<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/NCT03259789</url>
  </required_header>
  <id_info>
    <org_study_id>THR-1442-C-419</org_study_id>
    <nct_id>NCT03259789</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Bexagliflozin Compared to Placebo as Add-on Therapy to Metformin in Type 2 Diabetes Subjects</brief_title>
  <official_title>A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Bexagliflozin in Subjects With Type 2 Diabetes Mellitus Who Are Not Adequately Controlled by Metformin Alone</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Theracos</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Theracos</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the effect of bexagliflozin compared to placebo&#xD;
      as an add-on therapy to metformin in lowering hemoglobin A1c (HbA1c) levels in subjects with&#xD;
      type 2 diabetes mellitus (T2DM).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Approximately 300 subjects with inadequately controlled T2DM on metformin were to be&#xD;
      recruited from the United States and Japan. Subjects were randomly assigned to receive&#xD;
      bexagliflozin tablets, 20 mg, or bexagliflozin tablets, placebo, in a ratio of 1:1 once daily&#xD;
      for 24 weeks. Subjects were to continue taking metformin for the duration of the study. The&#xD;
      study also enrolled 50 subjects with extremely poorly controlled T2DM on metformin to receive&#xD;
      open-label bexagliflozin tablets, 20 mg, for 24 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 28, 2017</start_date>
  <completion_date type="Actual">January 23, 2019</completion_date>
  <primary_completion_date type="Actual">January 23, 2019</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in HbA1c at Week 24 for Double-blind Group</measure>
    <time_frame>Baseline to week 24</time_frame>
    <description>HbA1c was obtained at baseline and at Week 24. The model-adjusted change from baseline was calculated using mixed-effects repeated measures analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in HbA1c at Week 24 for High Glycemic Group</measure>
    <time_frame>Baseline to week 24</time_frame>
    <description>The change in HbA1c from baseline at Week 24 in High Glycemic Group was calculated by subtracting the mean HbA1c at baseline from the mean HbA1c at Week 24</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 for Double-blind Group</measure>
    <time_frame>Baseline, up to 24 weeks</time_frame>
    <description>FPG was obtained at baseline and at Week 24. The model-adjusted change from baseline was calculated using mixed-effects repeated measures analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 for High Glycemic Group</measure>
    <time_frame>Baseline, up to 24 weeks</time_frame>
    <description>The change in FPG from baseline at Week 24 for High Glycemic Group was calculated by subtracting the mean FPG at baseline from the mean FPG at Week 24</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Systolic Blood Pressure (SBP) at Week 24</measure>
    <time_frame>Baseline to week 24</time_frame>
    <description>Changes from baseline at Week 24 in SBP for the double-blind group and high glycemic group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Subjects Achieving HbA1c &lt; 7% Over Time for Double-blind Group</measure>
    <time_frame>Baseline, up to 24 weeks</time_frame>
    <description>The proportion of subjects who achieved HbA1c &lt; 7% at 6, 12, 18 and 24 weeks were calculated based on the number of subjects with a value at each time point for each group. The model-adjusted proportion was calculated based on a logistic analysis using Generalized Estimating Equation (GEE) logistic regression that includes country, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate. An unstructured correlation structure will be used, or autoregressive if the model with the unstructured structure does not converge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Subjects Achieving HbA1c &lt; 7% Over Time for High Glycemic Group</measure>
    <time_frame>Baseline, up to 24 weeks</time_frame>
    <description>The proportion of subjects who achieved HbA1c &lt; 7% at 6, 12, 18 and 24 weeks were calculated based on the number of subjects with a value at each time point for each group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Body Mass From Baseline to Week 24 in Subjects With a BMI ≥ 25 kg/m2 for Double-blind Group</measure>
    <time_frame>Baseline to week 24</time_frame>
    <description>Changes in body mass from baseline to week 24 was calculated based on LS means for both bexagliflozin and placebo groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Body Mass From Baseline to Week 24 in Subjects With a BMI ≥ 25 kg/m2 for High Glycemic Group</measure>
    <time_frame>Baseline to week 24</time_frame>
    <description>The change in body mass from baseline at week 24 for High Glycemic group was calculated by subtracting the mean body mass at baseline from the mean body mass at week 24</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in HbA1c Over Time in Double-blind Treatment Group</measure>
    <time_frame>Baseline, up to 24 weeks</time_frame>
    <description>The change from baseline in HbA1c at 6, 12, 18 and 24 weeks was calculated based on the number of subjects with a value at each time point for each group. The model-adjusted change from baseline was calculated based on a mixed-effects repeated measures analysis that includes country, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in HbA1c Over Time Among Subjects Who Have Baseline HbA1c of &gt; 10.5% and ≤ 12.0%</measure>
    <time_frame>Baseline, up to 24 weeks</time_frame>
    <description>The change from baseline in HbA1c at 6, 12, 18 and 24 weeks was calculated based on the number of subjects with a value at each time point in High Glycemic Group.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">351</enrollment>
  <condition>Type2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Bexagliflozin tablets, 20 mg; Double-Blind</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Bexagliflozin tablets, Placebo; Double Blind</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Bexagliflozin Tablets, 20 mg; High Glycemic Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bexagliflozin tablets, 20 mg</intervention_name>
    <description>Each subject will receive bexagliflozin, 20 mg once daily for the duration of the study.</description>
    <arm_group_label>Bexagliflozin tablets, 20 mg; Double-Blind</arm_group_label>
    <other_name>EGT0001442, EGT0001474</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bexagliflozin tablets, placebo</intervention_name>
    <description>Each subject will receive placebo (inactive tablet) once daily for the duration of the study.</description>
    <arm_group_label>Bexagliflozin tablets, Placebo; Double Blind</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bexagliflozin tablets, 20 mg</intervention_name>
    <description>Each subject will receive bexagliflozin, 20 mg once daily for the duration of the study.</description>
    <arm_group_label>Bexagliflozin Tablets, 20 mg; High Glycemic Group</arm_group_label>
    <other_name>EGT0001442, EGT0001474</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        The subjects were required to meet the following criteria at the time of enrollment to be&#xD;
        eligible for the study:&#xD;
&#xD;
          1. Had been age ≥ 20 years at screening. Women of childbearing potential were required to&#xD;
             have tested negative for pregnancy and have agreed to abstinence or contraception for&#xD;
             the duration of the study to avoid any possible pregnancy. Females who were surgically&#xD;
             sterile (hysterectomy, oophorectomy) or postmenopausal (absence of menses greater than&#xD;
             12 months) were eligible if they had tested negative for pregnancy at screening.&#xD;
&#xD;
          2. a) Had a history of T2DM with an HbA1c level of ≥ 7.5% and ≤ 10.5% at screening, or b)&#xD;
             Had a history of T2DM with an HbA1c level of &gt;10.5% and ≤ 12.0% at screening&#xD;
&#xD;
          3. Had been prescribed a stable dose of metformin (≥1500 mg per day in the US or ≥ 1000&#xD;
             mg per day in Japan) as their sole anti-diabetic medication&#xD;
&#xD;
          4. Had a body mass index (BMI) ≤ 45 kg m-2&#xD;
&#xD;
          5. Had been able to comprehend and willing to provide written informed consent in&#xD;
             accordance with institutional and regulatory guidelines&#xD;
&#xD;
          6. Had no recent changes to their medications for hypertension or hyperlipidemia (if&#xD;
             applicable)&#xD;
&#xD;
          7. Had the ability to regularly self-administer medication, as evidenced by consumption&#xD;
             of all, or at worst one less than all, doses of run-in medication prior to&#xD;
             randomization&#xD;
&#xD;
        Subjects who met any of the following criteria were to be excluded from the study:&#xD;
&#xD;
          1. Had a diagnosis of type 1 diabetes mellitus or maturity-onset diabetes of the young&#xD;
&#xD;
          2. Were pregnant or breastfeeding&#xD;
&#xD;
          3. Had one or more hemoglobin alleles that affect HbA1c measurement&#xD;
&#xD;
          4. Had a history of genitourinary tract infection (e.g., UTI, GMI, vaginitis, balanitis)&#xD;
             within 6 weeks of screening or a history of ≥ 3 genitourinary infections requiring&#xD;
             treatment within 6 months of screening&#xD;
&#xD;
          5. Had an estimated glomerular filtration rate (eGFR), as calculated by the modification&#xD;
             of diet in renal disease study equation (MDRD), &lt; 60 mL min-1 per 1.73 m2&#xD;
&#xD;
          6. Had a sitting systolic blood pressure &gt;180 mmHg or a sitting diastolic blood pressure&#xD;
             &gt; 110 mmHg at screening&#xD;
&#xD;
          7. Had exposure to hypoglycemic agent(s) other than metformin during the 8 weeks prior to&#xD;
             screening&#xD;
&#xD;
          8. Had a history of illicit drug use or alcohol abuse in the past 2 years&#xD;
&#xD;
          9. Had a life expectancy &lt; 2 years&#xD;
&#xD;
         10. Had a diagnosis of New York Heart Association (NYHA) Class IV heart failure within 3&#xD;
             months of screening&#xD;
&#xD;
         11. Had experienced an MI, unstable angina, stroke, or hospitalization for heart failure&#xD;
             within 3 months of screening&#xD;
&#xD;
         12. Had exposure to an investigational drug within 30 days&#xD;
&#xD;
         13. Had a previous exposure to bexagliflozin or EGT0001474&#xD;
&#xD;
         14. Had a history of SGLT2 inhibitor treatment&#xD;
&#xD;
         15. Were participating in another interventional trial&#xD;
&#xD;
         16. Were not able to comply with the study scheduled visits&#xD;
&#xD;
         17. Had any condition, disease, disorder, or clinically relevant abnormality that, in the&#xD;
             opinion of the primary investigator, would jeopardize the subject's appropriate&#xD;
             participation in this study or obscure the effects of treatment&#xD;
&#xD;
         18. Had an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 × ULN&#xD;
             or total bilirubin ≥ 1.5 × ULN at 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>J, Paul Lock, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>Theracos</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Research Site 1232</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site 1378</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site 1269</name>
      <address>
        <city>Foley</city>
        <state>Alabama</state>
        <zip>36535</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site 1363</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site 1381</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site 1375</name>
      <address>
        <city>North Hollywood</city>
        <state>California</state>
        <zip>91606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site 1365</name>
      <address>
        <city>Norwalk</city>
        <state>California</state>
        <zip>90650</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site 1382</name>
      <address>
        <city>Norwalk</city>
        <state>Connecticut</state>
        <zip>06851</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site 1372</name>
      <address>
        <city>Hollywood</city>
        <state>Florida</state>
        <zip>33024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site 1362</name>
      <address>
        <city>Palm Springs</city>
        <state>Florida</state>
        <zip>33461</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site 1373</name>
      <address>
        <city>Pembroke Pines</city>
        <state>Florida</state>
        <zip>33026</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site 1376</name>
      <address>
        <city>Nampa</city>
        <state>Idaho</state>
        <zip>83686</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site 1366</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60602</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site 1294</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site 1374</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site 1370</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site 1009</name>
      <address>
        <city>Berlin</city>
        <state>New Jersey</state>
        <zip>08009</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site 1037</name>
      <address>
        <city>Trenton</city>
        <state>New Jersey</state>
        <zip>08611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site 1286</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site 1275</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site 1368</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10036</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site 1019</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site 1379</name>
      <address>
        <city>Gonzales</city>
        <state>Texas</state>
        <zip>78629</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site 1369</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77051</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site 1371</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site 1360</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78258</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site 6048</name>
      <address>
        <city>Nagoya</city>
        <state>Aichi</state>
        <zip>456-0058</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site 6050</name>
      <address>
        <city>Sapporo</city>
        <state>Hokkaido</state>
        <zip>003-0023</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site 6041</name>
      <address>
        <city>Koga</city>
        <state>Ibaraki</state>
        <zip>306-0232</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site 6029</name>
      <address>
        <city>Atsugi</city>
        <state>Kanagawa</state>
        <zip>243-0035</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site 6051</name>
      <address>
        <city>Kamakura</city>
        <state>Kanagawa</state>
        <zip>547-0055</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site 6020</name>
      <address>
        <city>Yokohama</city>
        <state>Kanagawa</state>
        <zip>221-080</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site 6055</name>
      <address>
        <city>Tokyo</city>
        <state>Meguro</state>
        <zip>153-0053</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site 6046</name>
      <address>
        <city>Higashiosaka</city>
        <state>Osaka</state>
        <zip>577-0803</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site 6033</name>
      <address>
        <city>Kashiwara</city>
        <state>Osaka</state>
        <zip>582-0005</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site 6013</name>
      <address>
        <city>Toyonaka</city>
        <state>Osaka</state>
        <zip>560-0082</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site 6052</name>
      <address>
        <city>Kawaguchi</city>
        <state>Saitama</state>
        <zip>332-0012</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site 6053</name>
      <address>
        <city>Shimotsuke</city>
        <state>Tochigi</state>
        <zip>329-0433</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site 6040</name>
      <address>
        <city>Fukuoka</city>
        <zip>819-0006</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site 6043</name>
      <address>
        <city>Kyoto</city>
        <zip>600-8898</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site 6015</name>
      <address>
        <city>Osaka</city>
        <zip>536-0008</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site 6045</name>
      <address>
        <city>Tokyo</city>
        <zip>108-0075</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Site 6047</name>
      <address>
        <city>Tokyo</city>
        <zip>166-0003</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <results_first_submitted>April 5, 2021</results_first_submitted>
  <results_first_submitted_qc>July 6, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">July 7, 2021</results_first_posted>
  <disposition_first_submitted>January 24, 2019</disposition_first_submitted>
  <disposition_first_submitted_qc>July 6, 2021</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">July 7, 2021</disposition_first_posted>
  <last_update_submitted>July 6, 2021</last_update_submitted>
  <last_update_submitted_qc>July 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bexagliflozin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 26, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/89/NCT03259789/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 15, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/89/NCT03259789/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Double-blind Group: Bexagliflozin 20 mg</title>
          <description>Each subject will receive bexagliflozin, 20 mg, once daily and open-labeled metformin background medication during the entire study at a stable dose and frequency.</description>
        </group>
        <group group_id="P2">
          <title>Double-blind Group: Placebo</title>
          <description>Each subject will receive placebo (inactive tablet) once daily and open-labeled metformin background medication during the entire study at a stable dose and frequency.</description>
        </group>
        <group group_id="P3">
          <title>High Glycemic Group</title>
          <description>Each subject will receive Bexagliflozin tablet, 20 mg, once daily and open-labeled metformin background medication during the entire study at a stable dose and frequency.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="158"/>
                <participants group_id="P2" count="159"/>
                <participants group_id="P3" count="34"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="141"/>
                <participants group_id="P2" count="142"/>
                <participants group_id="P3" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="17"/>
                <participants group_id="P3" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Double-blind Group: Bexagliflozin 20 mg</title>
          <description>Each subject will receive bexagliflozin, 20 mg, once daily and open-labeled metformin background medication during the entire study at a stable dose and frequency.</description>
        </group>
        <group group_id="B2">
          <title>Double-blind Group: Placebo</title>
          <description>Each subject will receive placebo (inactive tablet) once daily and open-labeled metformin background medication during the entire study at a stable dose and frequency.</description>
        </group>
        <group group_id="B3">
          <title>High Glycemic Group</title>
          <description>Each subject will receive Bexagliflozin, 20 mg, once daily and open-labeled metformin background medication during the entire study at a stable dose and frequency.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="158"/>
            <count group_id="B2" value="159"/>
            <count group_id="B3" value="34"/>
            <count group_id="B4" value="351"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>Total number of participants for Double-blind group is 317. The number of participants for High Glycemic group is 34.</description>
          <population>For the Double-blind group, the High Glycemic group is excluded. Therefore, the number of participants analyzed is 317. Conversely, for the High Glycemic group, the Double-blind group is excluded. Therefore, the number of participants analyzed is 34.</population>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Double-blind Group</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="158"/>
                    <count group_id="B2" value="159"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="317"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56.0" spread="10.05"/>
                    <measurement group_id="B2" value="55.6" spread="11.18"/>
                    <measurement group_id="B4" value="55.8" spread="10.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>High Glycemic Group</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="34"/>
                    <count group_id="B4" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="52.1" spread="8.59"/>
                    <measurement group_id="B4" value="52.1" spread="8.59"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="158"/>
                    <count group_id="B2" value="159"/>
                    <count group_id="B3" value="34"/>
                    <count group_id="B4" value="351"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                    <measurement group_id="B2" value="65"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="138"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="100"/>
                    <measurement group_id="B2" value="94"/>
                    <measurement group_id="B3" value="19"/>
                    <measurement group_id="B4" value="213"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="158"/>
                    <count group_id="B2" value="159"/>
                    <count group_id="B3" value="34"/>
                    <count group_id="B4" value="351"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="76"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="123"/>
                    <measurement group_id="B2" value="127"/>
                    <measurement group_id="B3" value="25"/>
                    <measurement group_id="B4" value="275"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="158"/>
                    <count group_id="B2" value="159"/>
                    <count group_id="B3" value="34"/>
                    <count group_id="B4" value="351"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="78"/>
                    <measurement group_id="B2" value="79"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="166"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="67"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                    <measurement group_id="B2" value="48"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="110"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="158"/>
                    <count group_id="B2" value="159"/>
                    <count group_id="B3" value="34"/>
                    <count group_id="B4" value="351"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="83"/>
                    <measurement group_id="B2" value="83"/>
                    <measurement group_id="B3" value="27"/>
                    <measurement group_id="B4" value="193"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Japan</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="158"/>
                    <count group_id="B2" value="159"/>
                    <count group_id="B3" value="34"/>
                    <count group_id="B4" value="351"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="75"/>
                    <measurement group_id="B2" value="76"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="158"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <description>Total number of participants for Double-blind group is 317. The number of subjects for High Glycemic group is 34.</description>
          <population>For the Double-blind group, the High Glycemic group is excluded. Therefore, the number of participants analyzed is 317. Conversely, for the High Glycemic group, the Double-blind group is excluded. Therefore, the number of participants analyzed is 34.</population>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Double-blind Group</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="158"/>
                    <count group_id="B2" value="159"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="317"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="168.4" spread="9.71"/>
                    <measurement group_id="B2" value="167.3" spread="9.55"/>
                    <measurement group_id="B4" value="167.8" spread="9.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>High Glycemic Group</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="34"/>
                    <count group_id="B4" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="169.4" spread="9.34"/>
                    <measurement group_id="B4" value="169.4" spread="9.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Weight</title>
          <description>Total number of participants for Double-blind group is 317. The number of participants for High Glycemic group is 34.</description>
          <population>For the Double-blind group, the High Glycemic group is excluded. Therefore, the number of participants analyzed is 317. Conversely, for the High Glycemic group, the Double-blind group is excluded. Therefore, the number of participants analyzed is 34.</population>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Double-blind Group</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="158"/>
                    <count group_id="B2" value="159"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="317"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="84.58" spread="21.989"/>
                    <measurement group_id="B2" value="84.44" spread="20.928"/>
                    <measurement group_id="B4" value="84.51" spread="21.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>High Glycemic Group</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="34"/>
                    <count group_id="B4" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="87.28" spread="17.759"/>
                    <measurement group_id="B4" value="87.28" spread="17.759"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <description>Total number of participants for Double-blind group is 317. The number of participants for High Glycemic group is 34.</description>
          <population>For the Double-blind group, the High Glycemic group is excluded. Therefore, the number of participants analyzed is 317. Conversely, for the High Glycemic group, the Double-blind group is excluded. Therefore, the number of participants analyzed is 34.</population>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Double-blind Group</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="158"/>
                    <count group_id="B2" value="159"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="317"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29.67" spread="6.45"/>
                    <measurement group_id="B2" value="29.99" spread="6.342"/>
                    <measurement group_id="B4" value="29.83" spread="6.388"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>High Glycemic Group</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="34"/>
                    <count group_id="B4" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="30.37" spread="5.558"/>
                    <measurement group_id="B4" value="30.37" spread="5.558"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in HbA1c at Week 24 for Double-blind Group</title>
        <description>HbA1c was obtained at baseline and at Week 24. The model-adjusted change from baseline was calculated using mixed-effects repeated measures analysis.</description>
        <time_frame>Baseline to week 24</time_frame>
        <population>The intention-to-treat (ITT) population was used for the primary analysis. Subjects with a value at baseline and at week 24 were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Double-blind Group: Bexagliflozin 20 mg</title>
            <description>Each subject will receive bexagliflozin, 20 mg, once daily and open-labeled metformin background medication during the entire study at a stable dose and frequency.</description>
          </group>
          <group group_id="O2">
            <title>Double-blind Group: Placebo</title>
            <description>Each subject will receive placebo (inactive tablet) once daily and open-labeled metformin background medication during the entire study at a stable dose and frequency.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in HbA1c at Week 24 for Double-blind Group</title>
          <description>HbA1c was obtained at baseline and at Week 24. The model-adjusted change from baseline was calculated using mixed-effects repeated measures analysis.</description>
          <population>The intention-to-treat (ITT) population was used for the primary analysis. Subjects with a value at baseline and at week 24 were analyzed.</population>
          <units>percentage of 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="142"/>
                <count group_id="O2" value="145"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.09" spread="0.076"/>
                    <measurement group_id="O2" value="-0.56" spread="0.075"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.0001</p_value>
            <method>Mixed-effects repeated measures</method>
            <method_desc>Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates</method_desc>
            <param_type>Difference of LS Means</param_type>
            <param_value>-0.53</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>-0.32</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in HbA1c at Week 24 for High Glycemic Group</title>
        <description>The change in HbA1c from baseline at Week 24 in High Glycemic Group was calculated by subtracting the mean HbA1c at baseline from the mean HbA1c at Week 24</description>
        <time_frame>Baseline to week 24</time_frame>
        <population>The intention-to-treat (ITT) population was used for the primary analysis. Subjects with a value at baseline and at week 24 were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>High Glycemic Group</title>
            <description>Each subject will receive Bexagliflozin, 20 mg, once daily and open-labeled metformin background medication during the entire study at a stable dose and frequency.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in HbA1c at Week 24 for High Glycemic Group</title>
          <description>The change in HbA1c from baseline at Week 24 in High Glycemic Group was calculated by subtracting the mean HbA1c at baseline from the mean HbA1c at Week 24</description>
          <population>The intention-to-treat (ITT) population was used for the primary analysis. Subjects with a value at baseline and at week 24 were analyzed.</population>
          <units>percentage of HbA1c</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.82" spread="1.084"/>
                  </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 for Double-blind Group</title>
        <description>FPG was obtained at baseline and at Week 24. The model-adjusted change from baseline was calculated using mixed-effects repeated measures analysis.</description>
        <time_frame>Baseline, up to 24 weeks</time_frame>
        <population>ITT population was used for the analysis. Subjects with a value at baseline and at week 24 were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Double-blind Group: Bexagliflozin 20 mg</title>
            <description>Each subject will receive bexagliflozin, 20 mg, once daily and open-labeled metformin background medication during the entire study at a stable dose and frequency.</description>
          </group>
          <group group_id="O2">
            <title>Double-blind Group: Placebo</title>
            <description>Each subject will receive placebo (inactive tablet) once daily and open-labeled metformin background medication during the entire study at a stable dose and frequency.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 for Double-blind Group</title>
          <description>FPG was obtained at baseline and at Week 24. The model-adjusted change from baseline was calculated using mixed-effects repeated measures analysis.</description>
          <population>ITT population was used for the analysis. Subjects with a value at baseline and at week 24 were analyzed.</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="142"/>
                <count group_id="O2" value="145"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.51" spread="0.174"/>
                    <measurement group_id="O2" value="-1.16" spread="0.173"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.0001</p_value>
            <method>Mixed-effects repeated measures</method>
            <method_desc>Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates</method_desc>
            <param_type>Difference of LS Means</param_type>
            <param_value>-1.35</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.83</ci_lower_limit>
            <ci_upper_limit>-0.86</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 for High Glycemic Group</title>
        <description>The change in FPG from baseline at Week 24 for High Glycemic Group was calculated by subtracting the mean FPG at baseline from the mean FPG at Week 24</description>
        <time_frame>Baseline, up to 24 weeks</time_frame>
        <population>ITT population was used for the analysis. Subjects with a value at baseline and at week 24 were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>High Glycemic Group</title>
            <description>Each subject will receive Bexagliflozin, 20 mg, once daily and open-labeled metformin background medication during the entire study at a stable dose and frequency.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 for High Glycemic Group</title>
          <description>The change in FPG from baseline at Week 24 for High Glycemic Group was calculated by subtracting the mean FPG at baseline from the mean FPG at Week 24</description>
          <population>ITT population was used for the analysis. Subjects with a value at baseline and at week 24 were analyzed.</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.98" spread="3.437"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Systolic Blood Pressure (SBP) at Week 24</title>
        <description>Changes from baseline at Week 24 in SBP for the double-blind group and high glycemic group</description>
        <time_frame>Baseline to week 24</time_frame>
        <population>The ITT population was used for the analysis. Subjects with a value at baseline and at the specific visit were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Double-blind Group: Bexagliflozin 20 mg</title>
            <description>Each subject will receive bexagliflozin, 20 mg, once daily and open-labeled metformin background medication during the entire study at a stable dose and frequency.</description>
          </group>
          <group group_id="O2">
            <title>Double-blind Group: Placebo</title>
            <description>Each subject will receive placebo (inactive tablet) once daily and open-labeled metformin background medication during the entire study at a stable dose and frequency.</description>
          </group>
          <group group_id="O3">
            <title>High Glycemic Group</title>
            <description>Each subject will receive Bexagliflozin, 20 mg, once daily and open-labeled metformin background medication during the entire study at a stable dose and frequency.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Systolic Blood Pressure (SBP) at Week 24</title>
          <description>Changes from baseline at Week 24 in SBP for the double-blind group and high glycemic group</description>
          <population>The ITT population was used for the analysis. Subjects with a value at baseline and at the specific visit were analyzed.</population>
          <units>mm Hg</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="143"/>
                <count group_id="O2" value="145"/>
                <count group_id="O3" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.03" spread="0.993"/>
                    <measurement group_id="O2" value="2.04" spread="0.987"/>
                    <measurement group_id="O3" value="-8.19" spread="14.882"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.0001</p_value>
            <method>Mixed-effects repeated measures</method>
            <method_desc>Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates</method_desc>
            <param_type>Difference of LS Means</param_type>
            <param_value>-7.07</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.83</ci_lower_limit>
            <ci_upper_limit>-4.32</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Subjects Achieving HbA1c &lt; 7% Over Time for Double-blind Group</title>
        <description>The proportion of subjects who achieved HbA1c &lt; 7% at 6, 12, 18 and 24 weeks were calculated based on the number of subjects with a value at each time point for each group. The model-adjusted proportion was calculated based on a logistic analysis using Generalized Estimating Equation (GEE) logistic regression that includes country, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate. An unstructured correlation structure will be used, or autoregressive if the model with the unstructured structure does not converge.</description>
        <time_frame>Baseline, up to 24 weeks</time_frame>
        <population>The number of subjects in the ITT population with a value at baseline and at the specified visit was included. Model-adjusted proportion (LS proportion) and 95% confidence interval were reported for Double-blind Treatment Group.</population>
        <group_list>
          <group group_id="O1">
            <title>Double-blind Group: Bexagliflozin 20 mg</title>
            <description>Each subject will receive bexagliflozin, 20 mg, once daily and open-labeled metformin background medication during the entire study at a stable dose and frequency.</description>
          </group>
          <group group_id="O2">
            <title>Double-blind Group: Placebo</title>
            <description>Each subject will receive placebo (inactive tablet) once daily and open-labeled metformin background medication during the entire study at a stable dose and frequency.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Subjects Achieving HbA1c &lt; 7% Over Time for Double-blind Group</title>
          <description>The proportion of subjects who achieved HbA1c &lt; 7% at 6, 12, 18 and 24 weeks were calculated based on the number of subjects with a value at each time point for each group. The model-adjusted proportion was calculated based on a logistic analysis using Generalized Estimating Equation (GEE) logistic regression that includes country, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate. An unstructured correlation structure will be used, or autoregressive if the model with the unstructured structure does not converge.</description>
          <population>The number of subjects in the ITT population with a value at baseline and at the specified visit was included. Model-adjusted proportion (LS proportion) and 95% confidence interval were reported for Double-blind Treatment Group.</population>
          <units>Proportion of subjects</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="158"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="152"/>
                    <count group_id="O2" value="152"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.14" lower_limit="0.09" upper_limit="0.23"/>
                    <measurement group_id="O2" value="0.03" lower_limit="0.01" upper_limit="0.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="146"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.26" lower_limit="0.18" upper_limit="0.38"/>
                    <measurement group_id="O2" value="0.06" lower_limit="0.03" upper_limit="0.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 18</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="143"/>
                    <count group_id="O2" value="144"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.26" lower_limit="0.18" upper_limit="0.39"/>
                    <measurement group_id="O2" value="0.10" lower_limit="0.06" upper_limit="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="142"/>
                    <count group_id="O2" value="145"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.38" lower_limit="0.26" upper_limit="0.55"/>
                    <measurement group_id="O2" value="0.10" lower_limit="0.06" upper_limit="0.17"/>
                  </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>Odds ratio at Week 6 was calculated as the odds ratio of bexagliflozin group over placebo group.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0014</p_value>
            <p_value_desc>P-value is presented based on one-sided statistical tests using a 0.025 level of significance</p_value_desc>
            <method>Mixed-effects repeated measures</method>
            <method_desc>Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>4.69</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.70</ci_lower_limit>
            <ci_upper_limit>12.95</ci_upper_limit>
            <estimate_desc>The odds ratios of bexagliflozin group over the placebo group at each visit will be estimated from LS means based on the model with the corresponding p-values and their two-sided 95% CIs presented.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Odds ratio at Week 12 was calculated as the odds ratio of bexagliflozin group over placebo group.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0001</p_value>
            <p_value_desc>P-value is presented based on one-sided statistical tests using a 0.025 level of significance</p_value_desc>
            <method>Mixed-effects repeated measures</method>
            <method_desc>Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>4.18</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.96</ci_lower_limit>
            <ci_upper_limit>8.92</ci_upper_limit>
            <estimate_desc>The odds ratios of bexagliflozin group over the placebo group at each visit will be estimated from LS means based on the model with the corresponding p-values and their two-sided 95% CIs presented.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Odds ratio at Week 18 was calculated as the odds ratio of bexagliflozin group over placebo group.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0030</p_value>
            <p_value_desc>P-value is presented based on one-sided statistical tests using a 0.025 level of significance</p_value_desc>
            <method>Mixed-effects repeated measures</method>
            <method_desc>Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.57</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.31</ci_lower_limit>
            <ci_upper_limit>5.04</ci_upper_limit>
            <estimate_desc>The odds ratios of bexagliflozin group over the placebo group at each visit will be estimated from LS means based on the model with the corresponding p-values and their two-sided 95% CIs presented.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Odds ratio at Week 24 was calculated as the odds ratio of bexagliflozin group over placebo group.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.0001</p_value>
            <p_value_desc>P-value is presented based on one-sided statistical tests using a 0.025 level of significance</p_value_desc>
            <method>Mixed-effects repeated measures</method>
            <method_desc>Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>3.88</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.99</ci_lower_limit>
            <ci_upper_limit>7.58</ci_upper_limit>
            <estimate_desc>The odds ratios of bexagliflozin group over the placebo group at each visit will be estimated from LS means based on the model with the corresponding p-values and their two-sided 95% CIs presented.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Subjects Achieving HbA1c &lt; 7% Over Time for High Glycemic Group</title>
        <description>The proportion of subjects who achieved HbA1c &lt; 7% at 6, 12, 18 and 24 weeks were calculated based on the number of subjects with a value at each time point for each group.</description>
        <time_frame>Baseline, up to 24 weeks</time_frame>
        <population>The number of subjects in the ITT population with a value at baseline and at the specified visit was included. Proportion of subjects achieving HbA1c &lt; 7% was reported for High Glycemic Group without a 95% confidence interval.</population>
        <group_list>
          <group group_id="O1">
            <title>High Glycemic Group</title>
            <description>Each subject will receive Bexagliflozin, 20 mg, once daily and open-labeled metformin background medication during the entire study at a stable dose and frequency.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Subjects Achieving HbA1c &lt; 7% Over Time for High Glycemic Group</title>
          <description>The proportion of subjects who achieved HbA1c &lt; 7% at 6, 12, 18 and 24 weeks were calculated based on the number of subjects with a value at each time point for each group.</description>
          <population>The number of subjects in the ITT population with a value at baseline and at the specified visit was included. Proportion of subjects achieving HbA1c &lt; 7% was reported for High Glycemic Group without a 95% confidence interval.</population>
          <units>Proportion of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.065"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.097"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.138"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Body Mass From Baseline to Week 24 in Subjects With a BMI ≥ 25 kg/m2 for Double-blind Group</title>
        <description>Changes in body mass from baseline to week 24 was calculated based on LS means for both bexagliflozin and placebo groups.</description>
        <time_frame>Baseline to week 24</time_frame>
        <population>Subjects with a BMI &gt;= 25 kg/m2 at baseline in the ITT population were included. The number of subjects with a value at baseline and at week 24 was analyzed. Model-adjusted mean change (LS Mean) and standard error (SE) were reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Double-blind Group: Bexagliflozin 20 mg</title>
            <description>Each subject will receive bexagliflozin, 20 mg, once daily and open-labeled metformin background medication during the entire study at a stable dose and frequency.</description>
          </group>
          <group group_id="O2">
            <title>Double-blind Group: Placebo</title>
            <description>Each subject will receive placebo (inactive tablet) once daily and open-labeled metformin background medication during the entire study at a stable dose and frequency.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Body Mass From Baseline to Week 24 in Subjects With a BMI ≥ 25 kg/m2 for Double-blind Group</title>
          <description>Changes in body mass from baseline to week 24 was calculated based on LS means for both bexagliflozin and placebo groups.</description>
          <population>Subjects with a BMI &gt;= 25 kg/m2 at baseline in the ITT population were included. The number of subjects with a value at baseline and at week 24 was analyzed. Model-adjusted mean change (LS Mean) and standard error (SE) were reported.</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="119"/>
                <count group_id="O2" value="124"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.60" spread="0.348"/>
                    <measurement group_id="O2" value="-1.09" spread="0.336"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.0001</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates</method_desc>
            <param_type>Difference of LS Means</param_type>
            <param_value>-2.51</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.45</ci_lower_limit>
            <ci_upper_limit>-1.57</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Body Mass From Baseline to Week 24 in Subjects With a BMI ≥ 25 kg/m2 for High Glycemic Group</title>
        <description>The change in body mass from baseline at week 24 for High Glycemic group was calculated by subtracting the mean body mass at baseline from the mean body mass at week 24</description>
        <time_frame>Baseline to week 24</time_frame>
        <population>Subjects with a BMI &gt;= 25 kg/m2 at baseline in the ITT population were included. The number of subjects with a value at baseline and at week 24 was analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>High Glycemic Group</title>
            <description>Each subject will receive Bexagliflozin, 20 mg, once daily and open-labeled metformin background medication during the entire study at a stable dose and frequency.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Body Mass From Baseline to Week 24 in Subjects With a BMI ≥ 25 kg/m2 for High Glycemic Group</title>
          <description>The change in body mass from baseline at week 24 for High Glycemic group was calculated by subtracting the mean body mass at baseline from the mean body mass at week 24</description>
          <population>Subjects with a BMI &gt;= 25 kg/m2 at baseline in the ITT population were included. The number of subjects with a value at baseline and at week 24 was analyzed.</population>
          <units>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="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.40" spread="3.759"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in HbA1c Over Time in Double-blind Treatment Group</title>
        <description>The change from baseline in HbA1c at 6, 12, 18 and 24 weeks was calculated based on the number of subjects with a value at each time point for each group. The model-adjusted change from baseline was calculated based on a mixed-effects repeated measures analysis that includes country, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.</description>
        <time_frame>Baseline, up to 24 weeks</time_frame>
        <population>The Number Analyzed only includes the number of subjects with a value at baseline and at the specific visit. Model-adjusted mean change (LS Mean) and standard error (SE) were reported for Double-blind Treatment Group.</population>
        <group_list>
          <group group_id="O1">
            <title>Double-blind Group: Bexagliflozin 20 mg</title>
            <description>Each subject will receive bexagliflozin, 20 mg, once daily and open-labeled metformin background medication during the entire study at a stable dose and frequency.</description>
          </group>
          <group group_id="O2">
            <title>Double-blind Group: Placebo</title>
            <description>Each subject will receive placebo (inactive tablet) once daily and open-labeled metformin background medication during the entire study at a stable dose and frequency.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in HbA1c Over Time in Double-blind Treatment Group</title>
          <description>The change from baseline in HbA1c at 6, 12, 18 and 24 weeks was calculated based on the number of subjects with a value at each time point for each group. The model-adjusted change from baseline was calculated based on a mixed-effects repeated measures analysis that includes country, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.</description>
          <population>The Number Analyzed only includes the number of subjects with a value at baseline and at the specific visit. Model-adjusted mean change (LS Mean) and standard error (SE) were reported for Double-blind Treatment Group.</population>
          <units>percentage of 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="158"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="152"/>
                    <count group_id="O2" value="152"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.72" spread="0.065"/>
                    <measurement group_id="O2" value="-0.16" spread="0.065"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="146"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.97" spread="0.073"/>
                    <measurement group_id="O2" value="-0.31" spread="0.073"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 18</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="143"/>
                    <count group_id="O2" value="144"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.00" spread="0.072"/>
                    <measurement group_id="O2" value="-0.51" spread="0.072"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="142"/>
                    <count group_id="O2" value="145"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.09" spread="0.076"/>
                    <measurement group_id="O2" value="-0.56" spread="0.075"/>
                  </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>Model-adjusted change from baseline at week 6 was calculated as the difference in LS Mean between bexagliflozin group and placebo group.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.0001</p_value>
            <p_value_desc>P-value is presented based on one-sided statistical tests using a 0.025 level of significance</p_value_desc>
            <method>Mixed-effects repeated measures</method>
            <method_desc>Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates</method_desc>
            <param_type>Difference of LS Means</param_type>
            <param_value>-0.56</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>-0.38</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Model-adjusted change from baseline at week 12 was calculated as the difference in LS Mean between bexagliflozin group and placebo group.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.0001</p_value>
            <p_value_desc>P-value is presented based on one-sided statistical tests using a 0.025 level of significance</p_value_desc>
            <method>Mixed-effects repeated measures</method>
            <method_desc>Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates</method_desc>
            <param_type>Difference of LS Means</param_type>
            <param_value>-0.66</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.86</ci_lower_limit>
            <ci_upper_limit>-0.46</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Model-adjusted change from baseline at week 18 was calculated as the difference in LS Mean between bexagliflozin group and placebo group.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.0001</p_value>
            <p_value_desc>P-value is presented based on one-sided statistical tests using a 0.025 level of significance</p_value_desc>
            <method>Mixed-effects repeated measures</method>
            <method_desc>Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates</method_desc>
            <param_type>Difference of LS Means</param_type>
            <param_value>-0.50</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.69</ci_lower_limit>
            <ci_upper_limit>-0.30</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Model-adjusted change from baseline at week 24 was calculated as the difference in LS Mean between bexagliflozin group and placebo group.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.0001</p_value>
            <p_value_desc>P-value is presented based on one-sided statistical tests using a 0.025 level of significance</p_value_desc>
            <method>Mixed-effects repeated measures</method>
            <method_desc>Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates</method_desc>
            <param_type>Difference of LS Means</param_type>
            <param_value>-0.53</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>-0.32</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in HbA1c Over Time Among Subjects Who Have Baseline HbA1c of &gt; 10.5% and ≤ 12.0%</title>
        <description>The change from baseline in HbA1c at 6, 12, 18 and 24 weeks was calculated based on the number of subjects with a value at each time point in High Glycemic Group.</description>
        <time_frame>Baseline, up to 24 weeks</time_frame>
        <population>The Number Analyzed only includes the number of subjects with a value at baseline and at the specific visit.</population>
        <group_list>
          <group group_id="O1">
            <title>High Glycemic Group</title>
            <description>Each subject will receive Bexagliflozin, 20 mg, once daily and open-labeled metformin background medication during the entire study at a stable dose and frequency.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in HbA1c Over Time Among Subjects Who Have Baseline HbA1c of &gt; 10.5% and ≤ 12.0%</title>
          <description>The change from baseline in HbA1c at 6, 12, 18 and 24 weeks was calculated based on the number of subjects with a value at each time point in High Glycemic Group.</description>
          <population>The Number Analyzed only includes the number of subjects with a value at baseline and at the specific visit.</population>
          <units>percentage of HbA1c</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.72" spread="1.027"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.45" spread="1.136"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 18</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.62" spread="1.055"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.82" spread="1.084"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected from Week -1 (run in period: Visit 2) to Week 26 (Follow up: Visit 8).</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Double-blind Group: Bexagliflozin 20 mg</title>
          <description>Each subject will receive bexagliflozin, 20 mg, once daily and open-labeled metformin background medication during the entire study at a stable dose and frequency.</description>
        </group>
        <group group_id="E2">
          <title>Double-blind Group: Placebo</title>
          <description>Each subject will receive placebo (inactive tablet) once daily and open-labeled metformin background medication during the entire study at a stable dose and frequency.</description>
        </group>
        <group group_id="E3">
          <title>High Glycemic Group</title>
          <description>Each subject will receive Bexagliflozin, 20 mg, once daily and open-labeled metformin background medication during the entire study at a stable dose and frequency.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 20.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="158"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="158"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Acute cardiac failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="158"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic ketoacidosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="158"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 20.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="158"/>
                <counts group_id="E2" subjects_affected="28" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="158"/>
                <counts group_id="E2" events="13" subjects_affected="13" subjects_at_risk="159"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Glomerular filtration rate decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetes mellitus inadequate control</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="158"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="159"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Polydipsia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="158"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="159"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Polyuria</sub_title>
                <counts group_id="E1" events="7" subjects_affected="5" subjects_at_risk="158"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="159"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="34"/>
              </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 investigator does not have the right to publish trial results.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Albert Collinson</name_or_title>
      <organization>Theracos Sub, LLC</organization>
      <phone>(508) 630-2129</phone>
      <email>acollinson@theracos.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/NCT03259789
org study id: THR-1442-C-419
nct id: NCT03259789
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to investigate the effect of bexagliflozin compared to placebo
      as an add-on therapy to metformin in lowering hemoglobin A1c (HbA1c) levels in subjects with
      type 2 diabetes mellitus (T2DM).
Approximately 300 subjects with inadequately controlled T2DM on metformin were to be
      recruited from the United States and Japan. Subjects were randomly assigned to receive
      bexagliflozin tablets, 20 mg, or bexagliflozin tablets, placebo, in a ratio of 1:1 once daily
      for 24 weeks. Subjects were to continue taking metformin for the duration of the study. The
      study also enrolled 50 subjects with extremely poorly controlled T2DM on metformin to receive
      open-label bexagliflozin tablets, 20 mg, for 24 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Change From Baseline in HbA1c at Week 24 for Double-blind Group
time frame: Baseline to week 24
description: HbA1c was obtained at baseline and at Week 24. The model-adjusted change from baseline was calculated using mixed-effects repeated measures analysis.
measure: Change From Baseline in HbA1c at Week 24 for High Glycemic Group
time frame: Baseline to week 24
description: The change in HbA1c from baseline at Week 24 in High Glycemic Group was calculated by subtracting the mean HbA1c at baseline from the mean HbA1c at Week 24
measure: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 for Double-blind Group
time frame: Baseline, up to 24 weeks
description: FPG was obtained at baseline and at Week 24. The model-adjusted change from baseline was calculated using mixed-effects repeated measures analysis.
measure: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 for High Glycemic Group
time frame: Baseline, up to 24 weeks
description: The change in FPG from baseline at Week 24 for High Glycemic Group was calculated by subtracting the mean FPG at baseline from the mean FPG at Week 24
measure: Change From Baseline in Systolic Blood Pressure (SBP) at Week 24
time frame: Baseline to week 24
description: Changes from baseline at Week 24 in SBP for the double-blind group and high glycemic group
measure: Proportion of Subjects Achieving HbA1c < 7% Over Time for Double-blind Group
time frame: Baseline, up to 24 weeks
description: The proportion of subjects who achieved HbA1c < 7% at 6, 12, 18 and 24 weeks were calculated based on the number of subjects with a value at each time point for each group. The model-adjusted proportion was calculated based on a logistic analysis using Generalized Estimating Equation (GEE) logistic regression that includes country, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate. An unstructured correlation structure will be used, or autoregressive if the model with the unstructured structure does not converge.
measure: Proportion of Subjects Achieving HbA1c < 7% Over Time for High Glycemic Group
time frame: Baseline, up to 24 weeks
description: The proportion of subjects who achieved HbA1c < 7% at 6, 12, 18 and 24 weeks were calculated based on the number of subjects with a value at each time point for each group.
measure: Change in Body Mass From Baseline to Week 24 in Subjects With a BMI ≥ 25 kg/m2 for Double-blind Group
time frame: Baseline to week 24
description: Changes in body mass from baseline to week 24 was calculated based on LS means for both bexagliflozin and placebo groups.
measure: Change in Body Mass From Baseline to Week 24 in Subjects With a BMI ≥ 25 kg/m2 for High Glycemic Group
time frame: Baseline to week 24
description: The change in body mass from baseline at week 24 for High Glycemic group was calculated by subtracting the mean body mass at baseline from the mean body mass at week 24
measure: Change From Baseline in HbA1c Over Time in Double-blind Treatment Group
time frame: Baseline, up to 24 weeks
description: The change from baseline in HbA1c at 6, 12, 18 and 24 weeks was calculated based on the number of subjects with a value at each time point for each group. The model-adjusted change from baseline was calculated based on a mixed-effects repeated measures analysis that includes country, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.
measure: Change in HbA1c Over Time Among Subjects Who Have Baseline HbA1c of > 10.5% and ≤ 12.0%
time frame: Baseline, up to 24 weeks
description: The change from baseline in HbA1c at 6, 12, 18 and 24 weeks was calculated based on the number of subjects with a value at each time point in High Glycemic Group.
arm group label: Bexagliflozin tablets, 20 mg; Double-Blind
arm group type: Active Comparator
arm group label: Bexagliflozin tablets, Placebo; Double Blind
arm group type: Placebo Comparator
arm group label: Bexagliflozin Tablets, 20 mg; High Glycemic Group
arm group type: Experimental
intervention type: Drug
intervention name: Bexagliflozin tablets, 20 mg
description: Each subject will receive bexagliflozin, 20 mg once daily for the duration of the study.
arm group label: Bexagliflozin tablets, 20 mg; Double-Blind
other name: EGT0001442, EGT0001474
intervention type: Drug
intervention name: Bexagliflozin tablets, placebo
description: Each subject will receive placebo (inactive tablet) once daily for the duration of the study.
arm group label: Bexagliflozin tablets, Placebo; Double Blind
intervention type: Drug
intervention name: Bexagliflozin tablets, 20 mg
description: Each subject will receive bexagliflozin, 20 mg once daily for the duration of the study.
arm group label: Bexagliflozin Tablets, 20 mg; High Glycemic Group
other name: EGT0001442, EGT0001474
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: J, Paul Lock, M.D.
role: Study Director
affiliation: Theracos
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country: Japan
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Bexagliflozin
sharing ipd: No
provided document: 
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certain agreements: 
point of contact: 