lifestyle choice; withdrawal or calendar methods are not&#xD;
             considered acceptable).&#xD;
&#xD;
          -  Female participants not of child-bearing potential (i.e. are postmenopausal or&#xD;
             permanently sterilized [e.g. tubal occlusion, hysterectomy, bilateral salpingectomy]).&#xD;
             Such participants will not be required to use contraception but must test negative for&#xD;
             pregnancy at the time of enrollment. Postmenopausal is defined as at least 1 year post&#xD;
             cessation of menses (without an alternative medical cause) or at least 1 year of&#xD;
             spontaneous amenorrhea, with follicle stimulating hormone (FSH) ≥40 milli&#xD;
             international units per milliliter (mIU/mL).&#xD;
&#xD;
          -  Female participants who have undergone sterilization by tubal ligation: agree to use a&#xD;
             condom in conjunction with spermicidal gel, foam, cream, film or suppository from the&#xD;
             time of screening until 3 months after the last dose of investigational product. Such&#xD;
             participants must also test negative for pregnancy at the time of enrollment.&#xD;
&#xD;
        Participants with T2DM:&#xD;
&#xD;
          -  Have T2DM controlled with diet or exercise alone or with a single oral agent&#xD;
             antihyperglycemic medication (OAM) (metformin, sulfonylureas, meglitinides, acarbose&#xD;
             [or other disaccharidase inhibitors] or thiazolidinediones) for at least 3 weeks (3&#xD;
             months for thiazolidinediones) before admission. Note that participants receiving&#xD;
             sulfonylureas, meglitinides or acarbose may participate only if this treatment is&#xD;
             stopped and metformin substituted. If switched to metformin, participants should be&#xD;
             allowed to stabilize on metformin for 3 weeks before receiving study drug.&#xD;
&#xD;
          -  If T2DM controlled with diet or exercise alone, must have a hemoglobin A1c (HbA1c)&#xD;
             value of 6.5% to 10.5% at screening and a fasting blood glucose value of 126 to 250&#xD;
             milligrams per deciliter (mg/dL) (approximately 7.0 to 13.9 millimoles per liter&#xD;
             [mmol/L]) at screening.&#xD;
&#xD;
          -  If T2DM controlled with OAM(s), must have an HbA1c value of 9.0% or less at screening&#xD;
             and a fasting blood glucose value of 110 to 200 mg/dL (approximately 6.1 to 11.1&#xD;
             mmol/L) at screening. If a participant's T2DM is being controlled with OAM(s) other&#xD;
             than metformin, the participant's OAM will be stopped for at least 3 weeks before&#xD;
             administration of study drug.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        All Participants:&#xD;
&#xD;
          -  Have a history or presence of cardiovascular (myocardial infarction, cerebrovascular&#xD;
             accident, venous thromboembolism), respiratory, hepatic, renal, hematological,&#xD;
             neurological autoimmune or endocrine (except T2DM), disorders capable of significantly&#xD;
             altering the absorption, metabolism, or elimination of drugs; of constituting a risk&#xD;
             when taking the study medication; or of interfering with the interpretation of data.&#xD;
&#xD;
          -  Have evidence of significant active neuropsychiatric disease.&#xD;
&#xD;
          -  Have poorly controlled hypertension (systolic &gt;160 millimeters of mercury [mmHg]&#xD;
             and/or diastolic &gt;100 mmHg) and/or evidence of labile blood pressure including&#xD;
             symptomatic postural hypotension.&#xD;
&#xD;
          -  Have a history or presence of pancreatitis (history of chronic pancreatitis or&#xD;
             idiopathic acute pancreatitis) or gastrointestinal disorder, for example relevant&#xD;
             esophageal reflux or gall bladder disease, or any gastrointestinal disease which&#xD;
             impacts gastric empty (for example, gastric bypass surgery, pyloric stenosis, with the&#xD;
             exception of appendectomy) or could be aggravated by glucagon-like peptide-1 (GLP-1)&#xD;
             analogs or dipeptidyl peptidase (DPP)-4 inhibitors. Participants with dyslipidemia,&#xD;
             and participants who had cholecystolithiasis (removal of gall stones) and/or&#xD;
             cholecystectomy (removal of gall bladder) in the past, with no further sequelae, may&#xD;
             be included in the study at the discretion of the screening physician.&#xD;
&#xD;
          -  Have personal or family history of medullary thyroid cancer (MTC) or a genetic&#xD;
             condition that predisposes to MTC.&#xD;
&#xD;
        Participants with T2DM&#xD;
&#xD;
          -  Have experienced outpatient use of insulin for control of diabetes within the past 6&#xD;
             months.&#xD;
&#xD;
          -  Have clinically significant peripheral vascular occlusive disease in the opinion of&#xD;
             the investigator.&#xD;
&#xD;
          -  Have known severe exudative diabetic retinopathy in the opinion of the investigator.&#xD;
&#xD;
          -  Have known significant autonomic neuropathy as evidenced by urinary retention,&#xD;
             diabetic diarrhea, or gastroparesis.&#xD;
&#xD;
          -  Have experienced a ketoacidotic episode (pH less than 7.3) requiring hospitalization&#xD;
             in the last 6 months.&#xD;
&#xD;
          -  Regular use of drugs that affect the glycodynamics and that directly reduce&#xD;
             gastrointestinal motility (eg, anticholinergics, antispasmodics, 5HT3 antagonists,&#xD;
             dopamine antagonists, and opiates) and of systemic corticosteroids by oral,&#xD;
             intravenous, or intramuscular route, or potent, inhaled, or intranasal steroids known&#xD;
             to have a high rate of systemic absorption.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM- 5 PM Eastern time (UTC/GMT -5 hours, EST)</last_name>
    <role>Study Director</role>
    <affiliation>Eli Lilly and Company</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Beijing</city>
        <zip>100034</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>August 15, 2012</study_first_submitted>
  <study_first_submitted_qc>August 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 2012</study_first_posted>
  <results_first_submitted>June 9, 2015</results_first_submitted>
  <results_first_submitted_qc>February 8, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">March 7, 2016</results_first_posted>
  <last_update_submitted>February 8, 2016</last_update_submitted>
  <last_update_submitted_qc>February 8, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 7, 2016</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>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>First 0.5 mg, Then Placebo, Then 1.5 mg (Part A-Healthy)</title>
          <description>Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.&#xD;
Period 1: 0.5 milligrams (mg) dulaglutide administered once subcutaneously (SQ)&#xD;
Period 2: placebo administered once SQ&#xD;
Period 3: 1.5 mg dulaglutide administered once SQ</description>
        </group>
        <group group_id="P2">
          <title>First 0.75 mg, Then 0.5 mg, Then Placebo (Part A-Healthy)</title>
          <description>Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.&#xD;
Period 1: 0.75 mg dulaglutide administered once SQ&#xD;
Period 2: 0.5 mg dulaglutide administered once SQ&#xD;
Period 3: placebo administered once SQ</description>
        </group>
        <group group_id="P3">
          <title>First 0.75 mg, Then 1.5 mg, Then Placebo (Part A-Healthy)</title>
          <description>Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.&#xD;
Period 1: 0.75 mg dulaglutide administered once SQ&#xD;
Period 2: 1.5 mg dulaglutide administered once SQ&#xD;
Period 3: placebo administered once SQ</description>
        </group>
        <group group_id="P4">
          <title>First 0.5 mg, Then 1.5 mg, Then Placebo (Part A-Healthy)</title>
          <description>Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.&#xD;
Period 1: 0.5 mg dulaglutide administered once SQ&#xD;
Period 2: 1.5 mg dulaglutide administered once SQ&#xD;
Period 3: placebo administered once SQ</description>
        </group>
        <group group_id="P5">
          <title>First 1.5 mg, Then Placebo, Then 0.75 mg (Part A-Healthy)</title>
          <description>Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.&#xD;
Period 1: 1.5 mg dulaglutide administered once SQ&#xD;
Period 2: placebo administered once SQ&#xD;
Period 3: 0.75 mg dulaglutide administered once SQ</description>
        </group>
        <group group_id="P6">
          <title>First Placebo, Then 0.5 mg, Then 1.5 mg (Part A-Healthy)</title>
          <description>Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.&#xD;
Period 1: placebo administered once SQ&#xD;
Period 2: 0.5 mg dulaglutide administered once SQ&#xD;
Period 3: 1.5 mg dulaglutide administered once SQ</description>
        </group>
        <group group_id="P7">
          <title>First 0.75 mg, Then Placebo, Then 1.5 mg (Part A-Healthy)</title>
          <description>Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.&#xD;
Period 1: 0.75 mg dulaglutide administered once SQ&#xD;
Period 2: placebo administered once SQ&#xD;
Period 3: 1.5 mg dulaglutide administered once SQ</description>
        </group>
        <group group_id="P8">
          <title>First Placebo, Then 0.75 mg, Then 0.5 mg (Part A-Healthy)</title>
          <description>Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.&#xD;
Period 1: placebo administered once SQ&#xD;
Period 2: 0.75 mg dulaglutide administered once SQ&#xD;
Period 3: 0.5 mg dulaglutide administered once SQ</description>
        </group>
        <group group_id="P9">
          <title>First Placebo, Then 0.75 mg, Then 1.5 mg (Part A-Healthy)</title>
          <description>Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.&#xD;
Period 1: placebo administered once SQ&#xD;
Period 2: 0.75 mg dulaglutide administered once SQ&#xD;
Period 3: 1.5 mg dulaglutide administered once SQ</description>
        </group>
        <group group_id="P10">
          <title>First 0.5 mg, Then 0.75 mg, Then Placebo (Part A-Helathy)</title>
          <description>Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.&#xD;
Period 1: 0.5 mg dulaglutide administered once SQ&#xD;
Period 2: 0.75 mg dulaglutide administered once SQ&#xD;
Period 3: placebo administered once SQ</description>
        </group>
        <group group_id="P11">
          <title>First 1.5 mg, Then 0.75 mg, Then Placebo (Part A-Healthy)</title>
          <description>Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.&#xD;
Period 1: 1.5 mg dulaglutide administered once SQ&#xD;
Period 2: 0.75 mg dulaglutide administered once SQ&#xD;
Period 3: placebo administered once SQ</description>
        </group>
        <group group_id="P12">
          <title>First 0.5 mg, Then Placebo, Then 0.75 mg (Part A-Healthy)</title>
          <description>Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.&#xD;
Period 1: 0.5 mg dulaglutide administered once SQ&#xD;
Period 2: placebo administered once SQ&#xD;
Period 3: 0.75 mg dulaglutide administered once SQ</description>
        </group>
        <group group_id="P13">
          <title>First 0.75 mg, Then Placebo, Then 0.5 mg (Part A-Healthy)</title>
          <description>Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.&#xD;
Period 1: 0.75 mg dulaglutide administered once SQ&#xD;
Period 2: placebo administered once SQ&#xD;
Period 3: 0.5 mg dulaglutide administered once SQ</description>
        </group>
        <group group_id="P14">
          <title>First Placebo, Then 1.5 mg, Then 0.75 mg (Part A-Healthy)</title>
          <description>Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.&#xD;
Period 1: placebo administered once SQ&#xD;
Period 2: 1.5 mg dulaglutide administered once SQ&#xD;
Period 3: 0.75 mg dulaglutide administered once SQ</description>
        </group>
        <group group_id="P15">
          <title>First 1.5 mg, Then 0.5 mg, Then Placebo (Part A-Healthy)</title>
          <description>Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.&#xD;
Period 1: 1.5 mg dulaglutide administered once SQ&#xD;
Period 2: 0.5 mg dulaglutide administered once SQ&#xD;
Period 3: placebo administered once SQ</description>
        </group>
        <group group_id="P16">
          <title>First Placebo, Then 1.5 mg, Then 0.5 mg (Part A-Healthy)</title>
          <description>Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.&#xD;
Period 1: placebo administered once SQ&#xD;
Period 2: 1.5 mg dulaglutide administered once SQ&#xD;
Period 3: 0.5 mg dulaglutide administered once SQ</description>
        </group>
        <group group_id="P17">
          <title>0.5 mg Dulaglutide (Part B-T2DM)</title>
          <description>0.5 mg dulaglutide administered to participants with Type 2 diabetes mellitus (T2DM) once weekly SQ for 4 weeks in Part B</description>
        </group>
        <group group_id="P18">
          <title>0.75 mg Dulaglutide (Part B-T2DM)</title>
          <description>0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B</description>
        </group>
        <group group_id="P19">
          <title>1.5 mg Dulaglutide (Part B-T2DM)</title>
          <description>1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B</description>
        </group>
        <group group_id="P20">
          <title>Placebo (Part B-T2DM)</title>
          <description>Placebo administered to participants with T2DM once weekly SQ for 4 weeks in Part B</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Part A, Period 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="1"/>
                <participants group_id="P11" count="1"/>
                <participants group_id="P12" count="1"/>
                <participants group_id="P13" count="1"/>
                <participants group_id="P14" count="1"/>
                <participants group_id="P15" count="1"/>
                <participants group_id="P16" count="1"/>
                <participants group_id="P17" count="0">Part B participants did not participate in Part A.</participants>
                <participants group_id="P18" count="0">Part B participants did not participate in Part A.</participants>
                <participants group_id="P19" count="0">Part B participants did not participate in Part A.</participants>
                <participants group_id="P20" count="0">Part B participants did not participate in Part A.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="1"/>
                <participants group_id="P11" count="1"/>
                <participants group_id="P12" count="1"/>
                <participants group_id="P13" count="1"/>
                <participants group_id="P14" count="1"/>
                <participants group_id="P15" count="1"/>
                <participants group_id="P16" count="1"/>
                <participants group_id="P17" count="0"/>
                <participants group_id="P18" count="0"/>
                <participants group_id="P19" count="0"/>
                <participants group_id="P20" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
                <participants group_id="P18" count="0"/>
                <participants group_id="P19" count="0"/>
                <participants group_id="P20" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Part A, Washout 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="1"/>
                <participants group_id="P11" count="1"/>
                <participants group_id="P12" count="1"/>
                <participants group_id="P13" count="1"/>
                <participants group_id="P14" count="1"/>
                <participants group_id="P15" count="1"/>
                <participants group_id="P16" count="1"/>
                <participants group_id="P17" count="0"/>
                <participants group_id="P18" count="0"/>
                <participants group_id="P19" count="0"/>
                <participants group_id="P20" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="1"/>
                <participants group_id="P11" count="1"/>
                <participants group_id="P12" count="1"/>
                <participants group_id="P13" count="1"/>
                <participants group_id="P14" count="1"/>
                <participants group_id="P15" count="1"/>
                <participants group_id="P16" count="1"/>
                <participants group_id="P17" count="0"/>
                <participants group_id="P18" count="0"/>
                <participants group_id="P19" count="0"/>
                <participants group_id="P20" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
                <participants group_id="P18" count="0"/>
                <participants group_id="P19" count="0"/>
                <participants group_id="P20" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Part A, Period 2</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="1"/>
                <participants group_id="P11" count="1"/>
                <participants group_id="P12" count="1"/>
                <participants group_id="P13" count="1"/>
                <participants group_id="P14" count="1"/>
                <participants group_id="P15" count="1"/>
                <participants group_id="P16" count="1"/>
                <participants group_id="P17" count="0"/>
                <participants group_id="P18" count="0"/>
                <participants group_id="P19" count="0"/>
                <participants group_id="P20" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="1"/>
                <participants group_id="P11" count="1"/>
                <participants group_id="P12" count="1"/>
                <participants group_id="P13" count="1"/>
                <participants group_id="P14" count="1"/>
                <participants group_id="P15" count="1"/>
                <participants group_id="P16" count="1"/>
                <participants group_id="P17" count="0"/>
                <participants group_id="P18" count="0"/>
                <participants group_id="P19" count="0"/>
                <participants group_id="P20" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
                <participants group_id="P18" count="0"/>
                <participants group_id="P19" count="0"/>
                <participants group_id="P20" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Part A, Washout 2</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="1"/>
                <participants group_id="P11" count="1"/>
                <participants group_id="P12" count="1"/>
                <participants group_id="P13" count="1"/>
                <participants group_id="P14" count="1"/>
                <participants group_id="P15" count="1"/>
                <participants group_id="P16" count="1"/>
                <participants group_id="P17" count="0"/>
                <participants group_id="P18" count="0"/>
                <participants group_id="P19" count="0"/>
                <participants group_id="P20" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="1"/>
                <participants group_id="P11" count="1"/>
                <participants group_id="P12" count="1"/>
                <participants group_id="P13" count="1"/>
                <participants group_id="P14" count="1"/>
                <participants group_id="P15" count="1"/>
                <participants group_id="P16" count="1"/>
                <participants group_id="P17" count="0"/>
                <participants group_id="P18" count="0"/>
                <participants group_id="P19" count="0"/>
                <participants group_id="P20" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
                <participants group_id="P18" count="0"/>
                <participants group_id="P19" count="0"/>
                <participants group_id="P20" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Part A, Period 3</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="1"/>
                <participants group_id="P11" count="1"/>
                <participants group_id="P12" count="1"/>
                <participants group_id="P13" count="1"/>
                <participants group_id="P14" count="1"/>
                <participants group_id="P15" count="1"/>
                <participants group_id="P16" count="1"/>
                <participants group_id="P17" count="0"/>
                <participants group_id="P18" count="0"/>
                <participants group_id="P19" count="0"/>
                <participants group_id="P20" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="1"/>
                <participants group_id="P11" count="1"/>
                <participants group_id="P12" count="1"/>
                <participants group_id="P13" count="1"/>
                <participants group_id="P14" count="1"/>
                <participants group_id="P15" count="1"/>
                <participants group_id="P16" count="1"/>
                <participants group_id="P17" count="0"/>
                <participants group_id="P18" count="0"/>
                <participants group_id="P19" count="0"/>
                <participants group_id="P20" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
                <participants group_id="P18" count="0"/>
                <participants group_id="P19" count="0"/>
                <participants group_id="P20" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Part B</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0">Part A participants did not participate in Part B.</participants>
                <participants group_id="P2" count="0">Part A participants did not participate in Part B.</participants>
                <participants group_id="P3" count="0">Part A participants did not participate in Part B.</participants>
                <participants group_id="P4" count="0">Part A participants did not participate in Part B.</participants>
                <participants group_id="P5" count="0">Part A participants did not participate in Part B.</participants>
                <participants group_id="P6" count="0">Part A participants did not participate in Part B.</participants>
                <participants group_id="P7" count="0">Part A participants did not participate in Part B.</participants>
                <participants group_id="P8" count="0">Part A participants did not participate in Part B.</participants>
                <participants group_id="P9" count="0">Part A participants did not participate in Part B.</participants>
                <participants group_id="P10" count="0">Part A participants did not participate in Part B.</participants>
                <participants group_id="P11" count="0">Part A participants did not participate in Part B.</participants>
                <participants group_id="P12" count="0">Part A participants did not participate in Part B.</participants>
                <participants group_id="P13" count="0">Part A participants did not participate in Part B.</participants>
                <participants group_id="P14" count="0">Part A participants did not participate in Part B.</participants>
                <participants group_id="P15" count="0">Part A participants did not participate in Part B.</participants>
                <participants group_id="P16" count="0">Part A participants did not participate in Part B.</participants>
                <participants group_id="P17" count="11"/>
                <participants group_id="P18" count="11"/>
                <participants group_id="P19" count="10"/>
                <participants group_id="P20" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="10"/>
                <participants group_id="P18" count="11"/>
                <participants group_id="P19" count="10"/>
                <participants group_id="P20" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="1"/>
                <participants group_id="P18" count="0"/>
                <participants group_id="P19" count="0"/>
                <participants group_id="P20" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="1"/>
                <participants group_id="P18" count="0"/>
                <participants group_id="P19" count="0"/>
                <participants group_id="P20" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All enrolled participants.</population>
      <group_list>
        <group group_id="B1">
          <title>Part A-Healthy</title>
          <description>Part A (single-dose, 3 treatment period, crossover design) involved overtly healthy participants only. Each participant received single doses of placebo and 2 of the 3 dulaglutide doses (0.5, 0.75, and 1.5 mg), in 3 treatment periods, such that placebo was administered SQ to all 16 participants and 0.5, 0.75, and 1.5 mg dulaglutide was administered SQ to 10, 11, and 11 participants, respectively. There was a washout period of at least 28 days between doses.</description>
        </group>
        <group group_id="B2">
          <title>0.5 mg Dulaglutide (Part B-T2DM)</title>
          <description>0.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B</description>
        </group>
        <group group_id="B3">
          <title>0.75 mg Dulaglutide (Part B-T2DM)</title>
          <description>0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B</description>
        </group>
        <group group_id="B4">
          <title>1.5 mg Dulaglutide (Part B-T2DM)</title>
          <description>1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B</description>
        </group>
        <group group_id="B5">
          <title>Placebo (Part B-T2DM)</title>
          <description>Placebo administered to participants with T2DM once weekly SQ for 4 weeks in Part B</description>
        </group>
        <group group_id="B6">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="16"/>
            <count group_id="B2" value="11"/>
            <count group_id="B3" value="11"/>
            <count group_id="B4" value="10"/>
            <count group_id="B5" value="10"/>
            <count group_id="B6" value="58"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29.2" spread="5.6"/>
                    <measurement group_id="B2" value="58.2" spread="4.2"/>
                    <measurement group_id="B3" value="56.9" spread="13.1"/>
                    <measurement group_id="B4" value="55.8" spread="8.5"/>
                    <measurement group_id="B5" value="51.8" spread="8.3"/>
                    <measurement group_id="B6" value="48.4" spread="14.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="7"/>
                    <measurement group_id="B6" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="10"/>
                    <measurement group_id="B6" value="58"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="10"/>
                    <measurement group_id="B6" value="58"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>China</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="10"/>
                    <measurement group_id="B6" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetics: Maximum Concentration (Cmax) of Dulaglutide</title>
        <description>Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B.</description>
        <time_frame>Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose</time_frame>
        <population>Participants in Part A and Part B who received at least 1 dose of study drug and had evaluable Cmax data.</population>
        <group_list>
          <group group_id="O1">
            <title>0.5 mg Dulaglutide (Part A-Healthy)</title>
            <description>0.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A</description>
          </group>
          <group group_id="O2">
            <title>0.75 mg Dulaglutide (Part A-Healthy)</title>
            <description>0.75 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A</description>
          </group>
          <group group_id="O3">
            <title>1.5 mg Dulaglutide (Part A-Healthy)</title>
            <description>1.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A</description>
          </group>
          <group group_id="O4">
            <title>0.5 mg Dulaglutide (Part B-T2DM)</title>
            <description>0.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B</description>
          </group>
          <group group_id="O5">
            <title>0.75 mg Dulaglutide (Part B-T2DM)</title>
            <description>0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B</description>
          </group>
          <group group_id="O6">
            <title>1.5 mg Dulaglutide (Part B-T2DM)</title>
            <description>1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics: Maximum Concentration (Cmax) of Dulaglutide</title>
          <description>Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B.</description>
          <population>Participants in Part A and Part B who received at least 1 dose of study drug and had evaluable Cmax data.</population>
          <units>nanograms per milliliter (ng/mL)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="11"/>
                <count group_id="O5" value="11"/>
                <count group_id="O6" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1 (Parts A and B)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.4" spread="39"/>
                    <measurement group_id="O2" value="44.2" spread="14"/>
                    <measurement group_id="O3" value="81.5" spread="21"/>
                    <measurement group_id="O4" value="20.7" spread="18"/>
                    <measurement group_id="O5" value="31.3" spread="23"/>
                    <measurement group_id="O6" value="52.6" spread="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 22 (Part B only)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Part A participants did not have data collected at this time point</measurement>
                    <measurement group_id="O2" value="NA" spread="NA">Part A participants did not have data collected at this time point</measurement>
                    <measurement group_id="O3" value="NA" spread="NA">Part A participants did not have data collected at this time point</measurement>
                    <measurement group_id="O4" value="26.3" spread="27"/>
                    <measurement group_id="O5" value="41.4" spread="18"/>
                    <measurement group_id="O6" value="70.2" spread="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetics: Time of Maximum Observed Concentration (Tmax) of Dulaglutide</title>
        <description>Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B.</description>
        <time_frame>Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose</time_frame>
        <population>Participants in Part A and Part B who received at least 1 dose of study drug and had evaluable Tmax data.</population>
        <group_list>
          <group group_id="O1">
            <title>0.5 mg Dulaglutide (Part A-Healthy)</title>
            <description>0.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A</description>
          </group>
          <group group_id="O2">
            <title>0.75 mg Dulaglutide (Part A-Healthy)</title>
            <description>0.75 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A</description>
          </group>
          <group group_id="O3">
            <title>1.5 mg Dulaglutide (Part A-Healthy)</title>
            <description>1.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A</description>
          </group>
          <group group_id="O4">
            <title>0.5 mg Dulaglutide (Part B-T2DM)</title>
            <description>0.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B</description>
          </group>
          <group group_id="O5">
            <title>0.75 mg Dulaglutide (Part B-T2DM)</title>
            <description>0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B</description>
          </group>
          <group group_id="O6">
            <title>1.5 mg Dulaglutide (Part B-T2DM)</title>
            <description>1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics: Time of Maximum Observed Concentration (Tmax) of Dulaglutide</title>
          <description>Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B.</description>
          <population>Participants in Part A and Part B who received at least 1 dose of study drug and had evaluable Tmax data.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="11"/>
                <count group_id="O5" value="11"/>
                <count group_id="O6" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1 (Parts A and B)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.02" lower_limit="12.02" upper_limit="48.02"/>
                    <measurement group_id="O2" value="48.00" lower_limit="24.00" upper_limit="48.00"/>
                    <measurement group_id="O3" value="48.00" lower_limit="24.00" upper_limit="48.00"/>
                    <measurement group_id="O4" value="48.00" lower_limit="47.92" upper_limit="72.00"/>
                    <measurement group_id="O5" value="48.00" lower_limit="24.00" upper_limit="72.00"/>
                    <measurement group_id="O6" value="71.98" lower_limit="24.00" upper_limit="96.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 22 (Part B only)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Part A participants did not have data collected at this time point</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Part A participants did not have data collected at this time point</measurement>
                    <measurement group_id="O3" value="NA" lower_limit="NA" upper_limit="NA">Part A participants did not have data collected at this time point</measurement>
                    <measurement group_id="O4" value="48.00" lower_limit="12.00" upper_limit="48.02"/>
                    <measurement group_id="O5" value="47.98" lower_limit="24.00" upper_limit="48.00"/>
                    <measurement group_id="O6" value="48.00" lower_limit="23.97" upper_limit="96.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetics: Area Under the Concentration-time Curve From Time Zero to 336 Hours Postdose (AUC[0-336]) of Dulaglutide</title>
        <description>Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B.</description>
        <time_frame>Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose</time_frame>
        <population>Participants in Part A and Part B who received at least 1 dose of study drug and had evaluable AUC(0-336) data.</population>
        <group_list>
          <group group_id="O1">
            <title>0.5 mg Dulaglutide (Part A-Healthy)</title>
            <description>0.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A</description>
          </group>
          <group group_id="O2">
            <title>0.75 mg Dulaglutide (Part A-Healthy)</title>
            <description>0.75 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A</description>
          </group>
          <group group_id="O3">
            <title>1.5 mg Dulaglutide (Part A-Healthy)</title>
            <description>1.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A</description>
          </group>
          <group group_id="O4">
            <title>0.5 mg Dulaglutide (Part B-T2DM)</title>
            <description>0.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B</description>
          </group>
          <group group_id="O5">
            <title>0.75 mg Dulaglutide (Part B-T2DM)</title>
            <description>0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B</description>
          </group>
          <group group_id="O6">
            <title>1.5 mg Dulaglutide (Part B-T2DM)</title>
            <description>1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics: Area Under the Concentration-time Curve From Time Zero to 336 Hours Postdose (AUC[0-336]) of Dulaglutide</title>
          <description>Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B.</description>
          <population>Participants in Part A and Part B who received at least 1 dose of study drug and had evaluable AUC(0-336) data.</population>
          <units>nanograms*hours per milliliter (ng*h/mL)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="11"/>
                <count group_id="O5" value="11"/>
                <count group_id="O6" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1 (Parts A and B; n = 6, 10, 11, 3, 8, 4)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4500" spread="42"/>
                    <measurement group_id="O2" value="6410" spread="14"/>
                    <measurement group_id="O3" value="11700" spread="12"/>
                    <measurement group_id="O4" value="3900" spread="7"/>
                    <measurement group_id="O5" value="5490" spread="19"/>
                    <measurement group_id="O6" value="10300" spread="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 22 (Part B only; n = 6, 10, 10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Part A participants did not have data collected at this time point</measurement>
                    <measurement group_id="O2" value="NA" spread="NA">Part A participants did not have data collected at this time point</measurement>
                    <measurement group_id="O3" value="NA" spread="NA">Part A participants did not have data collected at this time point</measurement>
                    <measurement group_id="O4" value="4720" spread="7"/>
                    <measurement group_id="O5" value="7030" spread="17"/>
                    <measurement group_id="O6" value="12500" spread="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetics: Half-life of Dulaglutide</title>
        <description>Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B.</description>
        <time_frame>Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose</time_frame>
        <population>Participants in Part A and Part B who received at least 1 dose of study drug and had evaluable half-life data.</population>
        <group_list>
          <group group_id="O1">
            <title>0.5 mg Dulaglutide (Part A-Healthy)</title>
            <description>0.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A</description>
          </group>
          <group group_id="O2">
            <title>0.75 mg Dulaglutide (Part A-Healthy)</title>
            <description>0.75 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A</description>
          </group>
          <group group_id="O3">
            <title>1.5 mg Dulaglutide (Part A-Healthy)</title>
            <description>1.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A</description>
          </group>
          <group group_id="O4">
            <title>0.5 mg Dulaglutide (Part B-T2DM)</title>
            <description>0.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B</description>
          </group>
          <group group_id="O5">
            <title>0.75 mg Dulaglutide (Part B-T2DM)</title>
            <description>0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B</description>
          </group>
          <group group_id="O6">
            <title>1.5 mg Dulaglutide (Part B-T2DM)</title>
            <description>1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics: Half-life of Dulaglutide</title>
          <description>Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B.</description>
          <population>Participants in Part A and Part B who received at least 1 dose of study drug and had evaluable half-life data.</population>
          <units>hours</units>
          <param>Geometric Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="10"/>
                <count group_id="O6" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1 (Parts A and B; n=6, 10, 11, 3, 8, 4)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.1" lower_limit="50.8" upper_limit="244"/>
                    <measurement group_id="O2" value="84.5" lower_limit="60.2" upper_limit="228"/>
                    <measurement group_id="O3" value="82.9" lower_limit="63.8" upper_limit="104"/>
                    <measurement group_id="O4" value="122" lower_limit="106" upper_limit="133"/>
                    <measurement group_id="O5" value="113" lower_limit="63.9" upper_limit="222"/>
                    <measurement group_id="O6" value="88.5" lower_limit="69.6" upper_limit="111"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 22 (Part B only; n=NA, NA, NA, 6, 10, 9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Part A participants did not have data collected at this time point</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Part A participants did not have data collected at this time point</measurement>
                    <measurement group_id="O3" value="NA" lower_limit="NA" upper_limit="NA">Part A participants did not have data collected at this time point</measurement>
                    <measurement group_id="O4" value="97.6" lower_limit="71.9" upper_limit="122"/>
                    <measurement group_id="O5" value="106" lower_limit="70.4" upper_limit="139"/>
                    <measurement group_id="O6" value="105" lower_limit="80.0" upper_limit="134"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part B - Pharmacodynamics: Area Under the Plasma Glucose Time Curve From Time Zero to 4 Hours Postmeal (gAUC[0-4])</title>
        <description>Pharmacodynamic parameters were assessed at baseline and on Days 3, 24, and 29 in Part B.</description>
        <time_frame>Baseline and Days 3, 24, and 29</time_frame>
        <population>Participants in Part B who received at least 1 dose of study drug and had evaluable gAUC(0-4) data.</population>
        <group_list>
          <group group_id="O1">
            <title>0.5 mg Dulaglutide (Part B-T2DM)</title>
            <description>0.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B</description>
          </group>
          <group group_id="O2">
            <title>0.75 mg Dulaglutide (Part B-T2DM)</title>
            <description>0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B</description>
          </group>
          <group group_id="O3">
            <title>1.5 mg Dulaglutide (Part B-T2DM)</title>
            <description>1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B</description>
          </group>
          <group group_id="O4">
            <title>Placebo (Part B-T2DM</title>
            <description>Placebo administered to participants with T2DM once weekly SQ for 4 weeks in Part B</description>
          </group>
        </group_list>
        <measure>
          <title>Part B - Pharmacodynamics: Area Under the Plasma Glucose Time Curve From Time Zero to 4 Hours Postmeal (gAUC[0-4])</title>
          <description>Pharmacodynamic parameters were assessed at baseline and on Days 3, 24, and 29 in Part B.</description>
          <population>Participants in Part B who received at least 1 dose of study drug and had evaluable gAUC(0-4) data.</population>
          <units>millimoles*hours per liter (mmol*h/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.3" spread="10.6"/>
                    <measurement group_id="O2" value="58.1" spread="11.7"/>
                    <measurement group_id="O3" value="53.4" spread="8.12"/>
                    <measurement group_id="O4" value="48.2" spread="7.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.2" spread="6.19"/>
                    <measurement group_id="O2" value="41.2" spread="11.9"/>
                    <measurement group_id="O3" value="32.2" spread="4.87"/>
                    <measurement group_id="O4" value="46.1" spread="8.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.7" spread="7.11"/>
                    <measurement group_id="O2" value="36.8" spread="7.08"/>
                    <measurement group_id="O3" value="30.5" spread="4.55"/>
                    <measurement group_id="O4" value="48.6" spread="9.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.6" spread="9.11"/>
                    <measurement group_id="O2" value="38.1" spread="7.40"/>
                    <measurement group_id="O3" value="31.8" spread="4.57"/>
                    <measurement group_id="O4" value="46.9" spread="6.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Placebo (Part A-Healthy)</title>
          <description>Placebo administered once SQ to healthy participants in 1 of 3 treatment periods&#xD;
Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms.</description>
        </group>
        <group group_id="E2">
          <title>0.5 mg Dulaglutide (Part A-Healthy)</title>
          <description>0.5 milligrams (mg) dulaglutide administered once subcutaneously (SQ) to healthy participants in 1 of 3 treatment periods&#xD;
Dulaglutide&#xD;
Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms.</description>
        </group>
        <group group_id="E3">
          <title>0.75 mg Dulaglutide (Part A-Healthy)</title>
          <description>0.75 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods&#xD;
Dulaglutide&#xD;
Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms.</description>
        </group>
        <group group_id="E4">
          <title>1.5 mg Dulaglutide (Part A-Healthy)</title>
          <description>1.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods&#xD;
Dulaglutide&#xD;
Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms.</description>
        </group>
        <group group_id="E5">
          <title>Placebo (Part B-T2DM)</title>
          <description>Placebo administered to participants with T2DM once weekly SQ for 4 weeks&#xD;
Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms.</description>
        </group>
        <group group_id="E6">
          <title>0.5 mg Dulaglutide (Part B-T2DM)</title>
          <description>0.5 mg dulaglutide administered to participants with Type 2 diabetes mellitus (T2DM) once weekly SQ for 4 weeks&#xD;
Dulaglutide&#xD;
Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms.</description>
        </group>
        <group group_id="E7">
          <title>0.75 mg Dulaglutide (Part B-T2DM)</title>
          <description>0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks&#xD;
Dulaglutide&#xD;
Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms.</description>
        </group>
        <group group_id="E8">
          <title>1.5 mg Dulaglutide (Part B-T2DM)</title>
          <description>1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks&#xD;
Dulaglutide&#xD;
Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 15.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 15.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="11"/>
                <counts group_id="E7" subjects_affected="5" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" events="2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Eructation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Regurgitation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood glucose increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Blood pressure decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Heart rate abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Chief Medical Officer</name_or_title>
      <organization>Eli Lilly and Company</organization>
      <phone>800-545-5979</phone>
    </point_of_contact>
  </clinical_results>
</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/NCT01667900
org study id: 12925
secondary id: H9X-EW-GBDL
nct id: NCT01667900
lead sponsor: 
has dmc: No
This is a study of dulaglutide in Chinese participants. The purpose of the study is to
      determine how the body processes dulaglutide and how dulaglutide affects the body. This study
      has 2 parts: Part A - single dose of dulaglutide administered to healthy participants in 2 of
      3 study periods. There is a minimum 28-day washout between periods. Part A will last
      approximately 16 weeks. Part B - multiple doses of dulaglutide administered to participants
      with Type 2 diabetes mellitus (T2DM). Part B will last approximately 15 weeks.

      Doses of 0.5 milligrams (mg), 0.75 mg, and 1.5 mg of dulaglutide will be evaluated in this
      study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Pharmacokinetics: Maximum Concentration (Cmax) of Dulaglutide
time frame: Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose
description: Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B.
measure: Pharmacokinetics: Time of Maximum Observed Concentration (Tmax) of Dulaglutide
time frame: Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose
description: Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B.
measure: Pharmacokinetics: Area Under the Concentration-time Curve From Time Zero to 336 Hours Postdose (AUC[0-336]) of Dulaglutide
time frame: Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose
description: Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B.
measure: Pharmacokinetics: Half-life of Dulaglutide
time frame: Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose
description: Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B.
measure: Part B - Pharmacodynamics: Area Under the Plasma Glucose Time Curve From Time Zero to 4 Hours Postmeal (gAUC[0-4])
time frame: Baseline and Days 3, 24, and 29
description: Pharmacodynamic parameters were assessed at baseline and on Days 3, 24, and 29 in Part B.
arm group label: 0.5 mg Dulaglutide (Part A-Healthy)
arm group type: Experimental
description: 0.5 milligrams (mg) dulaglutide administered once subcutaneously (SQ) to healthy participants in 1 of 3 treatment periods
arm group label: 0.75 mg Dulaglutide (Part A-Healthy)
arm group type: Experimental
description: 0.75 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods
arm group label: 1.5 mg Dulaglutide (Part A-Healthy)
arm group type: Experimental
description: 1.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods
arm group label: Placebo (Part A-Healthy)
arm group type: Placebo Comparator
description: Placebo administered once SQ to healthy participants in 1 of 3 treatment periods
arm group label: 0.5 mg Dulaglutide (Part B-T2DM)
arm group type: Experimental
description: 0.5 mg dulaglutide administered to participants with Type 2 diabetes mellitus (T2DM) once weekly SQ for 4 weeks
arm group label: 0.75 mg Dulaglutide (Part B-T2DM)
arm group type: Experimental
description: 0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks
arm group label: 1.5 mg Dulaglutide (Part B-T2DM)
arm group type: Experimental
description: 1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks
arm group label: Placebo (Part B-T2DM)
arm group type: Placebo Comparator
description: Placebo administered to participants with T2DM once weekly SQ for 4 weeks
intervention type: Drug
intervention name: Dulaglutide
arm group label: 0.5 mg Dulaglutide (Part A-Healthy)
arm group label: 0.5 mg Dulaglutide (Part B-T2DM)
arm group label: 0.75 mg Dulaglutide (Part A-Healthy)
arm group label: 0.75 mg Dulaglutide (Part B-T2DM)
arm group label: 1.5 mg Dulaglutide (Part A-Healthy)
arm group label: 1.5 mg Dulaglutide (Part B-T2DM)
other name: LY2189265
intervention type: Drug
intervention name: Placebo
description: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms.
arm group label: 0.5 mg Dulaglutide (Part A-Healthy)
arm group label: 0.5 mg Dulaglutide (Part B-T2DM)
arm group label: 0.75 mg Dulaglutide (Part A-Healthy)
arm group label: 0.75 mg Dulaglutide (Part B-T2DM)
arm group label: 1.5 mg Dulaglutide (Part A-Healthy)
arm group label: 1.5 mg Dulaglutide (Part B-T2DM)
arm group label: Placebo (Part A-Healthy)
arm group label: Placebo (Part B-T2DM)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM- 5 PM Eastern time (UTC/GMT -5 hours, EST)
role: Study Director
affiliation: Eli Lilly and Company
facility: 
country: China
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 2
mesh term: Dulaglutide
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 