<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/NCT02973100</url>
  </required_header>
  <id_info>
    <org_study_id>16568</org_study_id>
    <secondary_id>H9X-MC-GBGJ</secondary_id>
    <secondary_id>2016-002494-34</secondary_id>
    <nct_id>NCT02973100</nct_id>
  </id_info>
  <brief_title>A Study of Investigational Dulaglutide Doses in Participants With Type 2 Diabetes on Metformin Monotherapy</brief_title>
  <official_title>A Phase 2, Double-Blind, Placebo-Controlled, 18-Week Trial of Investigational Dulaglutide Doses Versus Placebo in Patients With Type 2 Diabetes on Metformin Monotherapy</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>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy and safety of investigational doses of&#xD;
      dulaglutide in participants with type 2 diabetes on metformin monotherapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">August 14, 2017</completion_date>
  <primary_completion_date type="Actual">July 15, 2017</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Hemoglobin A1c (HbA1c)</measure>
    <time_frame>Baseline, Week 18</time_frame>
    <description>HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.&#xD;
Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with baseline as a covariate, pooled country, treatment, time, treatment*time as fixed effects.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With HbA1c of &lt;7.0%</measure>
    <time_frame>Week 18</time_frame>
    <description>Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Fasting Serum Glucose (FSG)</measure>
    <time_frame>Baseline, Week 18</time_frame>
    <description>Fasting serum glucose (FSG) is a test to determine how much glucose (sugar) is in a serum sample after an overnight fast. Least Squares (LS) means was determined by MMRM methodology with baseline as a covariate, pooled country, baseline HbA1c strata using &gt;=8% as cutoff, treatment, time, treatment*time as fixed effects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Body Weight</measure>
    <time_frame>Baseline, Week 18</time_frame>
    <description>Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with baseline as a covariate, pooled country, baseline HbA1c strata using &gt;=8% as cutoff, treatment, time, treatment*time as fixed effects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Discontinuing Study Drug Due to Adverse Events</measure>
    <time_frame>Baseline through Week 18</time_frame>
    <description>Adverse event (AE) defined as any unfavorable medical event, newly emerged or a deterioration of a preexisting condition, in other words any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship, that occurred after the visit for informed consent and up to the visit for completion of administration, or discontinuation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Documented Symptomatic Hypoglycemia</measure>
    <time_frame>Week 18</time_frame>
    <description>Hypoglycemic events (HE) were classified as severe, documented symptomatic (defined as an HE with typical symptoms of hypoglycemia and a blood glucose level of ≤3.9 millimoles per liter [mmol/L]). Hypoglycemia rate per 30 days was summarized at each visit by treatment group. The rate of hypoglycemia was analyzed using a generalized estimation equations model with a negative binomial distribution and a Log link. LS mean was determined by MMRM methodology with baseline hypoglycemia rate, pooled country, HbA1c at Baseline, treatment, with log of exposure in days divided by 365.25 as the offset.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK): The Maximum Drug Concentration at Steady State (Cmax,ss) of Dulaglutide</measure>
    <time_frame>0, 2, 4, 6, 10, 18, 22 weeks and early termination</time_frame>
    <description>Plasma samples for PK analysis were combined measure obtained from 0, 2, 4, 6, 10, 18, 22 weeks and until early termination of the visit. Cmax takes all time points post dose into account and one value was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics: Area Under the Concentration-Time Curve at Steady State From Time Zero to 168 Hours (AUC[0-168], ss) of Dulaglutide</measure>
    <time_frame>0, 2, 4, 6, 10, 18, 22 weeks and early termination</time_frame>
    <description>AUC[0-168h] is a combined measure obtained from 0, 2, 4, 6, 10, 18, 22 weeks and until early termination of the visit.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">318</enrollment>
  <condition>Type 2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Dulaglutide 4.5mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>4.5mg of Dulaglutide administered subcutaneously (SC)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dulaglutide 3.0mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3.0mg of Dulaglutide administered SC</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dulaglutide 1.5mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>1.5mg of Dulaglutide administered SC</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo administered SC</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dulaglutide</intervention_name>
    <description>Administered SC</description>
    <arm_group_label>Dulaglutide 1.5mg</arm_group_label>
    <arm_group_label>Dulaglutide 3.0mg</arm_group_label>
    <arm_group_label>Dulaglutide 4.5mg</arm_group_label>
    <other_name>LY2189265</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Administered SC</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have had type 2 diabetes (T2D) for ≥6 months according to the World Health&#xD;
             Organization (WHO) classification&#xD;
&#xD;
          -  Have HbA1c of 7.0% to 10.0%, inclusive, as assessed by the central laboratory&#xD;
&#xD;
          -  Have been treated with stable doses of metformin for at least 3 months&#xD;
&#xD;
          -  Have a body mass index (BMI) ≥25 kilograms per square meter&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have type 1 diabetes (T1D)&#xD;
&#xD;
          -  Have used any glucose-lowering medication other than metformin 3 months prior to study&#xD;
             entry or during screening/lead-in period or have used any glucagon-like peptide-1&#xD;
             receptor agonists (GLP-1 RAs) at any time in the past&#xD;
&#xD;
          -  Have had any of the following cardiovascular conditions: acute myocardial infarction&#xD;
             (MI), New York Heart Association Class III or Class IV heart failure, or&#xD;
             cerebrovascular accident (stroke)&#xD;
&#xD;
          -  Have acute or chronic hepatitis, signs and symptoms of any other liver disease other&#xD;
             than nonalcoholic fatty liver disease (NAFLD), or alanine aminotransferase (ALT) level&#xD;
             &gt;2.5 times the upper limit of the reference range, as determined by the central&#xD;
             laboratory at study entry; participants with NAFLD are eligible for participation in&#xD;
             this trial&#xD;
&#xD;
          -  Have had chronic or acute pancreatitis any time prior to study entry&#xD;
&#xD;
          -  Have an estimated glomerular filtration rate (eGFR) &lt;45 milliliters/minute/1.73 square&#xD;
             meter, calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation&#xD;
&#xD;
          -  Have serum calcitonin ≥20 picograms per milliliter, as determined by the central&#xD;
             laboratory at study entry&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</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>Parexel Early Phase Unit at Glendale</name>
      <address>
        <city>Glendale</city>
        <state>California</state>
        <zip>91206-4140</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marin Endocrine Associates</name>
      <address>
        <city>Greenbrae</city>
        <state>California</state>
        <zip>94904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Research Institute</name>
      <address>
        <city>Huntington Park</city>
        <state>California</state>
        <zip>90255</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Research Institute</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Catalina Research Institute, LLC</name>
      <address>
        <city>Montclair</city>
        <state>California</state>
        <zip>91763</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Artemis Institute for Clinical Research</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Encompass Clinical Research</name>
      <address>
        <city>Spring Valley Lake</city>
        <state>California</state>
        <zip>91978</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Clinical Investigators, Inc.</name>
      <address>
        <city>Tustin</city>
        <state>California</state>
        <zip>92780</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Infosphere</name>
      <address>
        <city>Van Nuys</city>
        <state>California</state>
        <zip>91405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diablo Clinical Research</name>
      <address>
        <city>Walnut Creek</city>
        <state>California</state>
        <zip>94598</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chase Medical Research, LLC</name>
      <address>
        <city>Waterbury</city>
        <state>Connecticut</state>
        <zip>06708</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Axes Medical Research, LLC</name>
      <address>
        <city>Cooper City</city>
        <state>Florida</state>
        <zip>33024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research of South Florida</name>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <zip>33134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East Coast Institute For Research</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Suncoast Research Group, LLC</name>
      <address>
        <city>Miami Lakes</city>
        <state>Florida</state>
        <zip>33135</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Horizon Research Center</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33175</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Palm Harbor Medical Associates</name>
      <address>
        <city>Palm Harbor</city>
        <state>Florida</state>
        <zip>34684</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>In-Quest Medical Research, LLC - Norcross</name>
      <address>
        <city>Norcross</city>
        <state>Georgia</state>
        <zip>30071</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East West Medical Institute</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96814</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elite Cilnical Trials LLLP</name>
      <address>
        <city>Blackfoot</city>
        <state>Idaho</state>
        <zip>83221</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Solaris Clinical Research</name>
      <address>
        <city>Meridian</city>
        <state>Idaho</state>
        <zip>83646</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HSHS Medical Group Diabetes Research</name>
      <address>
        <city>Springfield</city>
        <state>Illinois</state>
        <zip>62711</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>American Health Network</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46254</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Iderc, P.L.C.</name>
      <address>
        <city>Des Moines</city>
        <state>Iowa</state>
        <zip>50314</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cotton O'Neil Diabetes and Endocrinology Center</name>
      <address>
        <city>Topeka</city>
        <state>Kansas</state>
        <zip>66606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ActivMed Practices &amp; Research, Inc</name>
      <address>
        <city>Methuen</city>
        <state>Massachusetts</state>
        <zip>01844</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>StudyMetrix Research, LLC</name>
      <address>
        <city>Saint Peters</city>
        <state>Missouri</state>
        <zip>63303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Manhattan Medical Research</name>
      <address>
        <city>New York Mills</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>High Point Clinical Trials Center</name>
      <address>
        <city>High Point</city>
        <state>North Carolina</state>
        <zip>27265</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aventiv Research</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Corvallis Clinic P.C.</name>
      <address>
        <city>Corvallis</city>
        <state>Oregon</state>
        <zip>97330</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heritage Valley Medical Group, Inc.</name>
      <address>
        <city>Beaver</city>
        <state>Pennsylvania</state>
        <zip>15009</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Phase Research &amp; Development</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37909</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dallas Diabetes Endocrine Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Consano Clinical Research</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinpoint Trial, LLC</name>
      <address>
        <city>Waxahachie</city>
        <state>Texas</state>
        <zip>75165</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chrysalis Clinical Research</name>
      <address>
        <city>Saint George</city>
        <state>Utah</state>
        <zip>84790</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rainier Clinical Research Center</name>
      <address>
        <city>Renton</city>
        <state>Washington</state>
        <zip>98057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <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>Brandýs Nad Labem-Stará Boleslav</city>
        <zip>25001</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <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>Krnov</city>
        <zip>79401</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <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>Praha 1</city>
        <zip>11000</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <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>Praha 4 - Krc</city>
        <zip>140 59</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <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>Praha 4</city>
        <zip>149 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <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>Praha 8</city>
        <zip>181 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <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>Chihuahua</city>
        <zip>31217</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <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>Cuernavaca</city>
        <zip>62250</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <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>Guadalajara</city>
        <zip>04460</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <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>Monterrey</city>
        <zip>64460</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <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>Tampico</city>
        <zip>89000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <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>Bialystok</city>
        <zip>15-404</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <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>Bialystok</city>
        <zip>15-445</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <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>Gdansk</city>
        <zip>80-546</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <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>Lodz</city>
        <zip>90-242</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <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>Lublin</city>
        <zip>20-333</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <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>Lublin</city>
        <zip>20-538</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <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>Poznan</city>
        <zip>61-655</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <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>Poznan</city>
        <zip>61-853</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <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>Ruda Slaska</city>
        <zip>41-709</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <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>Szczecin</city>
        <zip>70-506</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marginal Doctor's Center</name>
      <address>
        <city>Manati</city>
        <zip>00674</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>American Telemedicine Center</name>
      <address>
        <city>San Juan</city>
        <zip>00917</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <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>Alba Iulia</city>
        <zip>510053</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <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>Baia Mare</city>
        <zip>430222</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <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>Iasi</city>
        <zip>700547</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <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>Oradea</city>
        <zip>410159</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <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>Satu-Mare</city>
        <zip>440055</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czechia</country>
    <country>Mexico</country>
    <country>Poland</country>
    <country>Puerto Rico</country>
    <country>Romania</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
  </removed_countries>
  <link>
    <url>https://www.lillytrialguide.com/en-US/studies/type-2-diabetes/GBGJ#?postal=</url>
    <description>A Study of Investigational Dulaglutide Doses in Participants With Type 2 Diabetes on Metformin Monotherapy</description>
  </link>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 25, 2016</study_first_posted>
  <results_first_submitted>July 13, 2018</results_first_submitted>
  <results_first_submitted_qc>August 22, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">August 24, 2018</results_first_posted>
  <last_update_submitted>September 5, 2019</last_update_submitted>
  <last_update_submitted_qc>September 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dulaglutide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.</ipd_time_frame>
    <ipd_access_criteria>A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.</ipd_access_criteria>
    <ipd_url>https://vivli.org/</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 8, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/00/NCT02973100/SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 7, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/00/NCT02973100/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study consisted of 3 periods: an approximately 2-week lead-in period, followed by an 18-week treatment period, and a 4-week safety follow-up period.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Participants received placebo once weekly (QW) by subcutaneous (SC) injection.</description>
        </group>
        <group group_id="P2">
          <title>Dulaglutide 1.5 Milligrams (mg)</title>
          <description>Participants received 1.5mg of dulaglutide QW by SC injection.</description>
        </group>
        <group group_id="P3">
          <title>Dulaglutide 3.0mg</title>
          <description>Participants received 3.0mg of dulaglutide QW by SC injection.</description>
        </group>
        <group group_id="P4">
          <title>Dulaglutide 4.5mg</title>
          <description>Participants received 4.5mg of dulaglutide QW by SC injection.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="82"/>
                <participants group_id="P2" count="81"/>
                <participants group_id="P3" count="79"/>
                <participants group_id="P4" count="76"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received at Least 1 Dose of Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="81"/>
                <participants group_id="P2" count="81"/>
                <participants group_id="P3" count="79"/>
                <participants group_id="P4" count="76"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="75"/>
                <participants group_id="P2" count="73"/>
                <participants group_id="P3" count="75"/>
                <participants group_id="P4" count="69"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Notification of change in address</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="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Failed to attend Safety followup period</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Participants received placebo once weekly (QW) by subcutaneous (SC) injection.</description>
        </group>
        <group group_id="B2">
          <title>Dulaglutide 1.5mg</title>
          <description>Participants received 1.5mg of dulaglutide QW by SC injection.</description>
        </group>
        <group group_id="B3">
          <title>Dulaglutide 3.0mg</title>
          <description>Participants received 3.0mg of dulaglutide QW by SC injection.</description>
        </group>
        <group group_id="B4">
          <title>Dulaglutide 4.5mg</title>
          <description>Participants received 4.5mg of dulaglutide QW by SC injection.</description>
        </group>
        <group group_id="B5">
          <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="81"/>
            <count group_id="B2" value="81"/>
            <count group_id="B3" value="79"/>
            <count group_id="B4" value="76"/>
            <count group_id="B5" value="317"/>
          </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="56.52" spread="8.93"/>
                    <measurement group_id="B2" value="57.65" spread="9.79"/>
                    <measurement group_id="B3" value="55.90" spread="10.74"/>
                    <measurement group_id="B4" value="57.13" spread="9.63"/>
                    <measurement group_id="B5" value="56.80" spread="9.77"/>
                  </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="33"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="44"/>
                    <measurement group_id="B4" value="40"/>
                    <measurement group_id="B5" value="159"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="35"/>
                    <measurement group_id="B4" value="36"/>
                    <measurement group_id="B5" value="158"/>
                  </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="35"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="38"/>
                    <measurement group_id="B4" value="30"/>
                    <measurement group_id="B5" value="135"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                    <measurement group_id="B2" value="49"/>
                    <measurement group_id="B3" value="40"/>
                    <measurement group_id="B4" value="45"/>
                    <measurement group_id="B5" value="180"/>
                  </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="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="2"/>
                  </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="10"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="59"/>
                    <measurement group_id="B2" value="68"/>
                    <measurement group_id="B3" value="58"/>
                    <measurement group_id="B4" value="59"/>
                    <measurement group_id="B5" value="244"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="12"/>
                  </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="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Romania</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="44"/>
                    <measurement group_id="B4" value="43"/>
                    <measurement group_id="B5" value="174"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Czechia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mexico</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="11"/>
                    <measurement group_id="B5" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Hemoglobin A1c (HbA1c)</title>
          <description>HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time.</description>
          <units>Percentage of glycosylated hemoglobin</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.08" spread="0.79"/>
                    <measurement group_id="B2" value="8.02" spread="0.80"/>
                    <measurement group_id="B3" value="8.16" spread="0.92"/>
                    <measurement group_id="B4" value="8.12" spread="0.81"/>
                    <measurement group_id="B5" value="8.09" spread="0.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Hemoglobin A1c (HbA1c)</title>
        <description>HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.&#xD;
Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with baseline as a covariate, pooled country, treatment, time, treatment*time as fixed effects.</description>
        <time_frame>Baseline, Week 18</time_frame>
        <population>All randomized participants who received at least one dose of study drug and had postbaseline values, excluding post rescue data for Hemoglobin A1c.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo once weekly (QW) by subcutaneous (SC) injection.</description>
          </group>
          <group group_id="O2">
            <title>Dulaglutide 1.5mg</title>
            <description>Participants received 1.5mg of dulaglutide QW by SC injection.</description>
          </group>
          <group group_id="O3">
            <title>Dulaglutide 3.0mg</title>
            <description>Participants received 3.0mg of dulaglutide QW by SC injection.</description>
          </group>
          <group group_id="O4">
            <title>Dulaglutide 4.5mg</title>
            <description>Participants received 4.5mg of dulaglutide QW by SC injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Hemoglobin A1c (HbA1c)</title>
          <description>HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.&#xD;
Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with baseline as a covariate, pooled country, treatment, time, treatment*time as fixed effects.</description>
          <population>All randomized participants who received at least one dose of study drug and had postbaseline values, excluding post rescue data for Hemoglobin A1c.</population>
          <units>Percentage of glycosylated hemoglobin</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="73"/>
                <count group_id="O3" value="73"/>
                <count group_id="O4" value="66"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.44" spread="0.101"/>
                    <measurement group_id="O2" value="-1.23" spread="0.099"/>
                    <measurement group_id="O3" value="-1.31" spread="0.099"/>
                    <measurement group_id="O4" value="-1.40" spread="0.103"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.80</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.07</ci_lower_limit>
            <ci_upper_limit>-0.53</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.87</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.14</ci_lower_limit>
            <ci_upper_limit>-0.60</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.96</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.24</ci_lower_limit>
            <ci_upper_limit>-0.69</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With HbA1c of &lt;7.0%</title>
        <description>Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.</description>
        <time_frame>Week 18</time_frame>
        <population>All randomized participants who received at least one dose of study drug and had postbaseline values, excluding post rescue data for Hemoglobin A1c.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo once weekly (QW) by subcutaneous (SC) injection.</description>
          </group>
          <group group_id="O2">
            <title>Dulaglutide 1.5mg</title>
            <description>Participants received 1.5mg of dulaglutide QW by SC injection.</description>
          </group>
          <group group_id="O3">
            <title>Dulaglutide 3.0mg</title>
            <description>Participants received 3.0mg of dulaglutide QW by SC injection.</description>
          </group>
          <group group_id="O4">
            <title>Dulaglutide 4.5mg</title>
            <description>Participants received 4.5mg of dulaglutide QW by SC injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With HbA1c of &lt;7.0%</title>
          <description>Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.</description>
          <population>All randomized participants who received at least one dose of study drug and had postbaseline values, excluding post rescue data for Hemoglobin A1c.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="73"/>
                <count group_id="O3" value="73"/>
                <count group_id="O4" value="66"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="71.2"/>
                    <measurement group_id="O3" value="71.2"/>
                    <measurement group_id="O4" value="68.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.001</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>24.489</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>8.368</ci_lower_limit>
            <ci_upper_limit>71.667</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.001</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>27.906</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>9.238</ci_lower_limit>
            <ci_upper_limit>84.300</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.001</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>21.852</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>7.672</ci_lower_limit>
            <ci_upper_limit>62.242</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Fasting Serum Glucose (FSG)</title>
        <description>Fasting serum glucose (FSG) is a test to determine how much glucose (sugar) is in a serum sample after an overnight fast. Least Squares (LS) means was determined by MMRM methodology with baseline as a covariate, pooled country, baseline HbA1c strata using &gt;=8% as cutoff, treatment, time, treatment*time as fixed effects.</description>
        <time_frame>Baseline, Week 18</time_frame>
        <population>All randomized participants who received at least one dose of study drug and had postbaseline values, excluding post rescue data for FSG.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo once weekly (QW) by subcutaneous (SC) injection.</description>
          </group>
          <group group_id="O2">
            <title>Dulaglutide 1.5mg</title>
            <description>Participants received 1.5mg of dulaglutide QW by SC injection.</description>
          </group>
          <group group_id="O3">
            <title>Dulaglutide 3.0mg</title>
            <description>Participants received 3.0mg of dulaglutide QW by SC injection.</description>
          </group>
          <group group_id="O4">
            <title>Dulaglutide 4.5mg</title>
            <description>Participants received 4.5mg of dulaglutide QW by SC injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Fasting Serum Glucose (FSG)</title>
          <description>Fasting serum glucose (FSG) is a test to determine how much glucose (sugar) is in a serum sample after an overnight fast. Least Squares (LS) means was determined by MMRM methodology with baseline as a covariate, pooled country, baseline HbA1c strata using &gt;=8% as cutoff, treatment, time, treatment*time as fixed effects.</description>
          <population>All randomized participants who received at least one dose of study drug and had postbaseline values, excluding post rescue data for FSG.</population>
          <units>millimole/liter (mmol/L)</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="62"/>
                <count group_id="O3" value="67"/>
                <count group_id="O4" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.69" spread="0.257"/>
                    <measurement group_id="O2" value="-2.01" spread="0.261"/>
                    <measurement group_id="O3" value="-1.92" spread="0.250"/>
                    <measurement group_id="O4" value="-2.11" spread="0.263"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.32</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.02</ci_lower_limit>
            <ci_upper_limit>-0.62</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.23</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.91</ci_lower_limit>
            <ci_upper_limit>-0.54</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.42</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.12</ci_lower_limit>
            <ci_upper_limit>-0.72</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Body Weight</title>
        <description>Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with baseline as a covariate, pooled country, baseline HbA1c strata using &gt;=8% as cutoff, treatment, time, treatment*time as fixed effects.</description>
        <time_frame>Baseline, Week 18</time_frame>
        <population>All randomized participants who received at least one dose of study drug and had postbaseline values, excluding post rescue data for body weight.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo once weekly (QW) by subcutaneous (SC) injection.</description>
          </group>
          <group group_id="O2">
            <title>Dulaglutide 1.5mg</title>
            <description>Participants received 1.5mg of dulaglutide QW by SC injection.</description>
          </group>
          <group group_id="O3">
            <title>Dulaglutide 3.0mg</title>
            <description>Participants received 3.0mg of dulaglutide QW by SC injection.</description>
          </group>
          <group group_id="O4">
            <title>Dulaglutide 4.5mg</title>
            <description>Participants received 4.5mg of dulaglutide QW by SC injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Body Weight</title>
          <description>Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with baseline as a covariate, pooled country, baseline HbA1c strata using &gt;=8% as cutoff, treatment, time, treatment*time as fixed effects.</description>
          <population>All randomized participants who received at least one dose of study drug and had postbaseline values, excluding post rescue data for body weight.</population>
          <units>Kilograms (Kg)</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="72"/>
                <count group_id="O3" value="74"/>
                <count group_id="O4" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.6" spread="0.39"/>
                    <measurement group_id="O2" value="-2.8" spread="0.39"/>
                    <measurement group_id="O3" value="-3.9" spread="0.39"/>
                    <measurement group_id="O4" value="-4.1" spread="0.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.025</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.3</ci_lower_limit>
            <ci_upper_limit>-0.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-2.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.4</ci_lower_limit>
            <ci_upper_limit>-1.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-2.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.7</ci_lower_limit>
            <ci_upper_limit>-1.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Discontinuing Study Drug Due to Adverse Events</title>
        <description>Adverse event (AE) defined as any unfavorable medical event, newly emerged or a deterioration of a preexisting condition, in other words any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship, that occurred after the visit for informed consent and up to the visit for completion of administration, or discontinuation.</description>
        <time_frame>Baseline through Week 18</time_frame>
        <population>All randomized participants who received study drug and had postbaseline data for safety analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo once weekly (QW) by subcutaneous (SC) injection.</description>
          </group>
          <group group_id="O2">
            <title>Dulaglutide 1.5mg</title>
            <description>Participants received 1.5mg of dulaglutide QW by SC injection.</description>
          </group>
          <group group_id="O3">
            <title>Dulaglutide 3.0mg</title>
            <description>Participants received 3.0mg of dulaglutide QW by SC injection.</description>
          </group>
          <group group_id="O4">
            <title>Dulaglutide 4.5mg</title>
            <description>Participants received 4.5mg of dulaglutide QW by SC injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Discontinuing Study Drug Due to Adverse Events</title>
          <description>Adverse event (AE) defined as any unfavorable medical event, newly emerged or a deterioration of a preexisting condition, in other words any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship, that occurred after the visit for informed consent and up to the visit for completion of administration, or discontinuation.</description>
          <population>All randomized participants who received study drug and had postbaseline data for safety analyses.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
                <count group_id="O2" value="81"/>
                <count group_id="O3" value="79"/>
                <count group_id="O4" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.9"/>
                    <measurement group_id="O2" value="6.2"/>
                    <measurement group_id="O3" value="10.1"/>
                    <measurement group_id="O4" value="13.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of Documented Symptomatic Hypoglycemia</title>
        <description>Hypoglycemic events (HE) were classified as severe, documented symptomatic (defined as an HE with typical symptoms of hypoglycemia and a blood glucose level of ≤3.9 millimoles per liter [mmol/L]). Hypoglycemia rate per 30 days was summarized at each visit by treatment group. The rate of hypoglycemia was analyzed using a generalized estimation equations model with a negative binomial distribution and a Log link. LS mean was determined by MMRM methodology with baseline hypoglycemia rate, pooled country, HbA1c at Baseline, treatment, with log of exposure in days divided by 365.25 as the offset.</description>
        <time_frame>Week 18</time_frame>
        <population>All randomized participants who received at least one dose of study drug and had postbaseline values, excluding post rescue values for hypoglycemic episodes.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo once weekly (QW) by subcutaneous (SC) injection.</description>
          </group>
          <group group_id="O2">
            <title>Dulaglutide 1.5mg</title>
            <description>Participants received 1.5mg of dulaglutide QW by SC injection.</description>
          </group>
          <group group_id="O3">
            <title>Dulaglutide 3.0mg</title>
            <description>Participants received 3.0mg of dulaglutide QW by SC injection.</description>
          </group>
          <group group_id="O4">
            <title>Dulaglutide 4.5mg</title>
            <description>Participants received 4.5mg of dulaglutide QW by SC injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Documented Symptomatic Hypoglycemia</title>
          <description>Hypoglycemic events (HE) were classified as severe, documented symptomatic (defined as an HE with typical symptoms of hypoglycemia and a blood glucose level of ≤3.9 millimoles per liter [mmol/L]). Hypoglycemia rate per 30 days was summarized at each visit by treatment group. The rate of hypoglycemia was analyzed using a generalized estimation equations model with a negative binomial distribution and a Log link. LS mean was determined by MMRM methodology with baseline hypoglycemia rate, pooled country, HbA1c at Baseline, treatment, with log of exposure in days divided by 365.25 as the offset.</description>
          <population>All randomized participants who received at least one dose of study drug and had postbaseline values, excluding post rescue values for hypoglycemic episodes.</population>
          <units>Episodes/participant/365.25 days</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="81"/>
                <count group_id="O2" value="81"/>
                <count group_id="O3" value="79"/>
                <count group_id="O4" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.000"/>
                    <measurement group_id="O2" value="0.00" spread="0.000"/>
                    <measurement group_id="O3" value="0.00" spread="0.000"/>
                    <measurement group_id="O4" value="0.00" spread="0.001"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics (PK): The Maximum Drug Concentration at Steady State (Cmax,ss) of Dulaglutide</title>
        <description>Plasma samples for PK analysis were combined measure obtained from 0, 2, 4, 6, 10, 18, 22 weeks and until early termination of the visit. Cmax takes all time points post dose into account and one value was reported.</description>
        <time_frame>0, 2, 4, 6, 10, 18, 22 weeks and early termination</time_frame>
        <population>All randomized participants who received at least one dose of the study drug and have evaluable PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>Dulaglutide 1.5mg</title>
            <description>Participants received 1.5mg of dulaglutide QW by SC injection.</description>
          </group>
          <group group_id="O2">
            <title>Dulaglutide 3.0mg</title>
            <description>Participants received 3.0mg of dulaglutide QW by SC injection.</description>
          </group>
          <group group_id="O3">
            <title>Dulaglutide 4.5mg</title>
            <description>Participants received 4.5mg of dulaglutide QW by SC injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK): The Maximum Drug Concentration at Steady State (Cmax,ss) of Dulaglutide</title>
          <description>Plasma samples for PK analysis were combined measure obtained from 0, 2, 4, 6, 10, 18, 22 weeks and until early termination of the visit. Cmax takes all time points post dose into account and one value was reported.</description>
          <population>All randomized participants who received at least one dose of the study drug and have evaluable PK data.</population>
          <units>nanogram per milliliter (ng/mL)</units>
          <param>Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="81"/>
                <count group_id="O2" value="79"/>
                <count group_id="O3" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.4" lower_limit="38.9" upper_limit="170"/>
                    <measurement group_id="O2" value="151" lower_limit="64.3" upper_limit="277"/>
                    <measurement group_id="O3" value="204" lower_limit="87.2" upper_limit="377"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics: Area Under the Concentration-Time Curve at Steady State From Time Zero to 168 Hours (AUC[0-168], ss) of Dulaglutide</title>
        <description>AUC[0-168h] is a combined measure obtained from 0, 2, 4, 6, 10, 18, 22 weeks and until early termination of the visit.</description>
        <time_frame>0, 2, 4, 6, 10, 18, 22 weeks and early termination</time_frame>
        <population>All randomized participants who received at least one dose of the study drug and have evaluable PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>Dulaglutide 1.5mg</title>
            <description>Participants received 1.5mg of dulaglutide QW by SC injection.</description>
          </group>
          <group group_id="O2">
            <title>Dulaglutide 3.0mg</title>
            <description>Participants received 3.0mg of dulaglutide QW by SC injection.</description>
          </group>
          <group group_id="O3">
            <title>Dulaglutide 4.5mg</title>
            <description>Participants received 4.5mg of dulaglutide QW by SC injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics: Area Under the Concentration-Time Curve at Steady State From Time Zero to 168 Hours (AUC[0-168], ss) of Dulaglutide</title>
          <description>AUC[0-168h] is a combined measure obtained from 0, 2, 4, 6, 10, 18, 22 weeks and until early termination of the visit.</description>
          <population>All randomized participants who received at least one dose of the study drug and have evaluable PK data.</population>
          <units>nanogram*hour per milliliter (ng*h/mL)</units>
          <param>Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="81"/>
                <count group_id="O2" value="79"/>
                <count group_id="O3" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11800" lower_limit="5300" upper_limit="21300"/>
                    <measurement group_id="O2" value="26700" lower_limit="15300" upper_limit="41400"/>
                    <measurement group_id="O3" value="36600" lower_limit="21100" upper_limit="56500"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 22 weeks</time_frame>
      <desc>All participants who received at least one dose of study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Participants received placebo once weekly (QW) by subcutaneous (SC) injection.</description>
        </group>
        <group group_id="E2">
          <title>Dulaglutide 1.5mg</title>
          <description>Participants received 1.5mg of dulaglutide QW by SC injection.</description>
        </group>
        <group group_id="E3">
          <title>Dulaglutide 3.0mg</title>
          <description>Participants received 3.0mg of dulaglutide QW by SC injection.</description>
        </group>
        <group group_id="E4">
          <title>Dulaglutide 4.5mg</title>
          <description>Participants received 4.5mg of dulaglutide QW by SC injection.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 20.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="76"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="81"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="79"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="76"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="76"/>
              </event>
              <event>
                <sub_title>Atrioventricular block second degree</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="76"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="76"/>
              </event>
              <event>
                <sub_title>Pericarditis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="76"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="76"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="76"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="76"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="76"/>
              </event>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="76"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="76"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="76"/>
              </event>
              <event>
                <sub_title>Cholecystitis infective</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="76"/>
              </event>
              <event>
                <sub_title>Fungal oesophagitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="76"/>
              </event>
              <event>
                <sub_title>Peritonsillar abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="76"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Traumatic intracranial haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="76"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperglycaemic hyperosmolar nonketotic syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="76"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="76"/>
              </event>
              <event>
                <sub_title>Hypovolaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="76"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Spinal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="76"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Invasive ductal breast carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="76"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="76"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pulmonary oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="76"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="76"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 20.0</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="29" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="36" subjects_at_risk="81"/>
                <counts group_id="E3" subjects_affected="49" subjects_at_risk="79"/>
                <counts group_id="E4" subjects_affected="39" subjects_at_risk="76"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="79"/>
                <counts group_id="E4" events="10" subjects_affected="4" subjects_at_risk="76"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E4" events="7" subjects_affected="7" subjects_at_risk="76"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="81"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="79"/>
                <counts group_id="E4" events="6" subjects_affected="6" subjects_at_risk="76"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="81"/>
                <counts group_id="E2" events="17" subjects_affected="9" subjects_at_risk="81"/>
                <counts group_id="E3" events="34" subjects_affected="18" subjects_at_risk="79"/>
                <counts group_id="E4" events="32" subjects_affected="16" subjects_at_risk="76"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="10" subjects_affected="6" subjects_at_risk="81"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="79"/>
                <counts group_id="E4" events="13" subjects_affected="8" subjects_at_risk="76"/>
              </event>
              <event>
                <sub_title>Eructation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E4" events="6" subjects_affected="6" subjects_at_risk="76"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="81"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="76"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="81"/>
                <counts group_id="E2" events="45" subjects_affected="18" subjects_at_risk="81"/>
                <counts group_id="E3" events="32" subjects_affected="20" subjects_at_risk="79"/>
                <counts group_id="E4" events="40" subjects_affected="23" subjects_at_risk="76"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="6" subjects_affected="4" subjects_at_risk="81"/>
                <counts group_id="E2" events="20" subjects_affected="9" subjects_at_risk="81"/>
                <counts group_id="E3" events="15" subjects_affected="9" subjects_at_risk="79"/>
                <counts group_id="E4" events="16" subjects_affected="10" subjects_at_risk="76"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="79"/>
                <counts group_id="E4" events="7" subjects_affected="7" subjects_at_risk="76"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="79"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="76"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="79"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="76"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="7" subjects_affected="5" subjects_at_risk="81"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="81"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="79"/>
                <counts group_id="E4" events="4" subjects_affected="3" subjects_at_risk="76"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E2" events="6" subjects_affected="3" subjects_at_risk="81"/>
                <counts group_id="E3" events="6" subjects_affected="5" subjects_at_risk="79"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="76"/>
              </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="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="81"/>
                <counts group_id="E3" events="17" subjects_affected="13" subjects_at_risk="79"/>
                <counts group_id="E4" events="6" subjects_affected="6" subjects_at_risk="76"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="76"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="6" subjects_affected="4" subjects_at_risk="81"/>
                <counts group_id="E2" events="6" subjects_affected="4" subjects_at_risk="81"/>
                <counts group_id="E3" events="6" subjects_affected="5" subjects_at_risk="79"/>
                <counts group_id="E4" events="5" subjects_affected="4" subjects_at_risk="76"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="11" subjects_affected="7" subjects_at_risk="81"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="81"/>
                <counts group_id="E3" events="13" subjects_affected="10" subjects_at_risk="79"/>
                <counts group_id="E4" events="8" subjects_affected="5" subjects_at_risk="76"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="81"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="79"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="76"/>
              </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>
      <email>ClinicalTrials.gov@lilly.com</email>
    </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/NCT02973100
org study id: 16568
secondary id: H9X-MC-GBGJ
secondary id: 2016-002494-34
nct id: NCT02973100
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
The purpose of this study is to evaluate the efficacy and safety of investigational doses of
      dulaglutide in participants with type 2 diabetes on metformin monotherapy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change From Baseline in Hemoglobin A1c (HbA1c)
time frame: Baseline, Week 18
description: HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with baseline as a covariate, pooled country, treatment, time, treatment*time as fixed effects.
measure: Percentage of Participants With HbA1c of <7.0%
time frame: Week 18
description: Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
measure: Change From Baseline in Fasting Serum Glucose (FSG)
time frame: Baseline, Week 18
description: Fasting serum glucose (FSG) is a test to determine how much glucose (sugar) is in a serum sample after an overnight fast. Least Squares (LS) means was determined by MMRM methodology with baseline as a covariate, pooled country, baseline HbA1c strata using >=8% as cutoff, treatment, time, treatment*time as fixed effects.
measure: Change From Baseline in Body Weight
time frame: Baseline, Week 18
description: Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with baseline as a covariate, pooled country, baseline HbA1c strata using >=8% as cutoff, treatment, time, treatment*time as fixed effects.
measure: Percentage of Participants Discontinuing Study Drug Due to Adverse Events
time frame: Baseline through Week 18
description: Adverse event (AE) defined as any unfavorable medical event, newly emerged or a deterioration of a preexisting condition, in other words any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship, that occurred after the visit for informed consent and up to the visit for completion of administration, or discontinuation.
measure: Rate of Documented Symptomatic Hypoglycemia
time frame: Week 18
description: Hypoglycemic events (HE) were classified as severe, documented symptomatic (defined as an HE with typical symptoms of hypoglycemia and a blood glucose level of ≤3.9 millimoles per liter [mmol/L]). Hypoglycemia rate per 30 days was summarized at each visit by treatment group. The rate of hypoglycemia was analyzed using a generalized estimation equations model with a negative binomial distribution and a Log link. LS mean was determined by MMRM methodology with baseline hypoglycemia rate, pooled country, HbA1c at Baseline, treatment, with log of exposure in days divided by 365.25 as the offset.
measure: Pharmacokinetics (PK): The Maximum Drug Concentration at Steady State (Cmax,ss) of Dulaglutide
time frame: 0, 2, 4, 6, 10, 18, 22 weeks and early termination
description: Plasma samples for PK analysis were combined measure obtained from 0, 2, 4, 6, 10, 18, 22 weeks and until early termination of the visit. Cmax takes all time points post dose into account and one value was reported.
measure: Pharmacokinetics: Area Under the Concentration-Time Curve at Steady State From Time Zero to 168 Hours (AUC[0-168], ss) of Dulaglutide
time frame: 0, 2, 4, 6, 10, 18, 22 weeks and early termination
description: AUC[0-168h] is a combined measure obtained from 0, 2, 4, 6, 10, 18, 22 weeks and until early termination of the visit.
arm group label: Dulaglutide 4.5mg
arm group type: Experimental
description: 4.5mg of Dulaglutide administered subcutaneously (SC)
arm group label: Dulaglutide 3.0mg
arm group type: Experimental
description: 3.0mg of Dulaglutide administered SC
arm group label: Dulaglutide 1.5mg
arm group type: Active Comparator
description: 1.5mg of Dulaglutide administered SC
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo administered SC
intervention type: Drug
intervention name: Dulaglutide
description: Administered SC
arm group label: Dulaglutide 1.5mg
arm group label: Dulaglutide 3.0mg
arm group label: Dulaglutide 4.5mg
other name: LY2189265
intervention type: Drug
intervention name: Placebo
description: Administered SC
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Czechia
country: Mexico
country: Poland
country: Puerto Rico
country: Romania
country: United States
country: Czech Republic
url: https://www.lillytrialguide.com/en-US/studies/type-2-diabetes/GBGJ#?postal=
description: A Study of Investigational Dulaglutide Doses in Participants With Type 2 Diabetes on Metformin Monotherapy
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Dulaglutide
sharing ipd: Yes
ipd description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
ipd access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
ipd url: https://vivli.org/
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 