<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/NCT03797885</url>
  </required_header>
  <id_info>
    <org_study_id>NN2211-4435</org_study_id>
    <secondary_id>U1111-1207-2878</secondary_id>
    <nct_id>NCT03797885</nct_id>
  </id_info>
  <brief_title>A Study of People With Type 2 Diabetes Who Have Diseases That Affect the Heart and Blood Vessels. The Study Will Also Look at the Treatment of a Group of These People in Hospitals in Portugal</brief_title>
  <acronym>PICT2RE</acronym>
  <official_title>An Observational Cross-sectional Study to Estimate the Prevalence of Cardiovascular Disease and CV Risk Factors in T2DM Patients Including a Retrospective Phase to Evaluate the Clinical Management of a Subgroup of Patients in the Hospital Setting in Portugal</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_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to estimate the number of patients with cardiovascular disease and risk&#xD;
      factors in patients who had been diagnosed with type 2 diabetes mellitus. Simultaneously,&#xD;
      this study also intends to obtain more information about the management of type 2 diabetes&#xD;
      mellitus patients with established cardiovascular disease. This study is non-interventional,&#xD;
      which means that will not require participant's further related visits or procedures. The&#xD;
      study will collect the participant's clinical data from the current visit and, when&#xD;
      applicable, within the last 3 years.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2019</start_date>
  <completion_date type="Actual">October 15, 2019</completion_date>
  <primary_completion_date type="Actual">October 15, 2019</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of type 2 diabetes mellitus (T2DM) patients with cardiovascular risk factors (CVRFs) and/or established cardiovascular disease (CVD), regardless the date of diagnosis</measure>
    <time_frame>Baseline (month 0)</time_frame>
    <description>Proportion of subjects.&#xD;
CVRFs are defined as a history of one or more of the following criteria:&#xD;
Overweight or obese&#xD;
Family history of CVD (1st degree)&#xD;
Hypertension&#xD;
Hypercholesterolemia&#xD;
Low high-density lipoproteins&#xD;
Hypertriglyceridemia&#xD;
Smoking habits&#xD;
Sedentary lifestyle -as per Investigator discretion according to his/her normal practice.&#xD;
CVD is defined as a history of one or more of the following events:&#xD;
Stroke&#xD;
Transient ischaemic attack&#xD;
Ischaemic heart disease including myocardial infarction&#xD;
Congestive heart failure&#xD;
Atrial fibrillation&#xD;
Aortic aneurism&#xD;
Peripheral or carotid artery disease</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hypoglycaemic episodes</measure>
    <time_frame>During 3 years before baseline (0 to -36 months)</time_frame>
    <description>Number of episodes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hyperglycaemic episodes</measure>
    <time_frame>During 3 years before baseline (0 to -36 months)</time_frame>
    <description>Number of episodes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of T2DM complications (yes/no)</measure>
    <time_frame>During 3 years before baseline (0 to -36 months)</time_frame>
    <description>Number of patients for whom 'presence of T2DM complications' has been answered yes/no respectively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Types of T2DM complications</measure>
    <time_frame>During 3 years before baseline (0 to -36 months)</time_frame>
    <description>Types of T2DM complications: Retinopathy, Diabetic neuropathy (peripheral, autonomic), Diabetic nephropathy, Amputation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital appointments</measure>
    <time_frame>During 3 years before baseline (0 to -36 months)</time_frame>
    <description>Number of cardiology, ophthalmology, nephrology, and vascular surgery appointments</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalisation episodes</measure>
    <time_frame>During 3 years before baseline (0 to -36 months)</time_frame>
    <description>Number of episodes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emergency visits</measure>
    <time_frame>During 3 years before baseline (0 to -36 months)</time_frame>
    <description>Number of visits</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in waist circumference</measure>
    <time_frame>During 3 years before baseline (0 to -36 months)</time_frame>
    <description>Measured in cm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in body mass index</measure>
    <time_frame>During 3 years before baseline (0 to -36 months)</time_frame>
    <description>Measured in kg/m^2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in blood pressure</measure>
    <time_frame>During 3 years before baseline (0 to -36 months)</time_frame>
    <description>Measured in mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in urine albumin</measure>
    <time_frame>During 3 years before baseline (0 to -36 months)</time_frame>
    <description>Measured in mg/24 hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in urine albumin</measure>
    <time_frame>During 3 years before baseline (0 to -36 months)</time_frame>
    <description>Measured in microgram/minute</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in glycosylated hemoglobin (HbA1c)</measure>
    <time_frame>During 3 years before baseline (0 to -36 months)</time_frame>
    <description>Measured in mmol/mol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in HbA1c</measure>
    <time_frame>During 3 years before baseline (0 to -36 months)</time_frame>
    <description>Measured in %</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Estimated Glomerular Filtration Rate (eGFR)</measure>
    <time_frame>During 3 years before baseline (0 to -36 months)</time_frame>
    <description>Measured in mL/min/1.73 m^2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in total cholesterol</measure>
    <time_frame>During 3 years before baseline (0 to -36 months)</time_frame>
    <description>measured in mg/dl</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in low-density lipoprotein cholesterol</measure>
    <time_frame>During 3 years before baseline (0 to -36 months)</time_frame>
    <description>measured in mg/dl</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in high-density lipoprotein cholesterol</measure>
    <time_frame>During 3 years before baseline (0 to -36 months)</time_frame>
    <description>measured in mg/dl</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in triglyceride</measure>
    <time_frame>During 3 years before baseline (0 to -36 months)</time_frame>
    <description>measured in mg/dl</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Type of pharmacological treatment</measure>
    <time_frame>During 3 years before baseline (0 to -36 months)</time_frame>
    <description>Types of pharmacological treatment: Antidiabetics Antihypertensive Lipid lowering therapy Antiplatelet/anticoagulant therapy</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">730</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Patients with type 2 diabetes mellitus (T2DM)</arm_group_label>
    <description>Patients with type 2 diabetes, at the hospital setting.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients with T2DM and established cardiovascular disease</arm_group_label>
    <description>Subgroup of patients with type 2 diabetes and established cardiovascular disease</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No treatment given</intervention_name>
    <description>No treatment is administered to the participants for this study</description>
    <arm_group_label>Patients with T2DM and established cardiovascular disease</arm_group_label>
    <arm_group_label>Patients with type 2 diabetes mellitus (T2DM)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with type 2 diabetes mellitus&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Main study population (Data collection - Prevalence):&#xD;
&#xD;
          -  Signed Informed Consent Form (ICF) obtained before any study-related activities&#xD;
             (study-related activities are any procedures related to recording of data according to&#xD;
             protocol)&#xD;
&#xD;
          -  Male or female patient, age greater or equal to 18 years at the time of signing ICF&#xD;
&#xD;
          -  Patients diagnosed with type 2 diabetes&#xD;
&#xD;
        Subgroup (Data collection - Patient management):&#xD;
&#xD;
          -  Patients followed at the hospital setting by the endocrinologist or internal medicine&#xD;
             specialist (ambulatory diabetes management) and with available medical records,&#xD;
             retrospectively within the last three years&#xD;
&#xD;
          -  Patients with type 2 diabetes mellitus and established cardiovascular disease&#xD;
             diagnosed at least three years ago&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous participation in this study. Participation is defined as signed ICF&#xD;
&#xD;
          -  Female patient who is pregnant or breast-feeding&#xD;
&#xD;
          -  Patients with type 1 diabetes&#xD;
&#xD;
          -  Participation in a clinical trial within the last 3 years&#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 Reporting Anchor and Disclosure (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>Almada</city>
        <zip>2805-267</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Caldas da Rainha</city>
        <zip>2500-176</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Leiria</city>
        <zip>2410-197</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Lisboa</city>
        <zip>1349-019</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Lisboa</city>
        <zip>1500-650</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Lisboa</city>
        <zip>1600-777</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Matosinhos</city>
        <zip>4464-513</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Portimão</city>
        <zip>8500-338</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Porto</city>
        <zip>4099-001</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Porto</city>
        <zip>4200-319</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Viana do Castelo</city>
        <zip>4901-858</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Vila Nova de Gaia</city>
        <zip>4434-502</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Vila Real</city>
        <zip>5000-508</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Viseu</city>
        <zip>3504-509</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Portugal</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>November 19, 2020</last_update_submitted>
  <last_update_submitted_qc>November 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 20, 2020</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, Type 2</mesh_term>
  </condition_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 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/NCT03797885
org study id: NN2211-4435
secondary id: U1111-1207-2878
nct id: NCT03797885
lead sponsor: 
has dmc: No
is fda regulated device: No
This study aims to estimate the number of patients with cardiovascular disease and risk
      factors in patients who had been diagnosed with type 2 diabetes mellitus. Simultaneously,
      this study also intends to obtain more information about the management of type 2 diabetes
      mellitus patients with established cardiovascular disease. This study is non-interventional,
      which means that will not require participant's further related visits or procedures. The
      study will collect the participant's clinical data from the current visit and, when
      applicable, within the last 3 years.
observational model: Cohort
time perspective: Cross-Sectional
measure: Proportion of type 2 diabetes mellitus (T2DM) patients with cardiovascular risk factors (CVRFs) and/or established cardiovascular disease (CVD), regardless the date of diagnosis
time frame: Baseline (month 0)
description: Proportion of subjects.
CVRFs are defined as a history of one or more of the following criteria:
Overweight or obese
Family history of CVD (1st degree)
Hypertension
Hypercholesterolemia
Low high-density lipoproteins
Hypertriglyceridemia
Smoking habits
Sedentary lifestyle -as per Investigator discretion according to his/her normal practice.
CVD is defined as a history of one or more of the following events:
Stroke
Transient ischaemic attack
Ischaemic heart disease including myocardial infarction
Congestive heart failure
Atrial fibrillation
Aortic aneurism
Peripheral or carotid artery disease
measure: Hypoglycaemic episodes
time frame: During 3 years before baseline (0 to -36 months)
description: Number of episodes
measure: Hyperglycaemic episodes
time frame: During 3 years before baseline (0 to -36 months)
description: Number of episodes
measure: Presence of T2DM complications (yes/no)
time frame: During 3 years before baseline (0 to -36 months)
description: Number of patients for whom 'presence of T2DM complications' has been answered yes/no respectively
measure: Types of T2DM complications
time frame: During 3 years before baseline (0 to -36 months)
description: Types of T2DM complications: Retinopathy, Diabetic neuropathy (peripheral, autonomic), Diabetic nephropathy, Amputation.
measure: Hospital appointments
time frame: During 3 years before baseline (0 to -36 months)
description: Number of cardiology, ophthalmology, nephrology, and vascular surgery appointments
measure: Hospitalisation episodes
time frame: During 3 years before baseline (0 to -36 months)
description: Number of episodes
measure: Emergency visits
time frame: During 3 years before baseline (0 to -36 months)
description: Number of visits
measure: Change in waist circumference
time frame: During 3 years before baseline (0 to -36 months)
description: Measured in cm
measure: Change in body mass index
time frame: During 3 years before baseline (0 to -36 months)
description: Measured in kg/m^2
measure: Change in blood pressure
time frame: During 3 years before baseline (0 to -36 months)
description: Measured in mmHg
measure: Change in urine albumin
time frame: During 3 years before baseline (0 to -36 months)
description: Measured in mg/24 hours
measure: Change in urine albumin
time frame: During 3 years before baseline (0 to -36 months)
description: Measured in microgram/minute
measure: Change in glycosylated hemoglobin (HbA1c)
time frame: During 3 years before baseline (0 to -36 months)
description: Measured in mmol/mol
measure: Change in HbA1c
time frame: During 3 years before baseline (0 to -36 months)
description: Measured in %
measure: Change in Estimated Glomerular Filtration Rate (eGFR)
time frame: During 3 years before baseline (0 to -36 months)
description: Measured in mL/min/1.73 m^2
measure: Change in total cholesterol
time frame: During 3 years before baseline (0 to -36 months)
description: measured in mg/dl
measure: Change in low-density lipoprotein cholesterol
time frame: During 3 years before baseline (0 to -36 months)
description: measured in mg/dl
measure: Change in high-density lipoprotein cholesterol
time frame: During 3 years before baseline (0 to -36 months)
description: measured in mg/dl
measure: Change in triglyceride
time frame: During 3 years before baseline (0 to -36 months)
description: measured in mg/dl
measure: Type of pharmacological treatment
time frame: During 3 years before baseline (0 to -36 months)
description: Types of pharmacological treatment: Antidiabetics Antihypertensive Lipid lowering therapy Antiplatelet/anticoagulant therapy
arm group label: Patients with type 2 diabetes mellitus (T2DM)
description: Patients with type 2 diabetes, at the hospital setting.
arm group label: Patients with T2DM and established cardiovascular disease
description: Subgroup of patients with type 2 diabetes and established cardiovascular disease
intervention type: Other
intervention name: No treatment given
description: No treatment is administered to the participants for this study
arm group label: Patients with T2DM and established cardiovascular disease
arm group label: Patients with type 2 diabetes mellitus (T2DM)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Reporting Anchor and Disclosure (1452)
role: Study Director
affiliation: Novo Nordisk A/S
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Portugal
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 2
sharing ipd: Yes
ipd description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
ipd url: http://novonordisk-trials.com