<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/NCT02243176</url>
  </required_header>
  <id_info>
    <org_study_id>D1680L00018</org_study_id>
    <nct_id>NCT02243176</nct_id>
  </id_info>
  <brief_title>24-Week, Multicenter, Randomized, Parallel-group, Open-label, Active Controlled Phase IV Study to Assess the Efficacy, Safety and Tolerability of Saxagliptin Compared With Acarbose When in Combination With Metformin in Patients With T2D Inadequately Controlled With Metformin Monotherapy</brief_title>
  <acronym>SMART</acronym>
  <official_title>SMART Study - A 24-Week, Multicenter, Randomized, Parallel-group, Open-label, Active Controlled Phase IV Study to Assess the Efficacy, Safety and Tolerability of Saxagliptin Compared With Acarbose When in Combination With Metformin in Patients With Type 2 Diabetes Mellitus (T2D) Inadequately Controlled With Metformin Monotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AstraZeneca</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      SMART Study - A 24-Week, Multicenter, Randomized, Parallel-group, Open-label, Active&#xD;
      Controlled Phase IV Study to Assess the Efficacy, Safety and Tolerability of Saxagliptin&#xD;
      Compared with Acarbose when in Combination with Metformin in Patients with Type 2 Diabetes&#xD;
      Mellitus (T2D) Inadequately Controlled with Metformin Monotherapy&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</primary_completion_date>
  <phase>Phase 4</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Absolute Change From Baseline in HbA1c at Week 24 (DAO)</measure>
    <time_frame>From baseline to 24 week</time_frame>
    <description>Primary Objective: Efficacy of saxagliptin plus metformin on glycemic control compared with acarbose plus metformin in patients with T2D inadequately controlled with metformin. By Measure absolute change from baseline in HbA1c at Week 24</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Absolute Change From Baseline in HbA1c at Week 24 (DAO)</measure>
    <time_frame>From baseline to 24 week</time_frame>
    <description>The primary endpoint was analyzed based on Per protocol analysis set as the supportive analysis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion (%) of Patients With Any GI Adverse Events</measure>
    <time_frame>24 weeks</time_frame>
    <description>Secondary Objective: Assessment of any gastrointestinal adverse events of saxagliptin versus acarbose. by measure proportion (%) of patients with any gastrointestinal adverse events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion (%) of Patients Achieving a Therapeutic Glycemic Response Defined as HbA1c&lt;7.0%</measure>
    <time_frame>24 weeks</time_frame>
    <description>Secondary Objective: Effects of saxagliptin versus acarbose on the additional parameters, by measure proportion (%) of patients achieving a therapeutic glycemic response defined as HbA1c&lt;7.0%</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion (%) of Patients Achieving HbA1c&lt;7.0% Without GI Adverse Events</measure>
    <time_frame>Whole study duration</time_frame>
    <description>Secondary Objective: Assessment of any gastrointestinal adverse events of saxagliptin versus acarbose. by measure proportion (%) of patients achieving HbA1c&lt;7.0% without GI adverse events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Fasting Plasma Glucose (FPG)</measure>
    <time_frame>From baseline to 24 week</time_frame>
    <description>Secondary objective: Effects of saxagliptin versus acarbose on the additional parameters, by measure change from baseline in fasting plasma glucose, 2h postprandial glucose, β-cell function, body weight at week 24</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in 2H Postprandial Glucose (2HPPG)</measure>
    <time_frame>From baseline to 24 week</time_frame>
    <description>Secondary objective: Effects of saxagliptin versus acarbose on the additional parameters, by measure change from baseline in fasting plasma glucose, 2h postprandial glucose, β-cell function, body weight at week 24</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in HOMA-β</measure>
    <time_frame>From baseline to 24 week</time_frame>
    <description>Secondary objective: Effects of saxagliptin versus acarbose on the additional parameters, by measure change from baseline in fasting plasma glucose, 2h postprandial glucose, β-cell function was estimated by the Homeostasis model assessment-β (HOMA-β), which was defined as fasting insulin (mU/mL) x 20 / (fasting glucose (mmol/mL) - 3.5, body weight at week 24</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Body Weight</measure>
    <time_frame>From baseline to 24 week</time_frame>
    <description>Secondary objective: Effects of saxagliptin versus acarbose on the additional parameters, by measure change from baseline in fasting plasma glucose, 2h postprandial glucose, β-cell function, body weight at week 24</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">689</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Saxagliptin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Acarbose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saxagliptin</intervention_name>
    <description>The dose of saxaglitpin will be 5mg oral qd.</description>
    <arm_group_label>Saxagliptin</arm_group_label>
    <other_name>Onglyza</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acarbose</intervention_name>
    <description>Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose.</description>
    <arm_group_label>Acarbose</arm_group_label>
    <other_name>Glucobay</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosed with type 2 diabetes mellitus&#xD;
&#xD;
          2. Men and women (non-pregnant and using a medically approved birth-control method) aged&#xD;
             at least 18 years at screening.&#xD;
&#xD;
          3. T2D patients treated with stable metformin monotherapy for at least 8 weeks prior to&#xD;
             screening. Metformin dose should be ≥ 1500 mg/day (or individual maximally tolerated&#xD;
             dose), but not more than the maximum dose specified in the label&#xD;
&#xD;
          4. HbA1c ≥ 7.5% and ≤ 11.0% at screening or within 4 weeks prior to screening (by local&#xD;
             laboratory) and HbA1c ≥ 7.0% and ≤ 11.0% at pre-randomization visit (by central&#xD;
             laboratory)&#xD;
&#xD;
          5. FPG ≤ 13.3 mmol/L (≤ 240 mg/dL) at pre-randomization visit (by central laboratory)&#xD;
&#xD;
          6. Able and willing to provide written informed consent and to comply with the study&#xD;
             protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Women who are pregnant, intending to become pregnant during the study period,&#xD;
             lactating females, or women of child-bearing potential not using highly effective,&#xD;
             medically approved birth control methods.&#xD;
&#xD;
          2. Diagnosis or history of:&#xD;
&#xD;
               1. Type 1 diabetes mellitus, diabetes resulting from pancreatic injury or secondary&#xD;
                  forms of diabetes, eg, acromegaly or Cushing's syndrome.&#xD;
&#xD;
               2. Acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma&#xD;
                  within the past 6 months.&#xD;
&#xD;
          3. Previous treatment with any dipeptidyl peptidase-4 (DPP4) inhibitor or GLP-1 receptor&#xD;
             agonists within the past one year.&#xD;
&#xD;
          4. History of hypersensitivity reaction (e.g., anaphylaxis, angioedema, exfoliative skin&#xD;
             conditions) to dipeptidyl peptidase-4 inhibitor (DPP4) or Acarbose.&#xD;
&#xD;
          5. Treatment with any anti-diabetic medication for more than 7 consecutive days other&#xD;
             than metformin in the last 8 weeks prior to screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>150 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2014</study_first_posted>
  <results_first_submitted>September 27, 2016</results_first_submitted>
  <results_first_submitted_qc>March 3, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">April 14, 2017</results_first_posted>
  <last_update_submitted>March 3, 2017</last_update_submitted>
  <last_update_submitted_qc>March 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Saxagliptin</keyword>
  <keyword>Acarbose</keyword>
  <keyword>Type 2 Diabetes</keyword>
  <keyword>Metformin</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>Saxagliptin</mesh_term>
    <mesh_term>Acarbose</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 689 patients were enrolled into this study from 35 sites in China. The enrolled patient number ranged from 10 to 58 among 24 centers, and 2 to 9 patients from eight centers, none was enrolled in 3 centers. The enrolment period was from 24 Sep 2014 to 29 Sep 2015.</recruitment_details>
      <pre_assignment_details>A total of 201 patients were enrolled but not randomized: 171 patients did not meet eligibility criteria, and 24 patients were voluntary discontinuations, two patients developed study-specific withdrawal criteria, one patient lost follow-up, and three patient failed due to other reasons</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Saxagliptin</title>
          <description>The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.</description>
        </group>
        <group group_id="P2">
          <title>Acarbose</title>
          <description>Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="244">3 of the randomized subjects withdrew before taking any medication</participants>
                <participants group_id="P2" count="244"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="230"/>
                <participants group_id="P2" count="229"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Other reason</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>protocol specified withdrawal critera</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The Full analysis set included all randomized subjects who took at least 1 randomized IP dose, and had at least 1 non-missing baseline and 1 post-baseline efficacy data assessments</population>
      <group_list>
        <group group_id="B1">
          <title>Saxagliptin</title>
          <description>The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.</description>
        </group>
        <group group_id="B2">
          <title>Acarbose</title>
          <description>Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.</description>
        </group>
        <group group_id="B3">
          <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="238"/>
            <count group_id="B2" value="243"/>
            <count group_id="B3" value="481"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54.7" spread="10.51"/>
                    <measurement group_id="B2" value="56.5" spread="10.81"/>
                    <measurement group_id="B3" value="55.6" spread="10.69"/>
                  </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="91"/>
                    <measurement group_id="B2" value="105"/>
                    <measurement group_id="B3" value="196"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="147"/>
                    <measurement group_id="B2" value="138"/>
                    <measurement group_id="B3" value="285"/>
                  </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 (China Mainland)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="238"/>
                    <measurement group_id="B2" value="243"/>
                    <measurement group_id="B3" value="481"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="166.3" spread="8"/>
                    <measurement group_id="B2" value="165.9" spread="7.75"/>
                    <measurement group_id="B3" value="166.1" spread="7.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="73.3" spread="12.61"/>
                    <measurement group_id="B2" value="72.6" spread="12.27"/>
                    <measurement group_id="B3" value="72.9" spread="12.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <description>Body Mass Index</description>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26.4" spread="3.47"/>
                    <measurement group_id="B2" value="26.3" spread="3.49"/>
                    <measurement group_id="B3" value="26.3" spread="3.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration of diabetes mellitus (years)</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.1" spread="4.4"/>
                    <measurement group_id="B2" value="5.3" spread="4.76"/>
                    <measurement group_id="B3" value="5.2" spread="4.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Type of diabetes mellitus</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Type 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="238"/>
                    <measurement group_id="B2" value="243"/>
                    <measurement group_id="B3" value="481"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Currently taking antidiabetic medication</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="238"/>
                    <measurement group_id="B2" value="243"/>
                    <measurement group_id="B3" value="481"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Any diabetes mellitus complications</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="214"/>
                    <measurement group_id="B2" value="221"/>
                    <measurement group_id="B3" value="435"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Any relevant medical conditions</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="119"/>
                    <measurement group_id="B2" value="125"/>
                    <measurement group_id="B3" value="244"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65"/>
                    <measurement group_id="B2" value="64"/>
                    <measurement group_id="B3" value="129"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="108"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Any current medication，excluding antidiabetic drugs</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="59"/>
                    <measurement group_id="B2" value="73"/>
                    <measurement group_id="B3" value="132"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="179"/>
                    <measurement group_id="B2" value="170"/>
                    <measurement group_id="B3" value="349"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HbA1c (%)</title>
          <description>Haemoglobin A1c</description>
          <units>%</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.23" spread="0.85"/>
                    <measurement group_id="B2" value="8.16" spread="0.81"/>
                    <measurement group_id="B3" value="8.20" spread="0.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>FPG</title>
          <description>Fasting Plasma Glucose</description>
          <units>mmol/l</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9.01" spread="2.14"/>
                    <measurement group_id="B2" value="8.81" spread="1.95"/>
                    <measurement group_id="B3" value="8.90" spread="2.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>2hPPG</title>
          <description>2h Postprandial Plasma Glucose</description>
          <units>mmol/l</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11.17" spread="2.82"/>
                    <measurement group_id="B2" value="10.25" spread="2.89"/>
                    <measurement group_id="B3" value="10.7" spread="2.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Triglycerides</title>
          <units>mmol/l</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.99" spread="1.12"/>
                    <measurement group_id="B2" value="1.96" spread="1.38"/>
                    <measurement group_id="B3" value="1.97" spread="1.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>TC</title>
          <description>Total Cholesterol</description>
          <units>mmol/l</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.78" spread="1.07"/>
                    <measurement group_id="B2" value="4.82" spread="0.94"/>
                    <measurement group_id="B3" value="4.80" spread="1.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>LDL</title>
          <description>Low Density Lipoprotein-Cholesterol</description>
          <units>mmol/l</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.73" spread="0.89"/>
                    <measurement group_id="B2" value="2.77" spread="0.79"/>
                    <measurement group_id="B3" value="2.75" spread="0.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HDL</title>
          <description>High Density Lipoprotein-Cholesterol</description>
          <units>mmol/l</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.16" spread="0.29"/>
                    <measurement group_id="B2" value="1.2" spread="0.3"/>
                    <measurement group_id="B3" value="1.18" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Absolute Change From Baseline in HbA1c at Week 24 (DAO)</title>
        <description>Primary Objective: Efficacy of saxagliptin plus metformin on glycemic control compared with acarbose plus metformin in patients with T2D inadequately controlled with metformin. By Measure absolute change from baseline in HbA1c at Week 24</description>
        <time_frame>From baseline to 24 week</time_frame>
        <population>The Full analysis set included all randomized subjects who took at least 1 randomized IP dose, and had at least 1 non-missing baseline and 1 post-baseline efficacy data assessments.</population>
        <group_list>
          <group group_id="O1">
            <title>Saxagliptin</title>
            <description>The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.</description>
          </group>
          <group group_id="O2">
            <title>Acarbose</title>
            <description>Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change From Baseline in HbA1c at Week 24 (DAO)</title>
          <description>Primary Objective: Efficacy of saxagliptin plus metformin on glycemic control compared with acarbose plus metformin in patients with T2D inadequately controlled with metformin. By Measure absolute change from baseline in HbA1c at Week 24</description>
          <population>The Full analysis set included all randomized subjects who took at least 1 randomized IP dose, and had at least 1 non-missing baseline and 1 post-baseline efficacy data assessments.</population>
          <units>% (HbA1c)</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="238"/>
                <count group_id="O2" value="243"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.82" spread="0.06"/>
                    <measurement group_id="O2" value="-0.78" spread="0.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>H01: μS-μA≥ 0.4% vs Ha1: μS-μA&lt; 0.4%. Null hypothesis will be rejected if the upper limit of 2-sided 95% CI is below 0.4%.If the null hypothesis above (H01) is rejected, the following hypothesis will be tested to further establish superiority:&#xD;
H02: μS-μA≥ 0 vs Ha2: μS-μA&lt; 0. This null hypothesis (H02) will be rejected if the upper limit of 2-sided 95% CI is below 0.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>With a total sample size of 480 patients randomized and an expected drop-out rate of 20%, the trial will be powered at 90% to establish non-inferiority for the primary endpoint, at a one-sided alpha level of 0.025, with the non-inferiority margin of 0.4%, assuming the true effects are the same between treatments. The calculation is also based on the assumption that the standard deviation for the change in HbA1c is 1.2%.</non_inferiority_desc>
            <p_value>0.6236</p_value>
            <p_value_desc>This p value is for the hypothesis of superiority</p_value_desc>
            <method>Mixed Model Repeated Measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.04</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.09</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.22</ci_lower_limit>
            <ci_upper_limit>0.13</ci_upper_limit>
            <estimate_desc>Mean difference=Saxagliptin - Acarbose</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Absolute Change From Baseline in HbA1c at Week 24 (DAO)</title>
        <description>The primary endpoint was analyzed based on Per protocol analysis set as the supportive analysis.</description>
        <time_frame>From baseline to 24 week</time_frame>
        <population>The Per Protocol analysis set was a subset of the Full analysis set that included subjects who did not have significant protocol deviations that affect the study outcome. The exclusions from the PP analysis set was determined prior to database lock.</population>
        <group_list>
          <group group_id="O1">
            <title>Saxagliptin</title>
            <description>The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.</description>
          </group>
          <group group_id="O2">
            <title>Acarbose</title>
            <description>Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change From Baseline in HbA1c at Week 24 (DAO)</title>
          <description>The primary endpoint was analyzed based on Per protocol analysis set as the supportive analysis.</description>
          <population>The Per Protocol analysis set was a subset of the Full analysis set that included subjects who did not have significant protocol deviations that affect the study outcome. The exclusions from the PP analysis set was determined prior to database lock.</population>
          <units>% (HbA1c)</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="219"/>
                <count group_id="O2" value="204"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.83" spread="0.06"/>
                    <measurement group_id="O2" value="-0.80" spread="0.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>H01: μS-μA≥ 0.4% vs Ha1: μS-μA&lt; 0.4%. Null hypothesis will be rejected if the upper limit of 2-sided 95% CI is below 0.4%.If the null hypothesis above (H01) is rejected, the following hypothesis will be tested to further establish superiority:&#xD;
H02: μS-μA≥ 0 vs Ha2: μS-μA&lt; 0. This null hypothesis (H02) will be rejected if the upper limit of 2-sided 95% CI is below 0.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>With a total sample size of 480 patients randomized and an expected drop-out rate of 20%, the trial will be powered at 90% to establish non-inferiority for the primary endpoint, at a one-sided alpha level of 0.025, with the non-inferiority margin of 0.4%, assuming the true effects are the same between treatments. The calculation is also based on the assumption that the standard deviation for the change in HbA1c is 1.2%.</non_inferiority_desc>
            <p_value>0.7809</p_value>
            <p_value_desc>This p value is for the hypothesis of superiority</p_value_desc>
            <method>Mixed Model Repeated Measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.03</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.09</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.21</ci_lower_limit>
            <ci_upper_limit>0.15</ci_upper_limit>
            <estimate_desc>Mean difference=Saxagliptin - Acarbose</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion (%) of Patients With Any GI Adverse Events</title>
        <description>Secondary Objective: Assessment of any gastrointestinal adverse events of saxagliptin versus acarbose. by measure proportion (%) of patients with any gastrointestinal adverse events.</description>
        <time_frame>24 weeks</time_frame>
        <population>The Full analysis set included all randomized subjects who took at least 1 randomized IP dose, and had at least 1 non-missing baseline and 1 post-baseline efficacy data assessments.</population>
        <group_list>
          <group group_id="O1">
            <title>Saxagliptin</title>
            <description>The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.</description>
          </group>
          <group group_id="O2">
            <title>Acarbose</title>
            <description>Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion (%) of Patients With Any GI Adverse Events</title>
          <description>Secondary Objective: Assessment of any gastrointestinal adverse events of saxagliptin versus acarbose. by measure proportion (%) of patients with any gastrointestinal adverse events.</description>
          <population>The Full analysis set included all randomized subjects who took at least 1 randomized IP dose, and had at least 1 non-missing baseline and 1 post-baseline efficacy data assessments.</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="238"/>
                <count group_id="O2" value="243"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>NO</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.5"/>
                    <measurement group_id="O2" value="75.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>YES</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.5"/>
                    <measurement group_id="O2" value="24.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Stratefied by the baseline disease severity (HbA1c &lt; 8.0% and ≥ 8.0%)</method_desc>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>0.22</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.12</ci_lower_limit>
            <ci_upper_limit>0.39</ci_upper_limit>
            <estimate_desc>RR = Saxagliptin/Acarbose</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion (%) of Patients Achieving a Therapeutic Glycemic Response Defined as HbA1c&lt;7.0%</title>
        <description>Secondary Objective: Effects of saxagliptin versus acarbose on the additional parameters, by measure proportion (%) of patients achieving a therapeutic glycemic response defined as HbA1c&lt;7.0%</description>
        <time_frame>24 weeks</time_frame>
        <population>The Full analysis set included all randomized subjects who took at least 1 randomized IP dose, and had at least 1 non-missing baseline and 1 post-baseline efficacy data assessments.</population>
        <group_list>
          <group group_id="O1">
            <title>Saxagliptin</title>
            <description>The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.</description>
          </group>
          <group group_id="O2">
            <title>Acarbose</title>
            <description>Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion (%) of Patients Achieving a Therapeutic Glycemic Response Defined as HbA1c&lt;7.0%</title>
          <description>Secondary Objective: Effects of saxagliptin versus acarbose on the additional parameters, by measure proportion (%) of patients achieving a therapeutic glycemic response defined as HbA1c&lt;7.0%</description>
          <population>The Full analysis set included all randomized subjects who took at least 1 randomized IP dose, and had at least 1 non-missing baseline and 1 post-baseline efficacy data assessments.</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="230"/>
                <count group_id="O2" value="229"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.3"/>
                    <measurement group_id="O2" value="41.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.5044</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>stratefied by baseline disease severity (HbA1c&lt;8%, &gt;=8%)</method_desc>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>0.92</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.74</ci_lower_limit>
            <ci_upper_limit>1.15</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion (%) of Patients Achieving HbA1c&lt;7.0% Without GI Adverse Events</title>
        <description>Secondary Objective: Assessment of any gastrointestinal adverse events of saxagliptin versus acarbose. by measure proportion (%) of patients achieving HbA1c&lt;7.0% without GI adverse events.</description>
        <time_frame>Whole study duration</time_frame>
        <population>The Full analysis set included all randomized subjects who took at least 1 randomized IP dose, and had at least 1 non-missing baseline and 1 post-baseline efficacy data assessments.</population>
        <group_list>
          <group group_id="O1">
            <title>Saxagliptin</title>
            <description>The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.</description>
          </group>
          <group group_id="O2">
            <title>Acarbose</title>
            <description>Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion (%) of Patients Achieving HbA1c&lt;7.0% Without GI Adverse Events</title>
          <description>Secondary Objective: Assessment of any gastrointestinal adverse events of saxagliptin versus acarbose. by measure proportion (%) of patients achieving HbA1c&lt;7.0% without GI adverse events.</description>
          <population>The Full analysis set included all randomized subjects who took at least 1 randomized IP dose, and had at least 1 non-missing baseline and 1 post-baseline efficacy data assessments.</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="230"/>
                <count group_id="O2" value="229"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.0"/>
                    <measurement group_id="O2" value="28.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0518</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Stratefied by the baseline disease severity (HbA1c &lt; 8.0% and ≥ 8.0%)</method_desc>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>1.28</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.98</ci_lower_limit>
            <ci_upper_limit>1.67</ci_upper_limit>
            <estimate_desc>RR = Saxagliptin/Acarbose</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Fasting Plasma Glucose (FPG)</title>
        <description>Secondary objective: Effects of saxagliptin versus acarbose on the additional parameters, by measure change from baseline in fasting plasma glucose, 2h postprandial glucose, β-cell function, body weight at week 24</description>
        <time_frame>From baseline to 24 week</time_frame>
        <population>The Full analysis set included all randomized subjects who took at least 1 randomized IP dose, and had at least 1 non-missing baseline and 1 post-baseline efficacy data assessments.</population>
        <group_list>
          <group group_id="O1">
            <title>Saxagliptin</title>
            <description>The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.</description>
          </group>
          <group group_id="O2">
            <title>Acarbose</title>
            <description>Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Fasting Plasma Glucose (FPG)</title>
          <description>Secondary objective: Effects of saxagliptin versus acarbose on the additional parameters, by measure change from baseline in fasting plasma glucose, 2h postprandial glucose, β-cell function, body weight at week 24</description>
          <population>The Full analysis set included all randomized subjects who took at least 1 randomized IP dose, and had at least 1 non-missing baseline and 1 post-baseline efficacy data assessments.</population>
          <units>mmol/l</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="238"/>
                <count group_id="O2" value="243"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.99" spread="0.13"/>
                    <measurement group_id="O2" value="-1.01" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.8915</p_value>
            <method>Mixed Model Repeated Measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.02</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.18</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.33</ci_lower_limit>
            <ci_upper_limit>0.38</ci_upper_limit>
            <estimate_desc>Mean difference=Saxagliptin - Acarbose</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in 2H Postprandial Glucose (2HPPG)</title>
        <description>Secondary objective: Effects of saxagliptin versus acarbose on the additional parameters, by measure change from baseline in fasting plasma glucose, 2h postprandial glucose, β-cell function, body weight at week 24</description>
        <time_frame>From baseline to 24 week</time_frame>
        <population>The Full analysis set included all randomized subjects who took at least 1 randomized IP dose, and had at least 1 non-missing baseline and 1 post-baseline efficacy data assessments.</population>
        <group_list>
          <group group_id="O1">
            <title>Saxagliptin</title>
            <description>The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.</description>
          </group>
          <group group_id="O2">
            <title>Acarbose</title>
            <description>Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in 2H Postprandial Glucose (2HPPG)</title>
          <description>Secondary objective: Effects of saxagliptin versus acarbose on the additional parameters, by measure change from baseline in fasting plasma glucose, 2h postprandial glucose, β-cell function, body weight at week 24</description>
          <population>The Full analysis set included all randomized subjects who took at least 1 randomized IP dose, and had at least 1 non-missing baseline and 1 post-baseline efficacy data assessments.</population>
          <units>mmol/l</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="227"/>
                <count group_id="O2" value="232"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.77" spread="0.176"/>
                    <measurement group_id="O2" value="-1.07" spread="0.174"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.2248</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.30</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.249</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.186</ci_lower_limit>
            <ci_upper_limit>0.791</ci_upper_limit>
            <estimate_desc>Mean difference=Saxagliptin - Acarbose</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in HOMA-β</title>
        <description>Secondary objective: Effects of saxagliptin versus acarbose on the additional parameters, by measure change from baseline in fasting plasma glucose, 2h postprandial glucose, β-cell function was estimated by the Homeostasis model assessment-β (HOMA-β), which was defined as fasting insulin (mU/mL) x 20 / (fasting glucose (mmol/mL) - 3.5, body weight at week 24</description>
        <time_frame>From baseline to 24 week</time_frame>
        <population>The Full analysis set included all randomized subjects who took at least 1 randomized IP dose, and had at least 1 non-missing baseline and 1 post-baseline efficacy data assessments.</population>
        <group_list>
          <group group_id="O1">
            <title>Saxagliptin</title>
            <description>The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.</description>
          </group>
          <group group_id="O2">
            <title>Acarbose</title>
            <description>Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in HOMA-β</title>
          <description>Secondary objective: Effects of saxagliptin versus acarbose on the additional parameters, by measure change from baseline in fasting plasma glucose, 2h postprandial glucose, β-cell function was estimated by the Homeostasis model assessment-β (HOMA-β), which was defined as fasting insulin (mU/mL) x 20 / (fasting glucose (mmol/mL) - 3.5, body weight at week 24</description>
          <population>The Full analysis set included all randomized subjects who took at least 1 randomized IP dose, and had at least 1 non-missing baseline and 1 post-baseline efficacy data assessments.</population>
          <units>mU/mmol</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="227"/>
                <count group_id="O2" value="225"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.56" spread="5.932"/>
                    <measurement group_id="O2" value="13.08" spread="5.958"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.3739</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>7.48</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>8.407</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.039</ci_lower_limit>
            <ci_upper_limit>24.005</ci_upper_limit>
            <estimate_desc>Mean difference=Saxagliptin - Acarbose</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Body Weight</title>
        <description>Secondary objective: Effects of saxagliptin versus acarbose on the additional parameters, by measure change from baseline in fasting plasma glucose, 2h postprandial glucose, β-cell function, body weight at week 24</description>
        <time_frame>From baseline to 24 week</time_frame>
        <population>The Full analysis set included all randomized subjects who took at least 1 randomized IP dose, and had at least 1 non-missing baseline and 1 post-baseline efficacy data assessments.</population>
        <group_list>
          <group group_id="O1">
            <title>Saxagliptin</title>
            <description>The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.</description>
          </group>
          <group group_id="O2">
            <title>Acarbose</title>
            <description>Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Body Weight</title>
          <description>Secondary objective: Effects of saxagliptin versus acarbose on the additional parameters, by measure change from baseline in fasting plasma glucose, 2h postprandial glucose, β-cell function, body weight at week 24</description>
          <population>The Full analysis set included all randomized subjects who took at least 1 randomized IP dose, and had at least 1 non-missing baseline and 1 post-baseline efficacy data assessments.</population>
          <units>kg</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="238"/>
                <count group_id="O2" value="243"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.36" spread="0.18"/>
                    <measurement group_id="O2" value="-2.05" spread="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0078</p_value>
            <method>Mixed Model Repeated Measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.69</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.26</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.18</ci_lower_limit>
            <ci_upper_limit>1.19</ci_upper_limit>
            <estimate_desc>Mean difference=Saxagliptin - Acarbose</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse Events were collected from time of signature of informed consent, throughout the treatment period. That was about 28 weeks for every subject.</time_frame>
      <desc>Unresolved AEs unresolved at the subject's last visit were followed up by the Investigator for as long as medically indicated, but without furtherrecording in the CRF. Below reported AEs were Treatment Emergent Adverse Events which were AEs from the first dose of investigational product to the end of follow-up.</desc>
      <group_list>
        <group group_id="E1">
          <title>Saxagliptin</title>
          <description>The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.</description>
        </group>
        <group group_id="E2">
          <title>Acarbose</title>
          <description>Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDra 18.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="241"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="244"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="244"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <description>The SOC term was reported as &quot;General disorders and administration site conditions&quot; in study results.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="244"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>cholecystitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="244"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="244"/>
              </event>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="244"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>herpes zoster</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="244"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="244"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="244"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic kidney disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="244"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDra 18.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="27" subjects_at_risk="241"/>
                <counts group_id="E2" subjects_affected="74" subjects_at_risk="244"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="241"/>
                <counts group_id="E2" events="25" subjects_affected="25" subjects_at_risk="244"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="18" subjects_affected="18" subjects_at_risk="244"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperlipidaemia</sub_title>
                <counts group_id="E1" events="15" subjects_affected="15" subjects_at_risk="241"/>
                <counts group_id="E2" events="14" subjects_affected="14" subjects_at_risk="244"/>
              </event>
              <event>
                <sub_title>Hyperlipidaemia</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="241"/>
                <counts group_id="E2" events="17" subjects_affected="17" subjects_at_risk="244"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Xia, Zhang</name_or_title>
      <organization>ASTRAZENECA INVESTMENT (CHINA) CO., LTD.</organization>
      <phone>+86 21 6030 2288 ext 2035</phone>
      <email>Xia.Zhang@astrazeneca.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02243176
org study id: D1680L00018
nct id: NCT02243176
lead sponsor: 
has dmc: No
SMART Study - A 24-Week, Multicenter, Randomized, Parallel-group, Open-label, Active
      Controlled Phase IV Study to Assess the Efficacy, Safety and Tolerability of Saxagliptin
      Compared with Acarbose when in Combination with Metformin in Patients with Type 2 Diabetes
      Mellitus (T2D) Inadequately Controlled with Metformin Monotherapy
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Absolute Change From Baseline in HbA1c at Week 24 (DAO)
time frame: From baseline to 24 week
description: Primary Objective: Efficacy of saxagliptin plus metformin on glycemic control compared with acarbose plus metformin in patients with T2D inadequately controlled with metformin. By Measure absolute change from baseline in HbA1c at Week 24
measure: Absolute Change From Baseline in HbA1c at Week 24 (DAO)
time frame: From baseline to 24 week
description: The primary endpoint was analyzed based on Per protocol analysis set as the supportive analysis.
measure: Proportion (%) of Patients With Any GI Adverse Events
time frame: 24 weeks
description: Secondary Objective: Assessment of any gastrointestinal adverse events of saxagliptin versus acarbose. by measure proportion (%) of patients with any gastrointestinal adverse events.
measure: Proportion (%) of Patients Achieving a Therapeutic Glycemic Response Defined as HbA1c<7.0%
time frame: 24 weeks
description: Secondary Objective: Effects of saxagliptin versus acarbose on the additional parameters, by measure proportion (%) of patients achieving a therapeutic glycemic response defined as HbA1c<7.0%
measure: Proportion (%) of Patients Achieving HbA1c<7.0% Without GI Adverse Events
time frame: Whole study duration
description: Secondary Objective: Assessment of any gastrointestinal adverse events of saxagliptin versus acarbose. by measure proportion (%) of patients achieving HbA1c<7.0% without GI adverse events.
measure: Change From Baseline in Fasting Plasma Glucose (FPG)
time frame: From baseline to 24 week
description: Secondary objective: Effects of saxagliptin versus acarbose on the additional parameters, by measure change from baseline in fasting plasma glucose, 2h postprandial glucose, β-cell function, body weight at week 24
measure: Change From Baseline in 2H Postprandial Glucose (2HPPG)
time frame: From baseline to 24 week
description: Secondary objective: Effects of saxagliptin versus acarbose on the additional parameters, by measure change from baseline in fasting plasma glucose, 2h postprandial glucose, β-cell function, body weight at week 24
measure: Change From Baseline in HOMA-β
time frame: From baseline to 24 week
description: Secondary objective: Effects of saxagliptin versus acarbose on the additional parameters, by measure change from baseline in fasting plasma glucose, 2h postprandial glucose, β-cell function was estimated by the Homeostasis model assessment-β (HOMA-β), which was defined as fasting insulin (mU/mL) x 20 / (fasting glucose (mmol/mL) - 3.5, body weight at week 24
measure: Change From Baseline in Body Weight
time frame: From baseline to 24 week
description: Secondary objective: Effects of saxagliptin versus acarbose on the additional parameters, by measure change from baseline in fasting plasma glucose, 2h postprandial glucose, β-cell function, body weight at week 24
arm group label: Saxagliptin
arm group type: Experimental
description: The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.
arm group label: Acarbose
arm group type: Active Comparator
description: Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.
intervention type: Drug
intervention name: Saxagliptin
description: The dose of saxaglitpin will be 5mg oral qd.
arm group label: Saxagliptin
other name: Onglyza
intervention type: Drug
intervention name: Acarbose
description: Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose.
arm group label: Acarbose
other name: Glucobay
criteria: 
gender: All
minimum age: 18 Years
maximum age: 150 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Saxagliptin
mesh term: Acarbose
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 