<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/NCT02230618</url>
  </required_header>
  <id_info>
    <org_study_id>NN5401-4149</org_study_id>
    <secondary_id>U1111-1157-0615</secondary_id>
    <secondary_id>ENCEPP/SDPP/6587</secondary_id>
    <nct_id>NCT02230618</nct_id>
  </id_info>
  <brief_title>Post Marketing Surveillance (PMS) Study of Ryzodeg™ (Insulin Degludec/Insulin Aspart) in Patients With Diabetes Mellitus in Routine Clinical Practice in India</brief_title>
  <official_title>A Multi-centre, Prospective, Open-label, Single-arm, Non-interventional, Post Marketing Surveillance (PMS) Study of Ryzodeg™ (Insulin Degludec/Insulin Aspart) to Evaluate Long Term Safety and Efficacy in Patients With Diabetes Mellitus in Routine Clinical Practice in India</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is conducted in Asia. The aim of this study is to evaluate long term safety and&#xD;
      efficacy in patients with diabetes mellitus in routine clinical practice in India.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 24, 2015</start_date>
  <completion_date type="Actual">June 1, 2017</completion_date>
  <primary_completion_date type="Actual">June 1, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of Adverse Events (AEs)</measure>
    <time_frame>Weeks 0-52</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serious Adverse Events (SAEs)</measure>
    <time_frame>Weeks 0-52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serious Adverse Drug Reactions (SADRs)</measure>
    <time_frame>Weeks 0-52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Drug Reactions (ADRs)</measure>
    <time_frame>Weeks 0-52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severe or Blood glucose (BG) Confirmed hypoglycaemia</measure>
    <time_frame>Weeks 0-52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in HbA1c (glycosylated haemoglobin)</measure>
    <time_frame>Week 0, week 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fasting Plasma Glucose (FPG)</measure>
    <time_frame>Week 0, week 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Post Prandial Blood/Plasma Glucose (PPBG/PPPG)</measure>
    <time_frame>Week 0, week 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The reason for initiating or intensifying treatment with Ryzodeg™</measure>
    <time_frame>Week 0 - week 52</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1029</enrollment>
  <condition>Diabetes</condition>
  <condition>Diabetes Mellitus, Type 1</condition>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Ryzodeg™</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>insulin degludec/insulin aspart</intervention_name>
    <description>Ryzodeg™ will be prescribed by the physician under normal clinical practice conditions and will be obtained/purchased from the chemist based on physician prescription. No treatment given.</description>
    <arm_group_label>Ryzodeg™</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with diabetes where the treating physician has decided to start Ryzodeg™ according&#xD;
        to routine clinical practice will qualify for starting treatment with Ryzodeg™.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed consent obtained before any study-related activities. (Study-related&#xD;
             activities are any procedures that are related to recording of data according to the&#xD;
             protocol). The historical data including the data before informed consent obtained&#xD;
             (e.g., HbA1c (Glycated Haemoglobin ), FPG (Fasting Plasma Glucose), PPPG (Postprandial&#xD;
             Plasma Glucose), severe hypoglycaemia before the start of Ryzodeg™ therapy) can be&#xD;
             used for baseline data&#xD;
&#xD;
          -  Patients with insulin requiring diabetes mellitus and who are scheduled to start&#xD;
             treatment with Ryzodeg™ based on the clinical judgment of their treating physician&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known or suspected allergy to Ryzodeg™ any of the active substances or any of the&#xD;
             excipients&#xD;
&#xD;
          -  Previous participation in this study&#xD;
&#xD;
          -  Mental incapacity, unwillingness or language barriers precluding adequate&#xD;
             understanding or cooperation&#xD;
&#xD;
          -  Patients who are or have previously been on Ryzodeg™ therapy&#xD;
&#xD;
          -  Patients who are participating in other studies or clinical trials&#xD;
&#xD;
          -  Patients who are pregnant, breast feeding or have the intention of becoming pregnant&#xD;
             within the following 12 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Global Clinical Registry (GCR, 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>Guntur</city>
        <state>Andhra Pradesh</state>
        <zip>522001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Vijayawada</city>
        <state>Andhra Pradesh</state>
        <zip>520002</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Visakhapatnam</city>
        <state>Andhra Pradesh</state>
        <zip>530002</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Ahmedabad</city>
        <state>Gujarat</state>
        <zip>380007</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Ahmedabad</city>
        <state>Gujarat</state>
        <zip>380052</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Ahmedabad</city>
        <state>Gujarat</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Gandhinagar</city>
        <state>Gujarat</state>
        <zip>382428</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Ghuma</city>
        <state>Gujarat</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Surat</city>
        <state>Gujarat</state>
        <zip>395002</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Bangalore</city>
        <state>Karnataka</state>
        <zip>560092</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Bangalore</city>
        <state>Karnataka</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Mangalore</city>
        <state>Karnataka</state>
        <zip>575001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Angamaly</city>
        <state>Kerala</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kochi</city>
        <state>Kerala</state>
        <zip>682041</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Thrissur</city>
        <state>Kerala</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Trivandrum</city>
        <state>Kerala</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Indore</city>
        <state>Madhya Pradesh</state>
        <zip>452008</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Indore</city>
        <state>Madhya Pradesh</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Mumbai</city>
        <state>Maharashtra</state>
        <zip>400053</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Pune</city>
        <state>Maharashtra</state>
        <zip>411001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Amritsar</city>
        <state>Punjab</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Chandigarh</city>
        <state>Punjab</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Jaipur</city>
        <state>Rajasthan</state>
        <zip>302017</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Jaipur</city>
        <state>Rajasthan</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Chennai</city>
        <state>Tamil Nadu</state>
        <zip>600037</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Chennai</city>
        <state>Tamil Nadu</state>
        <zip>600100</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Chennai</city>
        <state>Tamil Nadu</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Coimbatore</city>
        <state>Tamil Nadu</state>
        <zip>641009</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Madurai</city>
        <state>Tamil Nadu</state>
        <zip>625 020</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Lucknow</city>
        <state>Uttar Pradesh</state>
        <zip>226005</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Lucknow</city>
        <state>Uttar Pradesh</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Noida</city>
        <state>Uttar Pradesh</state>
        <zip>201301</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kolkata</city>
        <state>West Bengal</state>
        <zip>700054</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Bilaspur</city>
        <zip>495001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Thriruvananthapuram</city>
        <zip>695 032</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <link>
    <url>http://novonordisk-trials.com</url>
    <description>Clinical Trials at Novo Nordisk</description>
  </link>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>August 29, 2014</study_first_submitted>
  <study_first_submitted_qc>August 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <last_update_submitted>March 12, 2018</last_update_submitted>
  <last_update_submitted_qc>March 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2018</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>
    <mesh_term>Diabetes Mellitus, Type 1</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 Aspart</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02230618
org study id: NN5401-4149
secondary id: U1111-1157-0615
secondary id: ENCEPP/SDPP/6587
nct id: NCT02230618
lead sponsor: 
has dmc: No
This study is conducted in Asia. The aim of this study is to evaluate long term safety and
      efficacy in patients with diabetes mellitus in routine clinical practice in India.
observational model: Cohort
time perspective: Prospective
measure: Incidence of Adverse Events (AEs)
time frame: Weeks 0-52
measure: Serious Adverse Events (SAEs)
time frame: Weeks 0-52
measure: Serious Adverse Drug Reactions (SADRs)
time frame: Weeks 0-52
measure: Adverse Drug Reactions (ADRs)
time frame: Weeks 0-52
measure: Severe or Blood glucose (BG) Confirmed hypoglycaemia
time frame: Weeks 0-52
measure: Change in HbA1c (glycosylated haemoglobin)
time frame: Week 0, week 52
measure: Change in Fasting Plasma Glucose (FPG)
time frame: Week 0, week 52
measure: Change in Post Prandial Blood/Plasma Glucose (PPBG/PPPG)
time frame: Week 0, week 52
measure: The reason for initiating or intensifying treatment with Ryzodeg™
time frame: Week 0 - week 52
arm group label: Ryzodeg™
intervention type: Drug
intervention name: insulin degludec/insulin aspart
description: Ryzodeg™ will be prescribed by the physician under normal clinical practice conditions and will be obtained/purchased from the chemist based on physician prescription. No treatment given.
arm group label: Ryzodeg™
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Global Clinical Registry (GCR, 1452)
role: Study Director
affiliation: Novo Nordisk A/S
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country: India
url: http://novonordisk-trials.com
description: Clinical Trials at Novo Nordisk
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Diabetes Mellitus, Type 1
mesh term: Insulin
mesh term: Insulin Aspart