<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/NCT02229396</url>
  </required_header>
  <id_info>
    <org_study_id>D5553C00003</org_study_id>
    <secondary_id>2014-003503-29</secondary_id>
    <nct_id>NCT02229396</nct_id>
  </id_info>
  <brief_title>Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo</brief_title>
  <official_title>A 28-week, Multicenter, Randomized, Double-Blind, Active-Controlled, Phase 3 Study With a 24-week Extension Phase Followed by a 52-week Extension Phase to Evaluate the Efficacy and Safety of Simultaneous Administration of Exenatide Once Weekly 2 mg and Dapagliflozin Once Daily 10 mg Compared to Exenatide Once Weekly 2 mg Alone and Dapagliflozin Once Daily 10 mg Alone in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AstraZeneca</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study D5553C0003 is a 28-week, randomized, double-blind, active-controlled, multicenter,&#xD;
      Phase 3 efficacy and safety study with 24-week and 52-week extension phases of simultaneous&#xD;
      administration of exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg once daily (QD)&#xD;
      compared to EQW 2 mg alone and dapagliflozin 10 mg QD alone in patients with Type 2 diabetes&#xD;
      who have inadequate glycemic control on metformin.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 4, 2014</start_date>
  <completion_date type="Actual">December 28, 2017</completion_date>
  <primary_completion_date type="Actual">April 26, 2016</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in HbA1c From Baseline to Week 28</measure>
    <time_frame>Baseline to Week 28</time_frame>
    <description>To compare the change from baseline to Week 28 in HbA1c between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Body Weight From Baseline to Week 28</measure>
    <time_frame>Baseline to Week 28</time_frame>
    <description>To compare the change from baseline to Week 28 in body weight between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fasting Plasma Glucose From Baseline to Week 28</measure>
    <time_frame>Baseline to Week 28</time_frame>
    <description>To compare the change from baseline to Week 28 in fasting plasma glucose between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 28 in 2-hour Postprandial Glucose After a Standard Meal Tolerance Test</measure>
    <time_frame>Baseline to Week 28</time_frame>
    <description>To compare the change from baseline to Week 28 in 2-hour postprandial glucose after a standard Meal Tolerance Test between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients Achieving Weight Loss ≥5.0% at Week 28</measure>
    <time_frame>Baseline to Week 28</time_frame>
    <description>To compare the percentage of patients achieving weight loss ≥5.0% at 28 weeks between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fasting Plasma Glucose From Baseline to Week 2</measure>
    <time_frame>Baseline to Week 2</time_frame>
    <description>To compare the change from baseline to Week 2 in fasting plasma glucose between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients Achieving HbA1c &lt;7% at Week 28</measure>
    <time_frame>Baseline to Week 28</time_frame>
    <description>To compare the percentage of patients achieving HbA1c &lt;7% at 28 weeks between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Systolic Blood Pressure From Baseline to Week 28</measure>
    <time_frame>Baseline to Week 28</time_frame>
    <description>To compare the change from baseline to Week 28 in systolic blood pressure between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">695</enrollment>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Exenatide Once Weekly 2 mg and Dapagliflozin Once Daily 10 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Exenatide Once Weekly 2 mg Alone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Dapagliflozin Once Daily 10 mg Alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Exantide with Dapagliflozin</intervention_name>
    <description>2 mg weekly suspension injection and 10 mg Dapagliflozin</description>
    <arm_group_label>Exenatide Once Weekly 2 mg and Dapagliflozin Once Daily 10 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Exentide</intervention_name>
    <description>2 mg</description>
    <arm_group_label>Exenatide Once Weekly 2 mg Alone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dapagliflozin</intervention_name>
    <description>10 mg once daily Dapagliflozin</description>
    <arm_group_label>Dapagliflozin Once Daily 10 mg Alone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          -  Has a diagnosis of T2DM.&#xD;
&#xD;
          -  Has HbA1c of 8.0% to 12.0%, inclusive, at Visit 1 and Visit 2.&#xD;
&#xD;
          -  Treated with a stable dose of metformin ≥1500 mg/day for at least 2 months prior to&#xD;
             Screening.&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          -  FPG ≥280 mg/dL (15.6 mmol/L).&#xD;
&#xD;
          -  Serum calcitonin concentration ≥40 pg/mL (≥40 ng/L) at Visit 1 (Screening)&#xD;
&#xD;
          -  Clinically significant abnormal free T4 values or patients needing initiation or&#xD;
             adjustment of thyroid treatment according to the investigator.&#xD;
&#xD;
          -  Abnormal thyroid stimulating hormone (TSH) value at Screening will be further&#xD;
             evaluated by free T4.Patients with clinically significant abnormal free T4 values will&#xD;
             be excluded.&#xD;
&#xD;
          -  Known active proliferative retinopathy.&#xD;
&#xD;
          -  History of, or currently have, acute or chronic pancreatitis, or have triglyceride&#xD;
             concentrations ≥500 mg/dL (≥5.65 mmol/L) at Visit 1&#xD;
&#xD;
          -  History or presence of inflammatory bowel disease or other severe GI diseases,&#xD;
             particularly those which may impact gastric emptying, such as gastroparesis or pyloric&#xD;
             stenosis.&#xD;
&#xD;
          -  History of gastric bypass surgery or gastric banding surgery, or either procedure is&#xD;
             planned during the time period of the study. Current use of gastric balloons is also&#xD;
             excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>130 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Huntsville</city>
        <state>Alabama</state>
        <zip>35801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tuscumbia</city>
        <state>Alabama</state>
        <zip>35674</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Glendale</city>
        <state>Arizona</state>
        <zip>85306</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tempe</city>
        <state>Arizona</state>
        <zip>85283</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chula Vista</city>
        <state>California</state>
        <zip>91911</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>El Cajon</city>
        <state>California</state>
        <zip>92020</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>La Mesa</city>
        <state>California</state>
        <zip>91942</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90807</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Mission Hills</city>
        <state>California</state>
        <zip>91345</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Montclair</city>
        <state>California</state>
        <zip>91763</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Oceanside</city>
        <state>California</state>
        <zip>92056</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tustin</city>
        <state>California</state>
        <zip>92780</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Van Nuys</city>
        <state>California</state>
        <zip>91405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Boynton Beach</city>
        <state>Florida</state>
        <zip>33437</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33765</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <zip>33134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33316</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32256</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32277</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33126</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33133</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33135</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33142</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33165</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33175</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33186</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>North Miami Beach</city>
        <state>Florida</state>
        <zip>33162</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33603</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Williston</city>
        <state>Florida</state>
        <zip>32696</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Avon</city>
        <state>Indiana</state>
        <zip>46123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Evansville</city>
        <state>Indiana</state>
        <zip>47714</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Franklin</city>
        <state>Indiana</state>
        <zip>46131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Muncie</city>
        <state>Indiana</state>
        <zip>47304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Newton</city>
        <state>Kansas</state>
        <zip>67114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Monroe</city>
        <state>Louisiana</state>
        <zip>71201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hazelwood</city>
        <state>Missouri</state>
        <zip>63042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bellevue</city>
        <state>Nebraska</state>
        <zip>68005</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Haddon Heights</city>
        <state>New Jersey</state>
        <zip>08035</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Burlington</city>
        <state>North Carolina</state>
        <zip>27215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Greensboro</city>
        <state>North Carolina</state>
        <zip>27408</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Mooresville</city>
        <state>North Carolina</state>
        <zip>28117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Morehead City</city>
        <state>North Carolina</state>
        <zip>28557</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Vandalia</city>
        <state>Ohio</state>
        <zip>45377</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Medford</city>
        <state>Oregon</state>
        <zip>97504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>91307</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Greer</city>
        <state>South Carolina</state>
        <zip>29651</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Spartanburg</city>
        <state>South Carolina</state>
        <zip>29303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Summerville</city>
        <state>South Carolina</state>
        <zip>29485</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Dakota Dunes</city>
        <state>South Dakota</state>
        <zip>57049</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77074</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77079</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77090</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Pearland</city>
        <state>Texas</state>
        <zip>77584</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tomball</city>
        <state>Texas</state>
        <zip>77375</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Clinton</city>
        <state>Utah</state>
        <zip>84015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Burke</city>
        <state>Virginia</state>
        <zip>22015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Manassas</city>
        <state>Virginia</state>
        <zip>20110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Baja</city>
        <zip>6500</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Balatonfüred</city>
        <zip>8230</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Budapest</city>
        <zip>1033</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Budapest</city>
        <zip>1083</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Budapest</city>
        <zip>1088</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Budaörs</city>
        <zip>2040</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Debrecen</city>
        <zip>4025</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Eger</city>
        <zip>3300</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Godollo</city>
        <zip>2100</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Gyula</city>
        <zip>5700</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Gödöllő</city>
        <zip>2100</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kecskemét</city>
        <zip>6000</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Komárom</city>
        <zip>2921</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Létavértes</city>
        <zip>4281</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nyíregyháza</city>
        <zip>4405</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Pécs</city>
        <zip>7623</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Szeged</city>
        <zip>6722</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Szekszárd</city>
        <zip>7100</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lodz</city>
        <zip>94-255</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lublin</city>
        <zip>20-538</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Oświęcim</city>
        <zip>32-600</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Parczew</city>
        <zip>21-200</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Poznań</city>
        <zip>61-655</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Torun</city>
        <zip>87-100</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Zgierz</city>
        <zip>95-100</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Łódź</city>
        <zip>94-048</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Baia Mare</city>
        <zip>430222</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bucuresti</city>
        <zip>010192</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bucuresti</city>
        <zip>010825</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bucuresti</city>
        <zip>020475</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Galati</city>
        <zip>800578</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Oradea</city>
        <zip>410032</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Oradea</city>
        <zip>410169</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Oradea</city>
        <zip>410469</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ploiesti</city>
        <zip>100342</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Timișoara</city>
        <zip>300456</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Banska Bystrica</city>
        <zip>97517</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bardejov</city>
        <zip>085 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bratislava</city>
        <zip>81108</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bratislava</city>
        <zip>82106</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bratislava</city>
        <zip>85101</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Dolny Kubin</city>
        <zip>026 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kosice</city>
        <zip>04001</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Levice</city>
        <zip>934 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Levice</city>
        <zip>93401</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lucenec</city>
        <zip>984 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nitra</city>
        <zip>94911</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Pezinok</city>
        <zip>90201</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sturovo</city>
        <zip>943 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Trebišov</city>
        <zip>07501</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bloemfontein</city>
        <zip>9301</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Cape Town</city>
        <zip>7925</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Johannesburg</city>
        <zip>1818</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kempton Park</city>
        <zip>1619</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Middelburg</city>
        <zip>1055</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Parow</city>
        <zip>7505</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Port Elizabeth</city>
        <zip>6014</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Pretoria</city>
        <zip>0001</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hungary</country>
    <country>Poland</country>
    <country>Romania</country>
    <country>Slovakia</country>
    <country>South Africa</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&amp;studyid=3057&amp;filename=d5553c00003_revised_csp_3_Redacted.pdf</url>
    <description>CSP_radacted</description>
  </link>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>August 28, 2014</study_first_submitted>
  <study_first_submitted_qc>August 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 1, 2014</study_first_posted>
  <results_first_submitted>August 9, 2017</results_first_submitted>
  <results_first_submitted_qc>August 9, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">September 8, 2017</results_first_posted>
  <last_update_submitted>December 6, 2018</last_update_submitted>
  <last_update_submitted_qc>December 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 31, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Diabetes Mellitus</keyword>
  <keyword>Exenatide</keyword>
  <keyword>Dapagliflozin</keyword>
  <keyword>Diabetes medication</keyword>
  <keyword>Treatment efficacy</keyword>
  <keyword>Placebo</keyword>
  <keyword>Metabolism</keyword>
  <keyword>Cardiovascular metabolic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dapagliflozin</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Study conducted between 04 September 2014 and 28 December 2017. 118 centers in 6 countries randomized patients in the study. A Primary Analysis was performed following completion of the 28-week Treatment Period with a data cut-off date of 26 April 2016. All Primary and Secondary Outcome measures were reported at the time of the Primary Analysis.</recruitment_details>
      <pre_assignment_details>The study had a Screening Visit, a 1-week placebo Lead-in Period, a Randomization Visit, and 9 further visits at 1- to 4-week intervals during a 28-week Treatment Period. Patients then entered a 24-week Extension Period 1 and subsequent 52-week Extension Period 2. A follow-up visit occurred 10 weeks after last dose of study medication.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Dapagliflozin + Placebo</title>
          <description>Dapagliflozin 10 milligram (mg) tablet administered orally once daily + matching placebo for exenatide administered as subcutaneous (SC) injection once weekly. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.</description>
        </group>
        <group group_id="P2">
          <title>Exenatide + Dapagliflozin</title>
          <description>Exenatide once weekly (EQW) 2 mg administered as SC injection + dapagliflozin 10 mg tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.</description>
        </group>
        <group group_id="P3">
          <title>Exenatide + Placebo</title>
          <description>Exenatide once weekly (EQW) 2 mg administered as SC injection + matching placebo for dapagliflozin tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="233"/>
                <participants group_id="P2" count="231"/>
                <participants group_id="P3" count="231"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Randomization Code Allocated</title>
              <participants_list>
                <participants group_id="P1" count="233"/>
                <participants group_id="P2" count="231"/>
                <participants group_id="P3" count="231"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Analysis Set</title>
              <participants_list>
                <participants group_id="P1" count="233"/>
                <participants group_id="P2" count="231"/>
                <participants group_id="P3" count="230"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Intent-to-Treat (ITT) Analysis Set</title>
              <participants_list>
                <participants group_id="P1" count="230"/>
                <participants group_id="P2" count="228"/>
                <participants group_id="P3" count="227"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed 28-Week Study Period</title>
              <participants_list>
                <participants group_id="P1" count="208"/>
                <participants group_id="P2" count="202"/>
                <participants group_id="P3" count="193"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed 52-Week Study Period</title>
              <participants_list>
                <participants group_id="P1" count="194"/>
                <participants group_id="P2" count="193"/>
                <participants group_id="P3" count="177"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="155"/>
                <participants group_id="P2" count="154"/>
                <participants group_id="P3" count="136"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="78"/>
                <participants group_id="P2" count="77"/>
                <participants group_id="P3" count="95"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="12"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="14"/>
                <participants group_id="P3" count="21"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Patient Incorrectly Randomized</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="18"/>
                <participants group_id="P3" count="15"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
                <participants group_id="P2" count="28"/>
                <participants group_id="P3" count="41"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study-Specific Withdrawal Criteria</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrew; No Record on Termination Page</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The overall number of baseline participants is comprised of the ITT analysis set, defined as all randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline hemoglobin A1c (HbA1c) assessment.</population>
      <group_list>
        <group group_id="B1">
          <title>Dapagliflozin + Placebo</title>
          <description>Dapagliflozin 10 mg tablet administered orally once daily + matching placebo for exenatide administered as SC injection once weekly. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.</description>
        </group>
        <group group_id="B2">
          <title>Exenatide + Dapagliflozin</title>
          <description>Exenatide once weekly (EQW) 2 mg administered as SC injection + dapagliflozin 10 mg tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.</description>
        </group>
        <group group_id="B3">
          <title>Exenatide + Placebo</title>
          <description>Exenatide once weekly (EQW) 2 mg administered as SC injection + matching placebo for dapagliflozin tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.</description>
        </group>
        <group group_id="B4">
          <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="230"/>
            <count group_id="B2" value="228"/>
            <count group_id="B3" value="227"/>
            <count group_id="B4" value="685"/>
          </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="54.5" spread="9.16" lower_limit="28" upper_limit="75"/>
                    <measurement group_id="B2" value="53.8" spread="9.82" lower_limit="26" upper_limit="80"/>
                    <measurement group_id="B3" value="54.2" spread="9.62" lower_limit="29" upper_limit="80"/>
                    <measurement group_id="B4" value="54.2" spread="9.53" lower_limit="26" upper_limit="80"/>
                  </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="120"/>
                    <measurement group_id="B2" value="126"/>
                    <measurement group_id="B3" value="111"/>
                    <measurement group_id="B4" value="357"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="110"/>
                    <measurement group_id="B2" value="102"/>
                    <measurement group_id="B3" value="116"/>
                    <measurement group_id="B4" value="328"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>American Indian Or Alaska Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black Or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="27"/>
                    <measurement group_id="B4" value="94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="189"/>
                    <measurement group_id="B2" value="190"/>
                    <measurement group_id="B3" value="194"/>
                    <measurement group_id="B4" value="573"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in HbA1c From Baseline to Week 28</title>
        <description>To compare the change from baseline to Week 28 in HbA1c between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.</description>
        <time_frame>Baseline to Week 28</time_frame>
        <population>The ITT analysis set included all randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin + Placebo</title>
            <description>Dapagliflozin 10 mg tablet administered orally once daily + matching placebo for exenatide administered as SC injection once weekly. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.</description>
          </group>
          <group group_id="O2">
            <title>Exenatide + Dapagliflozin</title>
            <description>Exenatide once weekly (EQW) 2 mg administered as SC injection + dapagliflozin 10 mg tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.</description>
          </group>
          <group group_id="O3">
            <title>Exenatide + Placebo</title>
            <description>Exenatide once weekly (EQW) 2 mg administered as SC injection + matching placebo for dapagliflozin tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in HbA1c From Baseline to Week 28</title>
          <description>To compare the change from baseline to Week 28 in HbA1c between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.</description>
          <population>The ITT analysis set included all randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.</population>
          <units>% HbA1c</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="230"/>
                <count group_id="O2" value="228"/>
                <count group_id="O3" value="227"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.39" lower_limit="-1.57" upper_limit="-1.21"/>
                    <measurement group_id="O2" value="-1.98" lower_limit="-2.16" upper_limit="-1.79"/>
                    <measurement group_id="O3" value="-1.60" lower_limit="-1.79" upper_limit="-1.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.003</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Treatment, region, baseline HbA1c stratum (&lt;9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.38</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.129</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.63</ci_lower_limit>
            <ci_upper_limit>-0.13</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Treatment, region, baseline HbA1c stratum (&lt;9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.59</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.127</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.84</ci_lower_limit>
            <ci_upper_limit>-0.34</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Body Weight From Baseline to Week 28</title>
        <description>To compare the change from baseline to Week 28 in body weight between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.</description>
        <time_frame>Baseline to Week 28</time_frame>
        <population>The ITT analysis set included all randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin + Placebo</title>
            <description>Dapagliflozin 10 mg tablet administered orally once daily + matching placebo for exenatide administered as SC injection once weekly. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.</description>
          </group>
          <group group_id="O2">
            <title>Exenatide + Dapagliflozin</title>
            <description>Exenatide once weekly (EQW) 2 mg administered as SC injection + dapagliflozin 10 mg tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.</description>
          </group>
          <group group_id="O3">
            <title>Exenatide + Placebo</title>
            <description>Exenatide once weekly (EQW) 2 mg administered as SC injection + matching placebo for dapagliflozin tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Body Weight From Baseline to Week 28</title>
          <description>To compare the change from baseline to Week 28 in body weight between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.</description>
          <population>The ITT analysis set included all randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.</population>
          <units>kilogram</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="230"/>
                <count group_id="O2" value="228"/>
                <count group_id="O3" value="227"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.22" lower_limit="-2.78" upper_limit="-1.66"/>
                    <measurement group_id="O2" value="-3.55" lower_limit="-4.12" upper_limit="-2.99"/>
                    <measurement group_id="O3" value="-1.56" lower_limit="-2.13" upper_limit="-0.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Treatment, region, baseline HbA1c stratum (&lt;9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-2.00</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.406</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.79</ci_lower_limit>
            <ci_upper_limit>-1.20</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Treatment, region, baseline HbA1c stratum (&lt;9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.33</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.400</dispersion_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>-0.55</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Fasting Plasma Glucose From Baseline to Week 28</title>
        <description>To compare the change from baseline to Week 28 in fasting plasma glucose between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.</description>
        <time_frame>Baseline to Week 28</time_frame>
        <population>The ITT analysis set included all randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin + Placebo</title>
            <description>Dapagliflozin 10 mg tablet administered orally once daily + matching placebo for exenatide administered as SC injection once weekly. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.</description>
          </group>
          <group group_id="O2">
            <title>Exenatide + Dapagliflozin</title>
            <description>Exenatide once weekly (EQW) 2 mg administered as SC injection + dapagliflozin 10 mg tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.</description>
          </group>
          <group group_id="O3">
            <title>Exenatide + Placebo</title>
            <description>Exenatide once weekly (EQW) 2 mg administered as SC injection + matching placebo for dapagliflozin tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Fasting Plasma Glucose From Baseline to Week 28</title>
          <description>To compare the change from baseline to Week 28 in fasting plasma glucose between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.</description>
          <population>The ITT analysis set included all randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.</population>
          <units>milligrams/deciliter (mg/dL)</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="230"/>
                <count group_id="O2" value="228"/>
                <count group_id="O3" value="227"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-49.19" lower_limit="-54.91" upper_limit="-43.47"/>
                    <measurement group_id="O2" value="-65.83" lower_limit="-71.60" upper_limit="-60.06"/>
                    <measurement group_id="O3" value="-45.75" lower_limit="-51.67" upper_limit="-39.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Treatment, region, baseline HbA1c stratum (&lt;9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-20.08</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>4.007</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-27.95</ci_lower_limit>
            <ci_upper_limit>-12.20</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Treatment, region, baseline HbA1c stratum (&lt;9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-16.64</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.947</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-24.39</ci_lower_limit>
            <ci_upper_limit>-8.89</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 28 in 2-hour Postprandial Glucose After a Standard Meal Tolerance Test</title>
        <description>To compare the change from baseline to Week 28 in 2-hour postprandial glucose after a standard Meal Tolerance Test between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.</description>
        <time_frame>Baseline to Week 28</time_frame>
        <population>The ITT analysis set included all randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin + Placebo</title>
            <description>Dapagliflozin 10 mg tablet administered orally once daily + matching placebo for exenatide administered as SC injection once weekly. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.</description>
          </group>
          <group group_id="O2">
            <title>Exenatide + Dapagliflozin</title>
            <description>Exenatide once weekly (EQW) 2 mg administered as SC injection + dapagliflozin 10 mg tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.</description>
          </group>
          <group group_id="O3">
            <title>Exenatide + Placebo</title>
            <description>Exenatide once weekly (EQW) 2 mg administered as SC injection + matching placebo for dapagliflozin tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 28 in 2-hour Postprandial Glucose After a Standard Meal Tolerance Test</title>
          <description>To compare the change from baseline to Week 28 in 2-hour postprandial glucose after a standard Meal Tolerance Test between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.</description>
          <population>The ITT analysis set included all randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.</population>
          <units>mg/dL</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="230"/>
                <count group_id="O2" value="228"/>
                <count group_id="O3" value="227"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-61.05" lower_limit="-69.10" upper_limit="-53.00"/>
                    <measurement group_id="O2" value="-87.83" lower_limit="-95.83" upper_limit="-79.84"/>
                    <measurement group_id="O3" value="-60.09" lower_limit="-68.48" upper_limit="-51.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <method_desc>Treatment, region, and baseline HbA1c stratum (&lt;9.0% or ≥9.0%), as fixed factors; baseline value as covariate.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-27.74</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>5.168</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-37.89</ci_lower_limit>
            <ci_upper_limit>-17.59</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <method_desc>Treatment, region, and baseline HbA1c stratum (&lt;9.0% or ≥9.0%), as fixed factors; baseline value as covariate.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-26.78</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>5.090</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-36.78</ci_lower_limit>
            <ci_upper_limit>-16.78</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients Achieving Weight Loss ≥5.0% at Week 28</title>
        <description>To compare the percentage of patients achieving weight loss ≥5.0% at 28 weeks between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.</description>
        <time_frame>Baseline to Week 28</time_frame>
        <population>The ITT analysis set included all randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin + Placebo</title>
            <description>Dapagliflozin 10 mg tablet administered orally once daily + matching placebo for exenatide administered as SC injection once weekly. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.</description>
          </group>
          <group group_id="O2">
            <title>Exenatide + Dapagliflozin</title>
            <description>Exenatide once weekly (EQW) 2 mg administered as SC injection + dapagliflozin 10 mg tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.</description>
          </group>
          <group group_id="O3">
            <title>Exenatide + Placebo</title>
            <description>Exenatide once weekly (EQW) 2 mg administered as SC injection + matching placebo for dapagliflozin tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients Achieving Weight Loss ≥5.0% at Week 28</title>
          <description>To compare the percentage of patients achieving weight loss ≥5.0% at 28 weeks between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.</description>
          <population>The ITT analysis set included all randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.</population>
          <units>% of patients</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="230"/>
                <count group_id="O2" value="228"/>
                <count group_id="O3" value="227"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.0" lower_limit="14.8" upper_limit="25.2"/>
                    <measurement group_id="O2" value="33.3" lower_limit="27.2" upper_limit="39.5"/>
                    <measurement group_id="O3" value="13.7" lower_limit="9.2" upper_limit="18.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Stratified by baseline HbA1c (&lt;9.0% or ≥9.0%).</method_desc>
            <param_type>Difference in percentages</param_type>
            <param_value>19.7</param_value>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Stratified by baseline HbA1c (&lt;9.0% or ≥9.0%).</method_desc>
            <param_type>Difference in percentages</param_type>
            <param_value>13.3</param_value>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Fasting Plasma Glucose From Baseline to Week 2</title>
        <description>To compare the change from baseline to Week 2 in fasting plasma glucose between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.</description>
        <time_frame>Baseline to Week 2</time_frame>
        <population>The ITT analysis set included all randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin + Placebo</title>
            <description>Dapagliflozin 10 mg tablet administered orally once daily + matching placebo for exenatide administered as SC injection once weekly. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.</description>
          </group>
          <group group_id="O2">
            <title>Exenatide + Dapagliflozin</title>
            <description>Exenatide once weekly (EQW) 2 mg administered as SC injection + dapagliflozin 10 mg tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.</description>
          </group>
          <group group_id="O3">
            <title>Exenatide + Placebo</title>
            <description>Exenatide once weekly (EQW) 2 mg administered as SC injection + matching placebo for dapagliflozin tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Fasting Plasma Glucose From Baseline to Week 2</title>
          <description>To compare the change from baseline to Week 2 in fasting plasma glucose between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.</description>
          <population>The ITT analysis set included all randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.</population>
          <units>mg/dL</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="230"/>
                <count group_id="O2" value="228"/>
                <count group_id="O3" value="227"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-26.31" lower_limit="-31.42" upper_limit="-21.20"/>
                    <measurement group_id="O2" value="-41.34" lower_limit="-46.48" upper_limit="-36.20"/>
                    <measurement group_id="O3" value="-21.08" lower_limit="-26.29" upper_limit="-15.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Treatment, region, baseline HbA1c stratum (&lt;9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-20.26</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.494</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-27.12</ci_lower_limit>
            <ci_upper_limit>-13.40</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>This is a nominal p-value.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Treatment, region, baseline HbA1c stratum (&lt;9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-15.03</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.477</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-21.85</ci_lower_limit>
            <ci_upper_limit>-8.20</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients Achieving HbA1c &lt;7% at Week 28</title>
        <description>To compare the percentage of patients achieving HbA1c &lt;7% at 28 weeks between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.</description>
        <time_frame>Baseline to Week 28</time_frame>
        <population>The ITT analysis set included all randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin + Placebo</title>
            <description>Dapagliflozin 10 mg tablet administered orally once daily + matching placebo for exenatide administered as SC injection once weekly. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.</description>
          </group>
          <group group_id="O2">
            <title>Exenatide + Dapagliflozin</title>
            <description>Exenatide once weekly (EQW) 2 mg administered as SC injection + dapagliflozin 10 mg tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.</description>
          </group>
          <group group_id="O3">
            <title>Exenatide + Placebo</title>
            <description>Exenatide once weekly (EQW) 2 mg administered as SC injection + matching placebo for dapagliflozin tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients Achieving HbA1c &lt;7% at Week 28</title>
          <description>To compare the percentage of patients achieving HbA1c &lt;7% at 28 weeks between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.</description>
          <population>The ITT analysis set included all randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.</population>
          <units>% of patients</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="230"/>
                <count group_id="O2" value="228"/>
                <count group_id="O3" value="227"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.1" lower_limit="14.1" upper_limit="24.2"/>
                    <measurement group_id="O2" value="44.7" lower_limit="38.3" upper_limit="51.2"/>
                    <measurement group_id="O3" value="26.9" lower_limit="21.1" upper_limit="32.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Stratified by baseline HbA1c (&lt;9.0% or ≥9.0%).</method_desc>
            <param_type>Difference in percentages</param_type>
            <param_value>17.9</param_value>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Stratified by baseline HbA1c (&lt;9.0% or ≥9.0%).</method_desc>
            <param_type>Difference in percentages</param_type>
            <param_value>25.6</param_value>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Systolic Blood Pressure From Baseline to Week 28</title>
        <description>To compare the change from baseline to Week 28 in systolic blood pressure between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.</description>
        <time_frame>Baseline to Week 28</time_frame>
        <population>The ITT analysis set included all randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Dapagliflozin + Placebo</title>
            <description>Dapagliflozin 10 mg tablet administered orally once daily + matching placebo for exenatide administered as SC injection once weekly. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.</description>
          </group>
          <group group_id="O2">
            <title>Exenatide + Dapagliflozin</title>
            <description>Exenatide once weekly (EQW) 2 mg administered as SC injection + dapagliflozin 10 mg tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.</description>
          </group>
          <group group_id="O3">
            <title>Exenatide + Placebo</title>
            <description>Exenatide once weekly (EQW) 2 mg administered as SC injection + matching placebo for dapagliflozin tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Systolic Blood Pressure From Baseline to Week 28</title>
          <description>To compare the change from baseline to Week 28 in systolic blood pressure between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.</description>
          <population>The ITT analysis set included all randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.</population>
          <units>millimeters of mercury (mmHg)</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="230"/>
                <count group_id="O2" value="228"/>
                <count group_id="O3" value="227"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.8" lower_limit="-3.4" upper_limit="-0.3"/>
                    <measurement group_id="O2" value="-4.3" lower_limit="-5.8" upper_limit="-2.7"/>
                    <measurement group_id="O3" value="-1.2" lower_limit="-2.8" upper_limit="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.005</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Treatment, region, baseline HbA1c stratum (&lt;9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-3.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.08</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.2</ci_lower_limit>
            <ci_upper_limit>-0.9</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.022</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Treatment, region, baseline HbA1c stratum (&lt;9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-2.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.06</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.5</ci_lower_limit>
            <ci_upper_limit>-0.4</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From baseline (Day 1) up to Week 104 (28-week Treatment Period + 24-week Extension Period 1 + 52-week Extension Period 2).</time_frame>
      <desc>Treatment-emergent adverse event data is reported for the Safety Analysis set defined as all randomized patients receiving at least 1 dose of study medication. One patient who was randomized did not receive study medication (the patient was randomized in error); this patient was not counted as completing or discontinuing treatment.</desc>
      <group_list>
        <group group_id="E1">
          <title>Dapagliflozin + Placebo</title>
          <description>Dapagliflozin 10 mg tablet administered orally once daily + matching placebo for exenatide administered as SC injection once weekly. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.</description>
        </group>
        <group group_id="E2">
          <title>Exenatide + Dapagliflozin</title>
          <description>Exenatide once weekly (EQW) 2 mg administered as SC injection + dapagliflozin 10 mg tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.</description>
        </group>
        <group group_id="E3">
          <title>Exenatide + Placebo</title>
          <description>Exenatide once weekly (EQW) 2 mg administered as SC injection + matching placebo for dapagliflozin tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 20.1</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="2" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="231"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="230"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="231"/>
                <counts group_id="E3" subjects_affected="18" subjects_at_risk="230"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="230"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="230"/>
              </event>
              <event>
                <sub_title>Arteriosclerosis coronary artery</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="230"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="230"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="230"/>
              </event>
              <event>
                <sub_title>Coronary artery occlusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="230"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="230"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="230"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="230"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Tinnitus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="230"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Pituitary-dependent Cushing's syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="230"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain lower</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="230"/>
              </event>
              <event>
                <sub_title>Anal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="230"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="230"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="230"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="230"/>
              </event>
              <event>
                <sub_title>Pancreatic necrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="230"/>
              </event>
              <event>
                <sub_title>Umbilical hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="230"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="230"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="230"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Biliary dyskinesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="230"/>
              </event>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="230"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="231"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="230"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaphylactic reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="230"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="230"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="230"/>
              </event>
              <event>
                <sub_title>Meningitis viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="230"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="230"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="230"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="230"/>
              </event>
              <event>
                <sub_title>Splenic rupture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="230"/>
              </event>
              <event>
                <sub_title>Multiple injuries</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="230"/>
              </event>
              <event>
                <sub_title>Spinal compression fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="230"/>
              </event>
              <event>
                <sub_title>Toxicity to various agents</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="230"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="230"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="230"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="230"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Exostosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="230"/>
              </event>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="230"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="230"/>
              </event>
              <event>
                <sub_title>Periarthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="230"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Adenocarcinoma of colon</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="230"/>
              </event>
              <event>
                <sub_title>Lipoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="230"/>
              </event>
              <event>
                <sub_title>Pancreatic carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="230"/>
              </event>
              <event>
                <sub_title>Renal neoplasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="230"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic neuropathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="230"/>
              </event>
              <event>
                <sub_title>Haemorrhagic stroke</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="230"/>
              </event>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="230"/>
              </event>
              <event>
                <sub_title>Optic neuritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="230"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="230"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="230"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="230"/>
              </event>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="230"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Hydronephrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="230"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="230"/>
              </event>
              <event>
                <sub_title>Interstitial lung disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="230"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="230"/>
              </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="233"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="230"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="230"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 20.1</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="73" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="87" subjects_at_risk="231"/>
                <counts group_id="E3" subjects_affected="78" subjects_at_risk="230"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="14" subjects_affected="11" subjects_at_risk="233"/>
                <counts group_id="E2" events="17" subjects_affected="13" subjects_at_risk="231"/>
                <counts group_id="E3" events="25" subjects_affected="17" subjects_at_risk="230"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="12" subjects_affected="10" subjects_at_risk="233"/>
                <counts group_id="E2" events="14" subjects_affected="13" subjects_at_risk="231"/>
                <counts group_id="E3" events="29" subjects_affected="26" subjects_at_risk="230"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="233"/>
                <counts group_id="E2" events="10" subjects_affected="8" subjects_at_risk="231"/>
                <counts group_id="E3" events="15" subjects_affected="12" subjects_at_risk="230"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection site nodule</sub_title>
                <counts group_id="E1" events="22" subjects_affected="13" subjects_at_risk="233"/>
                <counts group_id="E2" events="40" subjects_affected="20" subjects_at_risk="231"/>
                <counts group_id="E3" events="24" subjects_affected="14" subjects_at_risk="230"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="15" subjects_affected="12" subjects_at_risk="233"/>
                <counts group_id="E2" events="17" subjects_affected="15" subjects_at_risk="231"/>
                <counts group_id="E3" events="10" subjects_affected="8" subjects_at_risk="230"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="25" subjects_affected="22" subjects_at_risk="233"/>
                <counts group_id="E2" events="22" subjects_affected="15" subjects_at_risk="231"/>
                <counts group_id="E3" events="29" subjects_affected="17" subjects_at_risk="230"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="23" subjects_affected="16" subjects_at_risk="233"/>
                <counts group_id="E2" events="31" subjects_affected="19" subjects_at_risk="231"/>
                <counts group_id="E3" events="24" subjects_affected="15" subjects_at_risk="230"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="233"/>
                <counts group_id="E2" events="18" subjects_affected="16" subjects_at_risk="231"/>
                <counts group_id="E3" events="12" subjects_affected="12" subjects_at_risk="230"/>
              </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>At least 30 days prior to submission for publication or presentation, Authors shall provide Sponsor with such material for its review. Sponsor shall have 30 days to comment. If requested by Sponsor, Authors shall withhold material for an additional 90 days to allow for the taking of measures to establish its proprietary rights. No publication or presentation shall be made unless and until any information determined at Sponsor's sole discretion to be Confidential has been removed.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Global Clinical Leader</name_or_title>
      <organization>AstraZeneca</organization>
      <phone>+1 302 885 1180</phone>
      <email>ClinicalTrialTransparency@astrazeneca.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/NCT02229396
org study id: D5553C00003
secondary id: 2014-003503-29
nct id: NCT02229396
lead sponsor: 
has dmc: No
Study D5553C0003 is a 28-week, randomized, double-blind, active-controlled, multicenter,
      Phase 3 efficacy and safety study with 24-week and 52-week extension phases of simultaneous
      administration of exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg once daily (QD)
      compared to EQW 2 mg alone and dapagliflozin 10 mg QD alone in patients with Type 2 diabetes
      who have inadequate glycemic control on metformin.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change in HbA1c From Baseline to Week 28
time frame: Baseline to Week 28
description: To compare the change from baseline to Week 28 in HbA1c between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.
measure: Change in Body Weight From Baseline to Week 28
time frame: Baseline to Week 28
description: To compare the change from baseline to Week 28 in body weight between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.
measure: Change in Fasting Plasma Glucose From Baseline to Week 28
time frame: Baseline to Week 28
description: To compare the change from baseline to Week 28 in fasting plasma glucose between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.
measure: Change From Baseline to Week 28 in 2-hour Postprandial Glucose After a Standard Meal Tolerance Test
time frame: Baseline to Week 28
description: To compare the change from baseline to Week 28 in 2-hour postprandial glucose after a standard Meal Tolerance Test between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.
measure: Percentage of Patients Achieving Weight Loss ≥5.0% at Week 28
time frame: Baseline to Week 28
description: To compare the percentage of patients achieving weight loss ≥5.0% at 28 weeks between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.
measure: Change in Fasting Plasma Glucose From Baseline to Week 2
time frame: Baseline to Week 2
description: To compare the change from baseline to Week 2 in fasting plasma glucose between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.
measure: Percentage of Patients Achieving HbA1c <7% at Week 28
time frame: Baseline to Week 28
description: To compare the percentage of patients achieving HbA1c <7% at 28 weeks between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.
measure: Change in Systolic Blood Pressure From Baseline to Week 28
time frame: Baseline to Week 28
description: To compare the change from baseline to Week 28 in systolic blood pressure between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.
arm group label: Exenatide Once Weekly 2 mg and Dapagliflozin Once Daily 10 mg
arm group type: Experimental
arm group label: Exenatide Once Weekly 2 mg Alone
arm group type: Experimental
arm group label: Dapagliflozin Once Daily 10 mg Alone
arm group type: Active Comparator
intervention type: Drug
intervention name: Exantide with Dapagliflozin
description: 2 mg weekly suspension injection and 10 mg Dapagliflozin
arm group label: Exenatide Once Weekly 2 mg and Dapagliflozin Once Daily 10 mg
intervention type: Drug
intervention name: Exentide
description: 2 mg
arm group label: Exenatide Once Weekly 2 mg Alone
intervention type: Drug
intervention name: Dapagliflozin
description: 10 mg once daily Dapagliflozin
arm group label: Dapagliflozin Once Daily 10 mg Alone
criteria: 
gender: All
minimum age: 18 Years
maximum age: 130 Years
healthy volunteers: No
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country: Hungary
country: Poland
country: Romania
country: Slovakia
country: South Africa
country: United States
url: http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=3057&filename=d5553c00003_revised_csp_3_Redacted.pdf
description: CSP_radacted
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Dapagliflozin
participant flow: 
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certain agreements: 
point of contact: 