<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/NCT04460885</url>
  </required_header>
  <id_info>
    <org_study_id>NN1436-4477</org_study_id>
    <secondary_id>U1111-1247-3878</secondary_id>
    <secondary_id>2020-000442-34</secondary_id>
    <nct_id>NCT04460885</nct_id>
  </id_info>
  <brief_title>A Research Study to Compare Two Types of Insulin, a New Insulin, Insulin Icodec and an Available Insulin, Insulin Glargine, in People With Type 2 Diabetes Who Have Not Used Insulin Before</brief_title>
  <acronym>ONWARDS 1</acronym>
  <official_title>A 78-week Trial Comparing the Effect and Safety of Once Weekly Insulin Icodec and Once Daily Insulin Glargine 100 Units/mL, Both in Combination With Non-insulin Anti-diabetic Treatment, in Insulin naïve Subjects With Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novo Nordisk A/S</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novo Nordisk A/S</source>
  <oversight_info>
    <has_dmc>No</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>
      This study compares insulin icodec (a new insulin taken once a week) to insulin glargine (an&#xD;
      insulin taken once daily which is already available on the market) in people with type 2&#xD;
      diabetes.&#xD;
&#xD;
      The study will look at how well insulin icodec taken weekly controls blood sugar compared to&#xD;
      insulin glargine taken daily. Participants will either get insulin icodec that participants&#xD;
      will have to inject once a week on the same day of the week or insulin glargine that&#xD;
      participants will have to inject once a day at the same time every day. Which treatment&#xD;
      participants get is decided by chance.&#xD;
&#xD;
      The insulin is injected with a needle in a skin fold in the thigh, upper arm or stomach. The&#xD;
      study will last for about 1 ½ years. Participants will have 37 clinic visits and 26 phone&#xD;
      calls with the study doctor. At 11 clinic visits participant will have blood samples taken.&#xD;
      At 8 clinic visits participants cannot eat or drink (except for water) for 8 hours before the&#xD;
      visit.&#xD;
&#xD;
      Participants will be asked to wear a sensor that measures the blood sugar all the time in 5&#xD;
      periods of about one month during the study (about 5 months in total). Women cannot take part&#xD;
      if pregnant, breast-feeding or plan to become pregnant during the study period.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 25, 2020</start_date>
  <completion_date type="Actual">December 1, 2022</completion_date>
  <primary_completion_date type="Actual">May 29, 2022</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in HbA1c</measure>
    <time_frame>From baseline week 0 (V2) to week 52 (V46)</time_frame>
    <description>%-point</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time in target range 3.9-10.0 mmol/L (70-180 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6</measure>
    <time_frame>From week 48 (V42) to week 52 (V46)</time_frame>
    <description>% of readings</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fasting plasma glucose (FPG)</measure>
    <time_frame>From baseline week 0 (V2) to week 52 (V46)</time_frame>
    <description>mmol/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of severe hypoglycaemic episodes (level 3)</measure>
    <time_frame>From baseline week 0 (V2) to week 52 (V46)</time_frame>
    <description>Number of episodes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of clinically significant hypoglycaemic episodes (level 2) (&lt;3.0 mmol/L (54 mg/dL) confirmed by BG meter)</measure>
    <time_frame>From baseline week 0 (V2) to week 52 (V46)</time_frame>
    <description>Number of episodes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of clinically significant hypoglycaemic episodes (level 2) (&lt;3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3)</measure>
    <time_frame>From baseline week 0 (V2) to week 52 (V46)</time_frame>
    <description>Number of episodes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of severe hypoglycaemic episodes (level 3)</measure>
    <time_frame>From baseline week 0 (V2) to week 83 (V63)</time_frame>
    <description>Number of episodes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of clinically significant hypoglycaemic episodes (level 2) (&lt;3.0 mmol/L (54 mg/dL) confirmed by BG meter)</measure>
    <time_frame>From baseline week 0 (V2) to week 83 (V63)</time_frame>
    <description>Number of episodes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of clinically significant hypoglycaemic episodes (level 2) (&lt;3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3)</measure>
    <time_frame>From baseline week 0 (V2) to week 83 (V63)</time_frame>
    <description>Number of episodes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean weekly insulin dose</measure>
    <time_frame>From week 50 (V44) to week 52 (V46)</time_frame>
    <description>U</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in body weight</measure>
    <time_frame>From baseline week 0 (V2) to week 52 (V46)</time_frame>
    <description>kg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time spent &lt; 3.0 mmol/L (54 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6</measure>
    <time_frame>From week 48 (V42) to week 52 (V46)</time_frame>
    <description>% of readings</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time spent &gt; 10 mmol/L (180 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6</measure>
    <time_frame>From week 48 (V42) to week 52 (V46)</time_frame>
    <description>% of readings</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">984</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Insulin icodec</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Insulin icodec + non-insulin anti-diabetic drugs. The pre-trial non-insulin anti-diabetic background medication should be maintained at the stable, pre-trial dose and at the same frequency during the entire treatment period</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Insulin glargine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Insulin glargine + non-insulin anti-diabetic drugs. The pre-trial non-insulin anti-diabetic background medication should be maintained at the stable, pre-trial dose and at the same frequency during the entire treatment period</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Insulin icodec</intervention_name>
    <description>Participants will receive subcutaneous (s.c.) injections of insulin icodec once weekly for 78 weeks.</description>
    <arm_group_label>Insulin icodec</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Insulin glargine</intervention_name>
    <description>Participants will receive subcutaneous (s.c.) injections of insulin glargine once daily for 78 weeks</description>
    <arm_group_label>Insulin glargine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female aged above or equal to 18 years at the time of signing informed&#xD;
             consent.&#xD;
&#xD;
          -  Diagnosed with type 2 diabetes mellitus (T2D) 180 days or more prior to the day of&#xD;
             screening.&#xD;
&#xD;
          -  HbA1c from 7.0-11.0% (53.0-96.7 mmol/mol) both inclusive at screening confirmed by&#xD;
             central laboratory analysis.&#xD;
&#xD;
          -  Insulin naïve. However, short term insulin treatment for a maximum of 14 days prior to&#xD;
             the day of screening is allowed, as is prior insulin treatment for gestational&#xD;
             diabetes.&#xD;
&#xD;
          -  Stable daily dose(s) 90 days or more prior to the day of screening of any of the&#xD;
             following anti-diabetic drug(s) or combination regimen(s): a. Any metformin&#xD;
             formulations at least or greater than 1500 mg or maximum tolerated or effective dose.&#xD;
             b. Any metformin combination formulations equal to or above 1500 mg or maximum&#xD;
             tolerated or effective dose. c. Any of the following oral anti-diabetic drug classes&#xD;
             including combinations ((equal to or above half of the maximum approved dose according&#xD;
             to local label or maximum tolerated or effective dose): Sulfonylureas, Meglitinides&#xD;
             (glinides), dipeptidyl peptidase-4 (DPP-4) inhibitors, Sodium-glucose co-transporter-2&#xD;
             (SGLT2) inhibitors, Thiazolidinediones, Alpha-glucosidase inhibitors, Oral combination&#xD;
             products (for the allowed individual oral anti-diabetic drugs), Oral or injectable&#xD;
             glucagon-like peptide 1 (GLP-1) receptor agonists&#xD;
&#xD;
          -  Body mass index (BMI) equal to or below 40.0 kg/m^2.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any episodes (as declared by the subject or in the medical records) of diabetic&#xD;
             ketoacidosis within 90 days prior to the day of screening.&#xD;
&#xD;
          -  Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or&#xD;
             transient ischaemic attack within 180 days prior to the day of screening.&#xD;
&#xD;
          -  Chronic heart failure classified as being in New York Heart Association Class IV at&#xD;
             screening.&#xD;
&#xD;
          -  Anticipated initiation or change in concomitant medications (for more than 14&#xD;
             consecutive days) known to affect weight or glucose metabolism (e.g. treatment with&#xD;
             orlistat, thyroid hormones, or corticosteroids).&#xD;
&#xD;
          -  Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by&#xD;
             a fundus examination performed within the past 90 days prior to screening or in the&#xD;
             period between screening and randomisation. Pharmacological pupil-dilation is a&#xD;
             requirement unless using a digital fundus photography camera specified for non-dilated&#xD;
             examination&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Transparency (1452)</last_name>
    <role>Study Director</role>
    <affiliation>Novo Nordisk A/S</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Guntersville</city>
        <state>Alabama</state>
        <zip>35976</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Buena Park</city>
        <state>California</state>
        <zip>90620</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Lancaster</city>
        <state>California</state>
        <zip>93534</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Palm Springs</city>
        <state>California</state>
        <zip>92262</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Ventura</city>
        <state>California</state>
        <zip>93003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Waterbury</city>
        <state>Connecticut</state>
        <zip>06708</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>New Port Richey</city>
        <state>Florida</state>
        <zip>34652</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32825</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Palm Harbor</city>
        <state>Florida</state>
        <zip>34684-3609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96814</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Gurnee</city>
        <state>Illinois</state>
        <zip>60031</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>West Des Moines</city>
        <state>Iowa</state>
        <zip>50265</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Topeka</city>
        <state>Kansas</state>
        <zip>66606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Paducah</city>
        <state>Kentucky</state>
        <zip>42001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Hyattsville</city>
        <state>Maryland</state>
        <zip>20782</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Rockville</city>
        <state>Maryland</state>
        <zip>20852</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Troy</city>
        <state>Michigan</state>
        <zip>48098</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68198-3020</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>West Seneca</city>
        <state>New York</state>
        <zip>14224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Greenville</city>
        <state>North Carolina</state>
        <zip>27834</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Wilmington</city>
        <state>North Carolina</state>
        <zip>28401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Fargo</city>
        <state>North Dakota</state>
        <zip>58104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Canton</city>
        <state>Ohio</state>
        <zip>44718</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45439</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Franklin</city>
        <state>Ohio</state>
        <zip>45005</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Norman</city>
        <state>Oklahoma</state>
        <zip>73069</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Murrells Inlet</city>
        <state>South Carolina</state>
        <zip>29576</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Simpsonville</city>
        <state>South Carolina</state>
        <zip>29681-1538</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kingsport</city>
        <state>Tennessee</state>
        <zip>37660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78731</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390-9302</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77074</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Lampasas</city>
        <state>Texas</state>
        <zip>76550</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Live Oak</city>
        <state>Texas</state>
        <zip>78233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Round Rock</city>
        <state>Texas</state>
        <zip>78681</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Sugar Land</city>
        <state>Texas</state>
        <zip>77478</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Saint George</city>
        <state>Utah</state>
        <zip>84790</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Newport News</city>
        <state>Virginia</state>
        <zip>23606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Renton</city>
        <state>Washington</state>
        <zip>98057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Osijek</city>
        <state>Osječko - Baranjska Županija</state>
        <zip>31000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Karlovac</city>
        <zip>47000</zip>
        <country>Croatia</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Rijeka</city>
        <zip>51000</zip>
        <country>Croatia</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Varazdin</city>
        <zip>42 000</zip>
        <country>Croatia</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Hyderabad</city>
        <state>Andhra Pradesh</state>
        <zip>500072</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Rohtak</city>
        <state>Haryana</state>
        <zip>124001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Indore</city>
        <state>Madhya Pradesh</state>
        <zip>452010</zip>
        <country>India</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Mumbai</city>
        <state>Maharashtra</state>
        <zip>400008</zip>
        <country>India</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Pune</city>
        <state>Maharashtra</state>
        <zip>411021</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Chennai</city>
        <state>Tamil Nadu</state>
        <zip>600086</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Vellore</city>
        <state>Tamil Nadu</state>
        <zip>632004</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Hyderabad</city>
        <state>Telengana</state>
        <zip>500003</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Hyderbad</city>
        <state>Telengana</state>
        <zip>500 012</zip>
        <country>India</country>
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    </facility>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Holon</city>
        <zip>58100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Jerusalem</city>
        <zip>91120</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kfar Saba</city>
        <zip>44281</zip>
        <country>Israel</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Petach Tikva</city>
        <zip>49100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Rehovot</city>
        <zip>76100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Roma</city>
        <state>RM</state>
        <zip>00161</zip>
        <country>Italy</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Bergamo</city>
        <zip>24127</zip>
        <country>Italy</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Catanzaro</city>
        <zip>88100</zip>
        <country>Italy</country>
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  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Milano</city>
        <zip>20122</zip>
        <country>Italy</country>
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  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Palermo</city>
        <zip>90127</zip>
        <country>Italy</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Chigasaki-shi, Kanagawa</city>
        <state>Kanagawa, Japan</state>
        <zip>253-0044</zip>
        <country>Japan</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Miyazaki-shi</city>
        <state>Miyazaki, Japan</state>
        <zip>880-0034</zip>
        <country>Japan</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Bunkyo-ku, Tokyo</city>
        <zip>113-8655</zip>
        <country>Japan</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Chiba</city>
        <zip>261-0004</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Fukuoka-shi, Fukuoka</city>
        <zip>819-0006</zip>
        <country>Japan</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Ibaraki</city>
        <zip>311-0113</zip>
        <country>Japan</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kitakyusyu-shi, Fukuoka</city>
        <zip>800-0222</zip>
        <country>Japan</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Minato-ku, Tokyo</city>
        <zip>105-8470</zip>
        <country>Japan</country>
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    </facility>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Miyagi</city>
        <zip>983-0039</zip>
        <country>Japan</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Osaka</city>
        <zip>569-1045</zip>
        <country>Japan</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Saitama</city>
        <zip>336-0967</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Shimotsuke-shi, Tochigi</city>
        <zip>329-0433</zip>
        <country>Japan</country>
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    </facility>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tochigi</city>
        <zip>323-0022</zip>
        <country>Japan</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Ushiku-shi, Ibaraki</city>
        <zip>300-1207</zip>
        <country>Japan</country>
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    </facility>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Guadalajara</city>
        <state>Jalisco</state>
        <zip>44600</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Mexico City</city>
        <state>México, D.F.</state>
        <zip>06700</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Monterrey</city>
        <state>Nuevo León</state>
        <zip>64460</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Hermosillo</city>
        <state>Sonora</state>
        <zip>83280</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Lublin</city>
        <state>Lubelskie</state>
        <zip>20-044</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Lublin</city>
        <state>Lubelski</state>
        <zip>20-538</zip>
        <country>Poland</country>
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    </facility>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Warsaw</city>
        <state>Mazowieckie</state>
        <zip>00-710</zip>
        <country>Poland</country>
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    </facility>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Bialystok</city>
        <state>Podlaskie</state>
        <zip>15-435</zip>
        <country>Poland</country>
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    </facility>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Gorzow Wielkopolski</city>
        <zip>66-400</zip>
        <country>Poland</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Radom</city>
        <zip>26-600</zip>
        <country>Poland</country>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Wierzchoslawice</city>
        <zip>33-122</zip>
        <country>Poland</country>
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    </facility>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Zabrze</city>
        <zip>41-800</zip>
        <country>Poland</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Bayamon</city>
        <zip>00961</zip>
        <country>Puerto Rico</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Manati</city>
        <zip>00674</zip>
        <country>Puerto Rico</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kemerovo</city>
        <zip>650066</zip>
        <country>Russian Federation</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Moscow</city>
        <zip>117292</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Moscow</city>
        <zip>119435</zip>
        <country>Russian Federation</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Novosibirsk</city>
        <zip>630099</zip>
        <country>Russian Federation</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Novosibirsk</city>
        <zip>630117</zip>
        <country>Russian Federation</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Penza</city>
        <zip>440052</zip>
        <country>Russian Federation</country>
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  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>194291</zip>
        <country>Russian Federation</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>194156</zip>
        <country>Russian Federation</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>194356</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>197110</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Saratov</city>
        <zip>410039</zip>
        <country>Russian Federation</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tomsk</city>
        <zip>634050</zip>
        <country>Russian Federation</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Voronezh</city>
        <zip>394018</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Yoshkar-Ola</city>
        <zip>424004</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Sahy</city>
        <state>Slovak Republic</state>
        <zip>93601</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Bratislava</city>
        <zip>84102</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Bratislava</city>
        <zip>851 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Malacky</city>
        <zip>901 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Moldava nad Bodvou</city>
        <zip>045 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Trebisov</city>
        <zip>07501</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>La Coruña</city>
        <zip>15006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>La Roca del Vallés</city>
        <zip>08430</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Madrid</city>
        <zip>28006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Madrid</city>
        <zip>28020</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Pozuelo de Alarcon</city>
        <zip>28223</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Blackpool</city>
        <zip>FY3 7EN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Bollington</city>
        <zip>SK10 5JH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Bradford-on-Avon</city>
        <zip>BA15 1DQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Bristol</city>
        <zip>BS10 5NB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Cambridge</city>
        <zip>CB2 0QQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Dorset</city>
        <zip>BH16 5PW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Edinburgh</city>
        <zip>EH4 2XU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Hinckley</city>
        <zip>LE10 2SE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Soham</city>
        <zip>CB7 5JD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Swansea</city>
        <zip>SA2 8PP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Truro</city>
        <zip>TR1 3LJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Wellingborough</city>
        <zip>NN8 4RW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Croatia</country>
    <country>India</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Mexico</country>
    <country>Poland</country>
    <country>Puerto Rico</country>
    <country>Russian Federation</country>
    <country>Slovakia</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Philis-Tsimikas A, Bajaj HS, Begtrup K, Cailleteau R, Gowda A, Lingvay I, Mathieu C, Russell-Jones D, Rosenstock J. Rationale and design of the phase 3a development programme (ONWARDS 1-6 trials) investigating once-weekly insulin icodec in diabetes. Diabetes Obes Metab. 2023 Feb;25(2):331-341. doi: 10.1111/dom.14871. Epub 2022 Oct 14.</citation>
    <PMID>36106652</PMID>
  </results_reference>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <disposition_first_submitted>May 27, 2023</disposition_first_submitted>
  <disposition_first_submitted_qc>May 27, 2023</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">May 31, 2023</disposition_first_posted>
  <last_update_submitted>July 3, 2023</last_update_submitted>
  <last_update_submitted_qc>July 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 6, 2023</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>Insulin</mesh_term>
    <mesh_term>Insulin, Globin Zinc</mesh_term>
    <mesh_term>Insulin Glargine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>According to the Novo Nordisk disclosure commitment on novonordisk-trials.com</ipd_description>
    <ipd_url>http://novonordisk-trials.com</ipd_url>
  </patient_data>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT04460885
org study id: NN1436-4477
secondary id: U1111-1247-3878
secondary id: 2020-000442-34
nct id: NCT04460885
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This study compares insulin icodec (a new insulin taken once a week) to insulin glargine (an
      insulin taken once daily which is already available on the market) in people with type 2
      diabetes.

      The study will look at how well insulin icodec taken weekly controls blood sugar compared to
      insulin glargine taken daily. Participants will either get insulin icodec that participants
      will have to inject once a week on the same day of the week or insulin glargine that
      participants will have to inject once a day at the same time every day. Which treatment
      participants get is decided by chance.

      The insulin is injected with a needle in a skin fold in the thigh, upper arm or stomach. The
      study will last for about 1 ½ years. Participants will have 37 clinic visits and 26 phone
      calls with the study doctor. At 11 clinic visits participant will have blood samples taken.
      At 8 clinic visits participants cannot eat or drink (except for water) for 8 hours before the
      visit.

      Participants will be asked to wear a sensor that measures the blood sugar all the time in 5
      periods of about one month during the study (about 5 months in total). Women cannot take part
      if pregnant, breast-feeding or plan to become pregnant during the study period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in HbA1c
time frame: From baseline week 0 (V2) to week 52 (V46)
description: %-point
measure: Time in target range 3.9-10.0 mmol/L (70-180 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6
time frame: From week 48 (V42) to week 52 (V46)
description: % of readings
measure: Change in fasting plasma glucose (FPG)
time frame: From baseline week 0 (V2) to week 52 (V46)
description: mmol/L
measure: Number of severe hypoglycaemic episodes (level 3)
time frame: From baseline week 0 (V2) to week 52 (V46)
description: Number of episodes
measure: Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL) confirmed by BG meter)
time frame: From baseline week 0 (V2) to week 52 (V46)
description: Number of episodes
measure: Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3)
time frame: From baseline week 0 (V2) to week 52 (V46)
description: Number of episodes
measure: Number of severe hypoglycaemic episodes (level 3)
time frame: From baseline week 0 (V2) to week 83 (V63)
description: Number of episodes
measure: Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL) confirmed by BG meter)
time frame: From baseline week 0 (V2) to week 83 (V63)
description: Number of episodes
measure: Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3)
time frame: From baseline week 0 (V2) to week 83 (V63)
description: Number of episodes
measure: Mean weekly insulin dose
time frame: From week 50 (V44) to week 52 (V46)
description: U
measure: Change in body weight
time frame: From baseline week 0 (V2) to week 52 (V46)
description: kg
measure: Time spent < 3.0 mmol/L (54 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6
time frame: From week 48 (V42) to week 52 (V46)
description: % of readings
measure: Time spent > 10 mmol/L (180 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6
time frame: From week 48 (V42) to week 52 (V46)
description: % of readings
arm group label: Insulin icodec
arm group type: Experimental
description: Insulin icodec + non-insulin anti-diabetic drugs. The pre-trial non-insulin anti-diabetic background medication should be maintained at the stable, pre-trial dose and at the same frequency during the entire treatment period
arm group label: Insulin glargine
arm group type: Active Comparator
description: Insulin glargine + non-insulin anti-diabetic drugs. The pre-trial non-insulin anti-diabetic background medication should be maintained at the stable, pre-trial dose and at the same frequency during the entire treatment period
intervention type: Drug
intervention name: Insulin icodec
description: Participants will receive subcutaneous (s.c.) injections of insulin icodec once weekly for 78 weeks.
arm group label: Insulin icodec
intervention type: Drug
intervention name: Insulin glargine
description: Participants will receive subcutaneous (s.c.) injections of insulin glargine once daily for 78 weeks
arm group label: Insulin glargine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Transparency (1452)
role: Study Director
affiliation: Novo Nordisk A/S
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country: Croatia
country: India
country: Israel
country: Italy
country: Japan
country: Mexico
country: Poland
country: Puerto Rico
country: Russian Federation
country: Slovakia
country: Spain
country: United Kingdom
country: United States
citation: Philis-Tsimikas A, Bajaj HS, Begtrup K, Cailleteau R, Gowda A, Lingvay I, Mathieu C, Russell-Jones D, Rosenstock J. Rationale and design of the phase 3a development programme (ONWARDS 1-6 trials) investigating once-weekly insulin icodec in diabetes. Diabetes Obes Metab. 2023 Feb;25(2):331-341. doi: 10.1111/dom.14871. Epub 2022 Oct 14.
PMID: 36106652
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Insulin
mesh term: Insulin, Globin Zinc
mesh term: Insulin Glargine
sharing ipd: Yes
ipd description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
ipd url: http://novonordisk-trials.com