<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/NCT01733758</url>
  </required_header>
  <id_info>
    <org_study_id>113121</org_study_id>
    <nct_id>NCT01733758</nct_id>
  </id_info>
  <brief_title>A Monotherapy Study to Evaluate the Efficacy and Safety of 2 Dose Levels of Albiglutide in Japanese Subjects With Type 2 Diabetes Mellitus (T2DM)</brief_title>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Monotherapy Study to Determine the Efficacy and Safety of 2 Dose Levels of Albiglutide in Subjects With Type 2 Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to examine the efficacy and safety of 2 dose levels of weekly&#xD;
      subcutaneously injected albiglutide compared with placebo and an open label reference arm of&#xD;
      daily subcutaneous injections of liraglutide, in Japanese subjects with Type 2 diabetes&#xD;
      mellitus.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2013</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">June 2014</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>Model-adjusted Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24</measure>
    <time_frame>Baseline and Week 24</time_frame>
    <description>HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. The Baseline HbA1c value is defined as the last nonmissing value before the start of treatment. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. Based on analysis of covariance (ANCOVA): Change at Week 24 = treatment (placebo, albiglutide 30 mg, albiglutide 50 mg) + Baseline HbA1c + prior diabetes therapy + age category (&lt;65 years versus ≥65 years). Participants who discontinued from study treatment before Week 24 had their last post-Baseline HbA1c carried forward for the analysis unless the value is past 14 days after the last dose of study drug. The open-label liraglutide group was a reference group and not included in the primary endpoint analysis model. Descriptive summary statistics are provided as a separate outcome measure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean HbA1c at Baseline, Week 24, and Change From Baseline at Week 24</measure>
    <time_frame>Baseline and Week 24</time_frame>
    <description>HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. The Baseline HbA1c value is defined as the last nonmissing value before the start of treatment. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. Participants who discontinued from study treatment before Week 24 had their last post-Baseline HbA1c value carried forward for the summary, unless the value was past 14 days after the last dose of study drug. The open-label liraglutide group was a reference group; descriptive statistics comparing albiglutide and liraglutide were exploratory endpoints.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in HbA1c at Week 52</measure>
    <time_frame>Baseline and Week 52</time_frame>
    <description>HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3- month period. The Baseline HbA1c value is defined as the last non-missing value on or before the start of treatment. Change from Baseline was calculated as the value at Week 52 minus the value at Baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of &lt;6.5% and &lt;7.0%) at Week 24</measure>
    <time_frame>Week 24</time_frame>
    <description>HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. Clinically meaningful levels of response in HbA1c are defined as &lt;6.5% and &lt;7.0%. Participants who discontinued the study before Week 24 had their last post-Baseline HbA1c value carried forwrad for the summary unless the value was past 14 days after the last dose of study drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of &lt;6.5% and &lt;7.0%) at Week 52</measure>
    <time_frame>Week 52</time_frame>
    <description>HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. Clinically meaningful levels of response in HbA1c are defined as &lt;6.5% and &lt;7.0%.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24</measure>
    <time_frame>Baseline and Week 24</time_frame>
    <description>FPG is an indicator of efficacy. The Baseline FPG value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the FPG value at Week 24 minus the FPG value at Baseline. Participants who discontinued from study treatment before Week 24 had their last post-Baseline FPG observation carried forward for the summary unless the value was 14 days past the last dose of study drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52</measure>
    <time_frame>Baseline and Week 52</time_frame>
    <description>FPG is an indicator of efficacy. The Baseline FPG value is defined as the last non-missing value on or before the start of treatment. Change from Baseline was calculated as the FPG value at Week 52 minus the FPG value at Baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Body Weight at Week 24</measure>
    <time_frame>Baseline and Week 24</time_frame>
    <description>The Baseline body weight value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the body weight value at Week 24 minus the value at Baseline. Participants who discontinued from the study treatment before Week 24 had their last non-missing weight carried forward for the summary, unless the value is past 14 days after the last dose of study drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Body Weight at Week 52</measure>
    <time_frame>Baseline and Week 52</time_frame>
    <description>The Baseline body weight value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the body weight value at Week 52 minus the value at Baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Study Withdrawal Due to Hyperglycemia</measure>
    <time_frame>Baseline through Week 52</time_frame>
    <description>Participants who experienced persistent hyperglycemia after uptitration were to be withdrawn from the study. Hyperglycemia is defined as a fasting plasma glucose (FPG) ≥280 mg/dL (≥15.5 mmol/L) from ≥Week 2 to &lt;Week 4, ≥250 mg/dL (≥13.9 mmol/L) from ≥Week 4 to &lt;Week 12, or ≥230 mg/dL (≥12.8 mmol/L) from ≥Week 12 to &lt;Week 52, confirmed a second evaluation within 7 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Study Withdrawal for Any Reason</measure>
    <time_frame>Baseline through Week 52</time_frame>
    <description>Time to withdrawal was calculated as the number of days between the date of first dose and the date of withdrawal plus 1. Time to withdrawal was summarized by visit.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">494</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Albiglutide 30 mg weekly</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be randomly assigned to double blind albiglutide 30 mg weekly treatment for 52 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Albiglutide 50 mg weekly</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be randomly assigned to double blind albiglutide 50 mg weekly until Week 52</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects will be randomly assigned to double blind matching albiglutide placebo administered weekly. Subjects will then cross-over to double-blind treatment with albiglutide 30 mg weekly at Week 24 until Week 52</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Liraglutide 0.9 mg daily</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will be randomly assigned to open-label liraglutide for 52 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Albiglutide 30 mg weekly</intervention_name>
    <description>Albiglutide will be available as a pen injector that delivers 30mg of albiglutide</description>
    <arm_group_label>Albiglutide 30 mg weekly</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Albiglutide 50 mg weekly</intervention_name>
    <description>Albiglutide will be available as a pen injector that delivers 50mg of albiglutide</description>
    <arm_group_label>Albiglutide 50 mg weekly</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Albiglutide matching placebo will be available as a pen injector</description>
    <arm_group_label>Albiglutide 30 mg weekly</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Liraglutide 0.9 mg daily</intervention_name>
    <description>Liraglutide will be available as prefilled multidose pens that can deliver 0.9 mg dose</description>
    <arm_group_label>Liraglutide 0.9 mg daily</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects with diagnosis of Type 2 Diabetes Mellitus, treated with diet and exercise or&#xD;
             a stable dose of 1 OAD at screening&#xD;
&#xD;
          -  Body mass index (BMI) 17 to 40 kg/ m^2 inclusive&#xD;
&#xD;
          -  Subjects who are OAD naïve, HbA1c between 7.0% and 10.0% at Screening and at Visit 2;&#xD;
             for subjects who enter the study with 1 OAD, HbA1c between 6.5% and 9.5% at Screening&#xD;
             and HbA1c between 7.0% and 10.0% at Visit 2&#xD;
&#xD;
          -  Creatinine clearance &gt;30 mL/min (calculated using the Cockcroft-Gault formula)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of type 1 diabetes mellitus •Female subject is pregnant, lactating, or &lt;6&#xD;
             weeks postpartum•&#xD;
&#xD;
          -  Clinically significant cardiovascular and/or cerebrovascular disease&#xD;
&#xD;
          -  Current ongoing symptomatic biliary disease, clinical signs or symptoms of&#xD;
             pancreatitis, or a history of chronic or acute pancreatitis, as determined by the&#xD;
             investigator&#xD;
&#xD;
          -  Serum amylase &gt;=3 ×ULN and/or serum lipase &gt;=2 × ULN and/or subject is experiencing&#xD;
             any symptoms possibly related to pancreatitis&#xD;
&#xD;
          -  Prior use of a TZD or GLP-1R agonist within 4 months before Screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Aichi</city>
        <zip>456-0058</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Chiba</city>
        <zip>263-0043</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ehime</city>
        <zip>790-0067</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ehime</city>
        <zip>792-0045</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ehime</city>
        <zip>792-8586</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Fukuoka</city>
        <zip>810-0014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Fukuoka</city>
        <zip>812-0053</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Fukuoka</city>
        <zip>815-8588</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Fukuoka</city>
        <zip>819-0168</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Fukushima</city>
        <zip>960-0418</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Fukushima</city>
        <zip>961-0416</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Fukushima</city>
        <zip>963-8851</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Fukushima</city>
        <zip>964-8501</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Gunma</city>
        <zip>370-3573</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Gunma</city>
        <zip>379-0116</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hiroshima</city>
        <zip>731-0103</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hokkaido</city>
        <zip>040-8585</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hokkaido</city>
        <zip>062-0007</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hokkaido</city>
        <zip>070-0002</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hokkaido</city>
        <zip>072-0012</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hokkaido</city>
        <zip>080-0010</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hokkaido</city>
        <zip>080-0016</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hyogo</city>
        <zip>670-0074</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ibaraki</city>
        <zip>300-0835</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ibaraki</city>
        <zip>300-1512</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ibaraki</city>
        <zip>311-0113</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kagawa</city>
        <zip>760-0017</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kagawa</city>
        <zip>760-0076</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kagoshima</city>
        <zip>890-0061</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kanagawa</city>
        <zip>212-0024</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kanagawa</city>
        <zip>232-0064</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kanagawa</city>
        <zip>235-0045</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kanagawa</city>
        <zip>238-0011</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kanagawa</city>
        <zip>242-0004</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kanagawa</city>
        <zip>253-0044</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kochi</city>
        <zip>780-0088</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kumamoto</city>
        <zip>862-0976</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kumamoto</city>
        <zip>866-8660</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kumamoto</city>
        <zip>867-0041</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kyoto</city>
        <zip>600-8558</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kyoto</city>
        <zip>601-1495</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Miyagi</city>
        <zip>980-0021</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Miyagi</city>
        <zip>985-0852</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Nagano</city>
        <zip>385-0022</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Nagano</city>
        <zip>399-0006</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Nagano</city>
        <zip>399-0036</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Nara</city>
        <zip>634-0007</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Oita</city>
        <zip>870-0039</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Oita</city>
        <zip>876-0851</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Okinawa</city>
        <zip>901-0243</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Osaka</city>
        <zip>530-0001</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Osaka</city>
        <zip>530-0004</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Osaka</city>
        <zip>530-0012</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Osaka</city>
        <zip>532-0026</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Osaka</city>
        <zip>536-0023</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Osaka</city>
        <zip>538-0044</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Osaka</city>
        <zip>577-0803</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Saitama</city>
        <zip>332-0012</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Saitama</city>
        <zip>350-0035</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Saitama</city>
        <zip>350-0851</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Saitama</city>
        <zip>354-0031</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Saitama</city>
        <zip>355-0321</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Saitama</city>
        <zip>358-0011</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Shizuoka</city>
        <zip>424-0855</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tochigi</city>
        <zip>329-0433</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>103-0002</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>103-0027</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>103-0028</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>104-0031</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>104-0061</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>125-0054</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>136-0073</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>143-0015</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Yamaguchi</city>
        <zip>755-0047</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <link>
    <url>https://www.clinicalstudydatarequest.com</url>
    <description>Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.</description>
  </link>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>November 21, 2012</study_first_submitted>
  <study_first_submitted_qc>November 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <results_first_submitted>April 2, 2015</results_first_submitted>
  <results_first_submitted_qc>April 30, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">May 18, 2015</results_first_posted>
  <last_update_submitted>August 12, 2016</last_update_submitted>
  <last_update_submitted_qc>August 12, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 22, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>albiglutide</keyword>
  <keyword>Japanese</keyword>
  <keyword>GSK716155</keyword>
  <keyword>Type 2 diabetes mellitus</keyword>
  <keyword>glucagon-like peptide 1</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liraglutide</mesh_term>
    <mesh_term>rGLP-1 protein</mesh_term>
    <mesh_term>Glucagon-Like Peptide 1</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.</ipd_description>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_id>113121</doc_id>
      <doc_type>Dataset Specification</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>113121</doc_id>
      <doc_type>Annotated Case Report Form</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>113121</doc_id>
      <doc_type>Individual Participant Data Set</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>113121</doc_id>
      <doc_type>Clinical Study Report</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>113121</doc_id>
      <doc_type>Study Protocol</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>113121</doc_id>
      <doc_type>Informed Consent Form</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>113121</doc_id>
      <doc_type>Statistical Analysis Plan</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
  </study_docs>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 494 participants (par.) were randomized to one of the four treatment groups - placebo (switched to albiglutide 30 mg at Week 24), albiglutide 30 mg, albiglutide 50 mg, liraglutide (open label), 490 par. took at least one dose of study drug (Safety Population). All 490 par. were included in Intent-to-Treat Population.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly to Week 52.</description>
        </group>
        <group group_id="P2">
          <title>Albiglutide 30 mg Weekly</title>
          <description>Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.</description>
        </group>
        <group group_id="P3">
          <title>Albiglutide 50 mg Weekly</title>
          <description>Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.</description>
        </group>
        <group group_id="P4">
          <title>Open Label Liraglutide 0.9 mg Daily</title>
          <description>Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="77"/>
                <participants group_id="P2" count="160"/>
                <participants group_id="P3" count="150"/>
                <participants group_id="P4" count="103"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="62"/>
                <participants group_id="P2" count="148"/>
                <participants group_id="P3" count="135"/>
                <participants group_id="P4" count="95"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="15"/>
                <participants group_id="P4" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Persistent Hyperglycemia</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-compliance</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Intro of New Anti-Diabetic Medication</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Inv Decision, HbA1c not controlled</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline characteristics are presented for the Safety Population.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Participants received double blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.</description>
        </group>
        <group group_id="B2">
          <title>Albiglutide 30 mg Weekly</title>
          <description>Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.</description>
        </group>
        <group group_id="B3">
          <title>Albiglutide 50 mg Weekly</title>
          <description>Participants received double blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.</description>
        </group>
        <group group_id="B4">
          <title>Open Label Liraglutide 0.9 mg Daily</title>
          <description>Participants received open label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="77"/>
            <count group_id="B2" value="160"/>
            <count group_id="B3" value="150"/>
            <count group_id="B4" value="103"/>
            <count group_id="B5" value="490"/>
          </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="57.3" spread="11.27"/>
                    <measurement group_id="B2" value="59.6" spread="9.00"/>
                    <measurement group_id="B3" value="57.7" spread="9.51"/>
                    <measurement group_id="B4" value="58.4" spread="9.72"/>
                    <measurement group_id="B5" value="58.4" spread="9.70"/>
                  </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="25"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="36"/>
                    <measurement group_id="B4" value="22"/>
                    <measurement group_id="B5" value="118"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                    <measurement group_id="B2" value="125"/>
                    <measurement group_id="B3" value="114"/>
                    <measurement group_id="B4" value="81"/>
                    <measurement group_id="B5" value="372"/>
                  </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>Asian - Japanese Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="77"/>
                    <measurement group_id="B2" value="160"/>
                    <measurement group_id="B3" value="150"/>
                    <measurement group_id="B4" value="103"/>
                    <measurement group_id="B5" value="490"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Model-adjusted Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24</title>
        <description>HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. The Baseline HbA1c value is defined as the last nonmissing value before the start of treatment. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. Based on analysis of covariance (ANCOVA): Change at Week 24 = treatment (placebo, albiglutide 30 mg, albiglutide 50 mg) + Baseline HbA1c + prior diabetes therapy + age category (&lt;65 years versus ≥65 years). Participants who discontinued from study treatment before Week 24 had their last post-Baseline HbA1c carried forward for the analysis unless the value is past 14 days after the last dose of study drug. The open-label liraglutide group was a reference group and not included in the primary endpoint analysis model. Descriptive summary statistics are provided as a separate outcome measure.</description>
        <time_frame>Baseline and Week 24</time_frame>
        <population>Intent-to-Treat Population (Last Observation Carried Forward): all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment of HbA1c.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.</description>
          </group>
          <group group_id="O2">
            <title>Albiglutide 30 mg Weekly</title>
            <description>Participants received double blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.</description>
          </group>
          <group group_id="O3">
            <title>Albiglutide 50 mg Weekly</title>
            <description>Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.</description>
          </group>
          <group group_id="O4">
            <title>Open-Label Liraglutide 0.9 mg Daily</title>
            <description>Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Model-adjusted Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24</title>
          <description>HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. The Baseline HbA1c value is defined as the last nonmissing value before the start of treatment. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. Based on analysis of covariance (ANCOVA): Change at Week 24 = treatment (placebo, albiglutide 30 mg, albiglutide 50 mg) + Baseline HbA1c + prior diabetes therapy + age category (&lt;65 years versus ≥65 years). Participants who discontinued from study treatment before Week 24 had their last post-Baseline HbA1c carried forward for the analysis unless the value is past 14 days after the last dose of study drug. The open-label liraglutide group was a reference group and not included in the primary endpoint analysis model. Descriptive summary statistics are provided as a separate outcome measure.</description>
          <population>Intent-to-Treat Population (Last Observation Carried Forward): all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment of HbA1c.</population>
          <units>Percentage of HbA1c in the blood</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="77"/>
                <count group_id="O2" value="159"/>
                <count group_id="O3" value="150"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.25" spread="0.068"/>
                    <measurement group_id="O2" value="-1.10" spread="0.047"/>
                    <measurement group_id="O3" value="-1.30" spread="0.049"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-1.55</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.72</ci_lower_limit>
            <ci_upper_limit>-1.39</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>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-1.35</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.51</ci_lower_limit>
            <ci_upper_limit>-1.18</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>The first test in a sequential testing procedure starting with albiglutide 50 mg versus placebo, and if significant at 0.05 level, followed by albiglutide 30 mg versus placebo.</p_value_desc>
            <method>t-test, 2 sided</method>
            <method_desc>The p-value is from a 2-sided t-test to test whether the difference of least squares (LS) means (albiglutide 50 mg - placebo) is equal to zero.</method_desc>
          </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;0.0001</p_value>
            <p_value_desc>The second test in a sequential testing procedure starting with albiglutide 50 mg versus placebo, and if significant at 0.05 level, followed by albiglutide 30 mg versus placebo.</p_value_desc>
            <method>t-test, 2 sided</method>
            <method_desc>The p-value is from a 2-sided t-test to test whether the difference of LS means (albiglutide 30 mg - placebo) is equal to zero.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean HbA1c at Baseline, Week 24, and Change From Baseline at Week 24</title>
        <description>HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. The Baseline HbA1c value is defined as the last nonmissing value before the start of treatment. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. Participants who discontinued from study treatment before Week 24 had their last post-Baseline HbA1c value carried forward for the summary, unless the value was past 14 days after the last dose of study drug. The open-label liraglutide group was a reference group; descriptive statistics comparing albiglutide and liraglutide were exploratory endpoints.</description>
        <time_frame>Baseline and Week 24</time_frame>
        <population>Intent-to-Treat Population (Last Observation Carried Forward): all randomized participants who received at least 1 dose of study treatment and had a Baseline assessment and at least 1 post-Baseline assessment of HbA1c on or before Week 24 provided it was not past more than 14 days after the last dose of study drug intake.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.</description>
          </group>
          <group group_id="O2">
            <title>Albiglutide 30 mg Weekly</title>
            <description>Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.</description>
          </group>
          <group group_id="O3">
            <title>Albiglutide 50 mg Weekly</title>
            <description>Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.</description>
          </group>
          <group group_id="O4">
            <title>Open-Label Liraglutide 0.9 mg Daily</title>
            <description>Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean HbA1c at Baseline, Week 24, and Change From Baseline at Week 24</title>
          <description>HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. The Baseline HbA1c value is defined as the last nonmissing value before the start of treatment. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. Participants who discontinued from study treatment before Week 24 had their last post-Baseline HbA1c value carried forward for the summary, unless the value was past 14 days after the last dose of study drug. The open-label liraglutide group was a reference group; descriptive statistics comparing albiglutide and liraglutide were exploratory endpoints.</description>
          <population>Intent-to-Treat Population (Last Observation Carried Forward): all randomized participants who received at least 1 dose of study treatment and had a Baseline assessment and at least 1 post-Baseline assessment of HbA1c on or before Week 24 provided it was not past more than 14 days after the last dose of study drug intake.</population>
          <units>Percentage of HbA1c in the blood</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="77"/>
                <count group_id="O2" value="159"/>
                <count group_id="O3" value="150"/>
                <count group_id="O4" value="103"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.16" spread="0.877"/>
                    <measurement group_id="O2" value="8.06" spread="0.783"/>
                    <measurement group_id="O3" value="8.15" spread="0.825"/>
                    <measurement group_id="O4" value="8.07" spread="0.787"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.39" spread="1.066"/>
                    <measurement group_id="O2" value="6.98" spread="0.735"/>
                    <measurement group_id="O3" value="6.83" spread="0.659"/>
                    <measurement group_id="O4" value="6.87" spread="0.642"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.24" spread="0.715"/>
                    <measurement group_id="O2" value="-1.08" spread="0.619"/>
                    <measurement group_id="O3" value="-1.32" spread="0.702"/>
                    <measurement group_id="O4" value="-1.19" spread="0.636"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in HbA1c at Week 52</title>
        <description>HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3- month period. The Baseline HbA1c value is defined as the last non-missing value on or before the start of treatment. Change from Baseline was calculated as the value at Week 52 minus the value at Baseline.</description>
        <time_frame>Baseline and Week 52</time_frame>
        <population>Intent-to-Treat (Observed Case) Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment. Participants who discontinued from study treatment before Week 52 were not included in the analysis. No missing data were imputed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.</description>
          </group>
          <group group_id="O2">
            <title>Albiglutide 30 mg Weekly</title>
            <description>Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.</description>
          </group>
          <group group_id="O3">
            <title>Albiglutide 50 mg Weekly</title>
            <description>Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.</description>
          </group>
          <group group_id="O4">
            <title>Open-Label Liraglutide 0.9 mg Daily</title>
            <description>Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in HbA1c at Week 52</title>
          <description>HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3- month period. The Baseline HbA1c value is defined as the last non-missing value on or before the start of treatment. Change from Baseline was calculated as the value at Week 52 minus the value at Baseline.</description>
          <population>Intent-to-Treat (Observed Case) Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment. Participants who discontinued from study treatment before Week 52 were not included in the analysis. No missing data were imputed.</population>
          <units>Percentage of HbA1c in the blood</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="148"/>
                <count group_id="O3" value="135"/>
                <count group_id="O4" value="95"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.07" spread="0.695"/>
                    <measurement group_id="O2" value="-1.07" spread="0.790"/>
                    <measurement group_id="O3" value="-1.34" spread="0.753"/>
                    <measurement group_id="O4" value="-1.17" spread="0.776"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of &lt;6.5% and &lt;7.0%) at Week 24</title>
        <description>HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. Clinically meaningful levels of response in HbA1c are defined as &lt;6.5% and &lt;7.0%. Participants who discontinued the study before Week 24 had their last post-Baseline HbA1c value carried forwrad for the summary unless the value was past 14 days after the last dose of study drug.</description>
        <time_frame>Week 24</time_frame>
        <population>Intent-to-Treat (Last Observation Carried Forward) Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.</description>
          </group>
          <group group_id="O2">
            <title>Albiglutide 30 mg Weekly</title>
            <description>Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.</description>
          </group>
          <group group_id="O3">
            <title>Albiglutide 50 mg Weekly</title>
            <description>Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.</description>
          </group>
          <group group_id="O4">
            <title>Open-Label Liraglutide 0.9 mg Daily</title>
            <description>Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of &lt;6.5% and &lt;7.0%) at Week 24</title>
          <description>HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. Clinically meaningful levels of response in HbA1c are defined as &lt;6.5% and &lt;7.0%. Participants who discontinued the study before Week 24 had their last post-Baseline HbA1c value carried forwrad for the summary unless the value was past 14 days after the last dose of study drug.</description>
          <population>Intent-to-Treat (Last Observation Carried Forward) Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="77"/>
                <count group_id="O2" value="159"/>
                <count group_id="O3" value="150"/>
                <count group_id="O4" value="103"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>HbA1c &lt;6.5% at Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="31"/>
                    <measurement group_id="O3" value="47"/>
                    <measurement group_id="O4" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HbA1c &lt;7.0% at Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="92"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of &lt;6.5% and &lt;7.0%) at Week 52</title>
        <description>HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. Clinically meaningful levels of response in HbA1c are defined as &lt;6.5% and &lt;7.0%.</description>
        <time_frame>Week 52</time_frame>
        <population>Intent-to-Treat (Observed Case) Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment. Participants who discontinued from study treatment before Week 52 were not included in the analysis. No missing data were imputed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.</description>
          </group>
          <group group_id="O2">
            <title>Albiglutide 30 mg Weekly</title>
            <description>Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.</description>
          </group>
          <group group_id="O3">
            <title>Albiglutide 50 mg Weekly</title>
            <description>Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.</description>
          </group>
          <group group_id="O4">
            <title>Open-Label Liraglutide 0.9 mg Daily</title>
            <description>Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of &lt;6.5% and &lt;7.0%) at Week 52</title>
          <description>HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. Clinically meaningful levels of response in HbA1c are defined as &lt;6.5% and &lt;7.0%.</description>
          <population>Intent-to-Treat (Observed Case) Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment. Participants who discontinued from study treatment before Week 52 were not included in the analysis. No missing data were imputed.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="148"/>
                <count group_id="O3" value="135"/>
                <count group_id="O4" value="95"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>HbA1c &lt;6.5% at Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="44"/>
                    <measurement group_id="O3" value="53"/>
                    <measurement group_id="O4" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HbA1c &lt;7.0% at Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                    <measurement group_id="O2" value="82"/>
                    <measurement group_id="O3" value="85"/>
                    <measurement group_id="O4" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24</title>
        <description>FPG is an indicator of efficacy. The Baseline FPG value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the FPG value at Week 24 minus the FPG value at Baseline. Participants who discontinued from study treatment before Week 24 had their last post-Baseline FPG observation carried forward for the summary unless the value was 14 days past the last dose of study drug.</description>
        <time_frame>Baseline and Week 24</time_frame>
        <population>Intent-to-Treat (Last Observation Carried Forward) Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.</description>
          </group>
          <group group_id="O2">
            <title>Albiglutide 30 mg Weekly</title>
            <description>Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.</description>
          </group>
          <group group_id="O3">
            <title>Albiglutide 50 mg Weekly</title>
            <description>Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.</description>
          </group>
          <group group_id="O4">
            <title>Open-Label Liraglutide 0.9 mg Daily</title>
            <description>Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24</title>
          <description>FPG is an indicator of efficacy. The Baseline FPG value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the FPG value at Week 24 minus the FPG value at Baseline. Participants who discontinued from study treatment before Week 24 had their last post-Baseline FPG observation carried forward for the summary unless the value was 14 days past the last dose of study drug.</description>
          <population>Intent-to-Treat (Last Observation Carried Forward) Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment.</population>
          <units>Milligrams per deciliter (mg/dL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="77"/>
                <count group_id="O2" value="159"/>
                <count group_id="O3" value="150"/>
                <count group_id="O4" value="103"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="159.3" spread="37.07"/>
                    <measurement group_id="O2" value="157.1" spread="33.81"/>
                    <measurement group_id="O3" value="158.7" spread="32.82"/>
                    <measurement group_id="O4" value="157.2" spread="31.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="167.0" spread="37.51"/>
                    <measurement group_id="O2" value="132.2" spread="26.09"/>
                    <measurement group_id="O3" value="128.8" spread="24.03"/>
                    <measurement group_id="O4" value="128.1" spread="23.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.7" spread="31.77"/>
                    <measurement group_id="O2" value="-24.9" spread="27.58"/>
                    <measurement group_id="O3" value="-30.0" spread="27.83"/>
                    <measurement group_id="O4" value="-29.1" spread="29.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52</title>
        <description>FPG is an indicator of efficacy. The Baseline FPG value is defined as the last non-missing value on or before the start of treatment. Change from Baseline was calculated as the FPG value at Week 52 minus the FPG value at Baseline.</description>
        <time_frame>Baseline and Week 52</time_frame>
        <population>Intent-to-Treat (Observed Case) Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment. Participants who discontinued from study treatment before Week 52 were not included in this analysis. No missing data were imputed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.</description>
          </group>
          <group group_id="O2">
            <title>Albiglutide 30 mg Weekly</title>
            <description>Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.</description>
          </group>
          <group group_id="O3">
            <title>Albiglutide 50 mg Weekly</title>
            <description>Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.</description>
          </group>
          <group group_id="O4">
            <title>Open-Label Liraglutide 0.9 mg Daily</title>
            <description>Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52</title>
          <description>FPG is an indicator of efficacy. The Baseline FPG value is defined as the last non-missing value on or before the start of treatment. Change from Baseline was calculated as the FPG value at Week 52 minus the FPG value at Baseline.</description>
          <population>Intent-to-Treat (Observed Case) Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment. Participants who discontinued from study treatment before Week 52 were not included in this analysis. No missing data were imputed.</population>
          <units>Milligrams per deciliter (mg/dL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="147"/>
                <count group_id="O3" value="135"/>
                <count group_id="O4" value="95"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="154.5" spread="35.65"/>
                    <measurement group_id="O2" value="154.7" spread="29.36"/>
                    <measurement group_id="O3" value="159.8" spread="33.52"/>
                    <measurement group_id="O4" value="157.4" spread="30.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="131.7" spread="23.13"/>
                    <measurement group_id="O2" value="131.9" spread="24.14"/>
                    <measurement group_id="O3" value="126.3" spread="24.47"/>
                    <measurement group_id="O4" value="127.0" spread="20.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-22.7" spread="27.38"/>
                    <measurement group_id="O2" value="-22.8" spread="26.03"/>
                    <measurement group_id="O3" value="-33.5" spread="31.10"/>
                    <measurement group_id="O4" value="-30.4" spread="28.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Body Weight at Week 24</title>
        <description>The Baseline body weight value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the body weight value at Week 24 minus the value at Baseline. Participants who discontinued from the study treatment before Week 24 had their last non-missing weight carried forward for the summary, unless the value is past 14 days after the last dose of study drug.</description>
        <time_frame>Baseline and Week 24</time_frame>
        <population>Intent-to-Treat (Last Observation Carried Forward) Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.</description>
          </group>
          <group group_id="O2">
            <title>Albiglutide 30 mg Weekly</title>
            <description>Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.</description>
          </group>
          <group group_id="O3">
            <title>Albiglutide 50 mg Weekly</title>
            <description>Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.</description>
          </group>
          <group group_id="O4">
            <title>Open-Label Liraglutide 0.9 mg Daily</title>
            <description>Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Body Weight at Week 24</title>
          <description>The Baseline body weight value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the body weight value at Week 24 minus the value at Baseline. Participants who discontinued from the study treatment before Week 24 had their last non-missing weight carried forward for the summary, unless the value is past 14 days after the last dose of study drug.</description>
          <population>Intent-to-Treat (Last Observation Carried Forward) Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment.</population>
          <units>Kilograms (kg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="77"/>
                <count group_id="O2" value="159"/>
                <count group_id="O3" value="150"/>
                <count group_id="O4" value="103"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.65" spread="12.088"/>
                    <measurement group_id="O2" value="69.46" spread="13.453"/>
                    <measurement group_id="O3" value="71.54" spread="12.907"/>
                    <measurement group_id="O4" value="72.65" spread="13.758"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.15" spread="12.139"/>
                    <measurement group_id="O2" value="69.78" spread="13.793"/>
                    <measurement group_id="O3" value="71.50" spread="13.023"/>
                    <measurement group_id="O4" value="72.30" spread="13.459"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.50" spread="1.700"/>
                    <measurement group_id="O2" value="0.32" spread="1.795"/>
                    <measurement group_id="O3" value="-0.04" spread="1.976"/>
                    <measurement group_id="O4" value="-0.34" spread="2.587"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Body Weight at Week 52</title>
        <description>The Baseline body weight value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the body weight value at Week 52 minus the value at Baseline.</description>
        <time_frame>Baseline and Week 52</time_frame>
        <population>Intent-to-Treat (Observed Case) Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment. Participants who discontinued before Week 52 from study treatment were not included in the analysis. No missing data were imputed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.</description>
          </group>
          <group group_id="O2">
            <title>Albiglutide 30 mg Weekly</title>
            <description>Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.</description>
          </group>
          <group group_id="O3">
            <title>Albiglutide 50 mg Weekly</title>
            <description>Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.</description>
          </group>
          <group group_id="O4">
            <title>Open-Label Liraglutide 0.9 mg Daily</title>
            <description>Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Body Weight at Week 52</title>
          <description>The Baseline body weight value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the body weight value at Week 52 minus the value at Baseline.</description>
          <population>Intent-to-Treat (Observed Case) Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment. Participants who discontinued before Week 52 from study treatment were not included in the analysis. No missing data were imputed.</population>
          <units>Kilograms (kg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="148"/>
                <count group_id="O3" value="135"/>
                <count group_id="O4" value="95"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.07" spread="11.978"/>
                    <measurement group_id="O2" value="70.07" spread="13.242"/>
                    <measurement group_id="O3" value="71.27" spread="12.801"/>
                    <measurement group_id="O4" value="72.43" spread="12.895"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.00" spread="12.150"/>
                    <measurement group_id="O2" value="70.15" spread="13.536"/>
                    <measurement group_id="O3" value="70.96" spread="12.431"/>
                    <measurement group_id="O4" value="71.93" spread="12.564"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.07" spread="2.179"/>
                    <measurement group_id="O2" value="0.08" spread="2.078"/>
                    <measurement group_id="O3" value="-0.31" spread="2.382"/>
                    <measurement group_id="O4" value="-0.50" spread="2.690"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Study Withdrawal Due to Hyperglycemia</title>
        <description>Participants who experienced persistent hyperglycemia after uptitration were to be withdrawn from the study. Hyperglycemia is defined as a fasting plasma glucose (FPG) ≥280 mg/dL (≥15.5 mmol/L) from ≥Week 2 to &lt;Week 4, ≥250 mg/dL (≥13.9 mmol/L) from ≥Week 4 to &lt;Week 12, or ≥230 mg/dL (≥12.8 mmol/L) from ≥Week 12 to &lt;Week 52, confirmed a second evaluation within 7 days.</description>
        <time_frame>Baseline through Week 52</time_frame>
        <population>Intent-to-Treat Population: all randomized par. who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment. Par. who did not conform to the protocol-defined criteria of persistent hyperglycemia with respect to FPG values defined above were not included in this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.</description>
          </group>
          <group group_id="O2">
            <title>Albiglutide 30 mg Weekly</title>
            <description>Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.</description>
          </group>
          <group group_id="O3">
            <title>Albiglutide 50 mg Weekly</title>
            <description>Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.</description>
          </group>
          <group group_id="O4">
            <title>Open-Label Liraglutide 0.9 mg Daily</title>
            <description>Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Study Withdrawal Due to Hyperglycemia</title>
          <description>Participants who experienced persistent hyperglycemia after uptitration were to be withdrawn from the study. Hyperglycemia is defined as a fasting plasma glucose (FPG) ≥280 mg/dL (≥15.5 mmol/L) from ≥Week 2 to &lt;Week 4, ≥250 mg/dL (≥13.9 mmol/L) from ≥Week 4 to &lt;Week 12, or ≥230 mg/dL (≥12.8 mmol/L) from ≥Week 12 to &lt;Week 52, confirmed a second evaluation within 7 days.</description>
          <population>Intent-to-Treat Population: all randomized par. who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment. Par. who did not conform to the protocol-defined criteria of persistent hyperglycemia with respect to FPG values defined above were not included in this analysis.</population>
          <units>Weeks</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="77"/>
                <count group_id="O2" value="160"/>
                <count group_id="O3" value="150"/>
                <count group_id="O4" value="103"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">There were too few events of withdrawals due to hyperglycemia to calculate the median and confidence interval.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">There were too few events of withdrawals due to hyperglycemia to calculate the median and confidence interval.</measurement>
                    <measurement group_id="O3" value="NA" lower_limit="NA" upper_limit="NA">There were too few events of withdrawals due to hyperglycemia to calculate the median and confidence interval.</measurement>
                    <measurement group_id="O4" value="NA" lower_limit="NA" upper_limit="NA">There were too few events of withdrawals due to hyperglycemia to calculate the median and confidence interval.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Study Withdrawal for Any Reason</title>
        <description>Time to withdrawal was calculated as the number of days between the date of first dose and the date of withdrawal plus 1. Time to withdrawal was summarized by visit.</description>
        <time_frame>Baseline through Week 52</time_frame>
        <population>Intent-to-Treat Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline assessment and at least one post-Baseline assessment (scheduled or unscheduled) of the primary endpoint, HbA1c.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.</description>
          </group>
          <group group_id="O2">
            <title>Albiglutide 30 mg Weekly</title>
            <description>Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.</description>
          </group>
          <group group_id="O3">
            <title>Albiglutide 50 mg Weekly</title>
            <description>Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.</description>
          </group>
          <group group_id="O4">
            <title>Open-Label Liraglutide 0.9 mg Daily</title>
            <description>Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Study Withdrawal for Any Reason</title>
          <description>Time to withdrawal was calculated as the number of days between the date of first dose and the date of withdrawal plus 1. Time to withdrawal was summarized by visit.</description>
          <population>Intent-to-Treat Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline assessment and at least one post-Baseline assessment (scheduled or unscheduled) of the primary endpoint, HbA1c.</population>
          <units>Weeks</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="77"/>
                <count group_id="O2" value="160"/>
                <count group_id="O3" value="150"/>
                <count group_id="O4" value="103"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">There were too few events of withdrawals for any reason to calculate the median and confidence interval.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">There were too few events of withdrawals for any reason to calculate the median and confidence interval.</measurement>
                    <measurement group_id="O3" value="NA" lower_limit="NA" upper_limit="NA">There were too few events of withdrawals for any reason to calculate the median and confidence interval.</measurement>
                    <measurement group_id="O4" value="NA" lower_limit="NA" upper_limit="NA">There were too few events of withdrawals for any reason to calculate the median and confidence interval.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>On-therapy non-serious AEs and serious AEs (SAEs), events with an onset on or after the start date of study treatment and within 56 days after the date of the last dose of study treatment, are summarized through Week 52.</time_frame>
      <desc>The nonserious AEs and SAEs are reported for the Safety Population, comprised of all participants who received &gt;= 1 dose of study treatment. Randomized treatment allocation was by design imbalanced in a ratio of 3:6:6:4 for placebo, albiglutide 30 mg, albiglutide 50 mg, and liraglutide. Non-serious AEs excludes hypoglycemia events.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo - Before Switch</title>
          <description>(Before Switch to 30 mg albiglutide) Participants received double blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24.</description>
        </group>
        <group group_id="E2">
          <title>Placebo - After Switch</title>
          <description>(After Switch to 30 mg algiblutide) After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.</description>
        </group>
        <group group_id="E3">
          <title>Albiglutide 30 mg Weekly</title>
          <description>Participants received double blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.</description>
        </group>
        <group group_id="E4">
          <title>Albiglutide 50 mg Weekly</title>
          <description>Participants received double blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.</description>
        </group>
        <group group_id="E5">
          <title>Open Label Liraglutide 0.9 mg Daily</title>
          <description>Participants received open label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA</default_vocab>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="160"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="150"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Rathke's cleft cyst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="160"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="150"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Macular oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="160"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="150"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="160"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="150"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pulmonary tuberculosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="160"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="150"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Spinal compression fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="160"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="150"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Breast cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="160"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="150"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Gastric cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="160"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="150"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Lymphoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="160"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="150"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Pancreatic carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="160"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="150"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Plasma cell myeloma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="160"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="150"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Rectal Cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="160"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="150"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebellar haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="160"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="150"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal failure acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="160"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="150"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA</default_vocab>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="33" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="24" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="85" subjects_at_risk="160"/>
                <counts group_id="E4" subjects_affected="76" subjects_at_risk="150"/>
                <counts group_id="E5" subjects_affected="46" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="160"/>
                <counts group_id="E4" subjects_affected="17" subjects_at_risk="150"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="160"/>
                <counts group_id="E4" subjects_affected="10" subjects_at_risk="150"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="160"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="150"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection site erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="160"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="150"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="45" subjects_at_risk="160"/>
                <counts group_id="E4" subjects_affected="34" subjects_at_risk="150"/>
                <counts group_id="E5" subjects_affected="25" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="160"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="150"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="160"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="150"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="160"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="150"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="160"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="150"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract inflammation</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="160"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="150"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="65"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="160"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="150"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="103"/>
              </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>GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>GSK Response Center</name_or_title>
      <organization>GlaxoSmithKline</organization>
      <phone>866-435-7343</phone>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01733758
org study id: 113121
nct id: NCT01733758
lead sponsor: 
has dmc: Yes
This study is designed to examine the efficacy and safety of 2 dose levels of weekly
      subcutaneously injected albiglutide compared with placebo and an open label reference arm of
      daily subcutaneous injections of liraglutide, in Japanese subjects with Type 2 diabetes
      mellitus.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Model-adjusted Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
time frame: Baseline and Week 24
description: HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. The Baseline HbA1c value is defined as the last nonmissing value before the start of treatment. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. Based on analysis of covariance (ANCOVA): Change at Week 24 = treatment (placebo, albiglutide 30 mg, albiglutide 50 mg) + Baseline HbA1c + prior diabetes therapy + age category (<65 years versus ≥65 years). Participants who discontinued from study treatment before Week 24 had their last post-Baseline HbA1c carried forward for the analysis unless the value is past 14 days after the last dose of study drug. The open-label liraglutide group was a reference group and not included in the primary endpoint analysis model. Descriptive summary statistics are provided as a separate outcome measure.
measure: Mean HbA1c at Baseline, Week 24, and Change From Baseline at Week 24
time frame: Baseline and Week 24
description: HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. The Baseline HbA1c value is defined as the last nonmissing value before the start of treatment. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. Participants who discontinued from study treatment before Week 24 had their last post-Baseline HbA1c value carried forward for the summary, unless the value was past 14 days after the last dose of study drug. The open-label liraglutide group was a reference group; descriptive statistics comparing albiglutide and liraglutide were exploratory endpoints.
measure: Change From Baseline in HbA1c at Week 52
time frame: Baseline and Week 52
description: HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3- month period. The Baseline HbA1c value is defined as the last non-missing value on or before the start of treatment. Change from Baseline was calculated as the value at Week 52 minus the value at Baseline.
measure: Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of <6.5% and <7.0%) at Week 24
time frame: Week 24
description: HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. Clinically meaningful levels of response in HbA1c are defined as <6.5% and <7.0%. Participants who discontinued the study before Week 24 had their last post-Baseline HbA1c value carried forwrad for the summary unless the value was past 14 days after the last dose of study drug.
measure: Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of <6.5% and <7.0%) at Week 52
time frame: Week 52
description: HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. Clinically meaningful levels of response in HbA1c are defined as <6.5% and <7.0%.
measure: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
time frame: Baseline and Week 24
description: FPG is an indicator of efficacy. The Baseline FPG value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the FPG value at Week 24 minus the FPG value at Baseline. Participants who discontinued from study treatment before Week 24 had their last post-Baseline FPG observation carried forward for the summary unless the value was 14 days past the last dose of study drug.
measure: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52
time frame: Baseline and Week 52
description: FPG is an indicator of efficacy. The Baseline FPG value is defined as the last non-missing value on or before the start of treatment. Change from Baseline was calculated as the FPG value at Week 52 minus the FPG value at Baseline.
measure: Change From Baseline in Body Weight at Week 24
time frame: Baseline and Week 24
description: The Baseline body weight value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the body weight value at Week 24 minus the value at Baseline. Participants who discontinued from the study treatment before Week 24 had their last non-missing weight carried forward for the summary, unless the value is past 14 days after the last dose of study drug.
measure: Change From Baseline in Body Weight at Week 52
time frame: Baseline and Week 52
description: The Baseline body weight value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the body weight value at Week 52 minus the value at Baseline.
measure: Time to Study Withdrawal Due to Hyperglycemia
time frame: Baseline through Week 52
description: Participants who experienced persistent hyperglycemia after uptitration were to be withdrawn from the study. Hyperglycemia is defined as a fasting plasma glucose (FPG) ≥280 mg/dL (≥15.5 mmol/L) from ≥Week 2 to <Week 4, ≥250 mg/dL (≥13.9 mmol/L) from ≥Week 4 to <Week 12, or ≥230 mg/dL (≥12.8 mmol/L) from ≥Week 12 to <Week 52, confirmed a second evaluation within 7 days.
measure: Time to Study Withdrawal for Any Reason
time frame: Baseline through Week 52
description: Time to withdrawal was calculated as the number of days between the date of first dose and the date of withdrawal plus 1. Time to withdrawal was summarized by visit.
arm group label: Albiglutide 30 mg weekly
arm group type: Experimental
description: Subjects will be randomly assigned to double blind albiglutide 30 mg weekly treatment for 52 weeks
arm group label: Albiglutide 50 mg weekly
arm group type: Experimental
description: Subjects will be randomly assigned to double blind albiglutide 50 mg weekly until Week 52
arm group label: Placebo
arm group type: Placebo Comparator
description: Subjects will be randomly assigned to double blind matching albiglutide placebo administered weekly. Subjects will then cross-over to double-blind treatment with albiglutide 30 mg weekly at Week 24 until Week 52
arm group label: Liraglutide 0.9 mg daily
arm group type: Active Comparator
description: Subjects will be randomly assigned to open-label liraglutide for 52 weeks
intervention type: Drug
intervention name: Albiglutide 30 mg weekly
description: Albiglutide will be available as a pen injector that delivers 30mg of albiglutide
arm group label: Albiglutide 30 mg weekly
intervention type: Drug
intervention name: Albiglutide 50 mg weekly
description: Albiglutide will be available as a pen injector that delivers 50mg of albiglutide
arm group label: Albiglutide 50 mg weekly
intervention type: Drug
intervention name: Placebo
description: Albiglutide matching placebo will be available as a pen injector
arm group label: Albiglutide 30 mg weekly
arm group label: Placebo
intervention type: Drug
intervention name: Liraglutide 0.9 mg daily
description: Liraglutide will be available as prefilled multidose pens that can deliver 0.9 mg dose
arm group label: Liraglutide 0.9 mg daily
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
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country: Japan
url: https://www.clinicalstudydatarequest.com
description: Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Liraglutide
mesh term: rGLP-1 protein
mesh term: Glucagon-Like Peptide 1
sharing ipd: Yes
ipd description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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