An International Survey of the Occurrence of Cardiovascular Disease Among Patients With Type 2 Diabetes (CAPTURE-IO)

June 5, 2020 updated by: Novo Nordisk A/S

A Non-interventional Cross-sectional Study to Capture the Prevalence of Cardiovascular Disease in Patients With Type 2 Diabetes - an International Observation

The purpose of the study is to register the occurrence of cardiovascular disease among type 2 diabetes patients across ten countries across the world. Participants will be asked to give information about their health. Participants will continue their normal way of life and will not get any medication other than prescribed to them by their doctor. Participants' participation will be one day/one visit at their doctor. The study will last for about 6 months in total.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7548

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Algeria
      • Algiers, Algeria, 16000
        • Novo Nordisk Investigational Site
      • Batna, Algeria, 05000
        • Novo Nordisk Investigational Site
      • Constantine, Algeria, 25000
        • Novo Nordisk Investigational Site
      • Tiaret, Algeria, 14000
        • Novo Nordisk Investigational Site
      • Tizi Ouzou, Algeria, 16015
        • Novo Nordisk Investigational Site
  • Argentina
      • Buenos Aires, Argentina, C1425AGC
        • Novo Nordisk Investigational Site
      • Buenos Aires, Argentina, B1704ETD
        • Novo Nordisk Investigational Site
      • Buenos Aires, Argentina, B6000BHA
        • Novo Nordisk Investigational Site
      • Buenos Aires, Argentina, 1744
        • Novo Nordisk Investigational Site
      • Caba, Argentina, C1179AAB
        • Novo Nordisk Investigational Site
      • Caba, Argentina, C1440AAD
        • Novo Nordisk Investigational Site
      • Caba, Argentina, C1120AAC
        • Novo Nordisk Investigational Site
      • Chacabuco, Argentina, B6740ELF
        • Novo Nordisk Investigational Site
      • Cordoba, Argentina, 5000
        • Novo Nordisk Investigational Site
      • Coronel Suarez, Argentina, B7540GHD
        • Novo Nordisk Investigational Site
      • Córdoba, Argentina, 5008
        • Novo Nordisk Investigational Site
      • Córdoba, Argentina, X5003DCE
        • Novo Nordisk Investigational Site
      • Córdoba, Argentina, X5016KEH
        • Novo Nordisk Investigational Site
      • Godoy Cruz, Argentina, M5501ARP
        • Novo Nordisk Investigational Site
      • Lanus Este, Argentina, B1824KAJ
        • Novo Nordisk Investigational Site
      • Mar del Plata, Argentina, B7600FZN
        • Novo Nordisk Investigational Site
      • Mar del Plata, Argentina, B7602CBM
        • Novo Nordisk Investigational Site
      • Morón, Argentina, B1708IFF
        • Novo Nordisk Investigational Site
  • Australia
      • Geelong, Australia, 3220
        • Novo Nordisk Investigational Site
    • New South Wales
      • Blacktown, New South Wales, Australia, 2148
        • Novo Nordisk Investigational Site
      • Brookvale, New South Wales, Australia, 2100
        • Novo Nordisk Investigational Site
      • Campbelltown, New South Wales, Australia, 2560
        • Novo Nordisk Investigational Site
      • Coffs Harbour, New South Wales, Australia, 2450
        • Novo Nordisk Investigational Site
      • Maroubra, New South Wales, Australia, 2035
        • Novo Nordisk Investigational Site
      • Wollongong, New South Wales, Australia, 2500
        • Novo Nordisk Investigational Site
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Novo Nordisk Investigational Site
      • Morayfield, Queensland, Australia, 4506
        • Novo Nordisk Investigational Site
      • North Ipswich, Queensland, Australia, 4305
        • Novo Nordisk Investigational Site
      • Sherwood, Queensland, Australia, 4075
        • Novo Nordisk Investigational Site
      • Victoria Point, Queensland, Australia, 4165
        • Novo Nordisk Investigational Site
    • Victoria
      • Forest Hill, Victoria, Australia, 3131
        • Novo Nordisk Investigational Site
      • Moonee Ponds, Victoria, Australia, 3039
        • Novo Nordisk Investigational Site
      • Parkville, Victoria, Australia, 3052
        • Novo Nordisk Investigational Site
      • Preston, Victoria, Australia, 3072
        • Novo Nordisk Investigational Site
      • Ringwood, Victoria, Australia, 3134
        • Novo Nordisk Investigational Site
    • Western Australia
      • Fremantle, Western Australia, Australia, 6160
        • Novo Nordisk Investigational Site
  • Brazil
      • Fortaleza, Brazil, 60430-350
        • Novo Nordisk Investigational Site
      • Sao Paulo, Brazil, 04266-010
        • Novo Nordisk Investigational Site
    • Ceara
      • Fortaleza, Ceara, Brazil, 60192-340
        • Novo Nordisk Investigational Site
    • Goias
      • Aparecida de Goiania, Goias, Brazil, 74935-530
        • Novo Nordisk Investigational Site
      • Goiânia, Goias, Brazil, 74605-020
        • Novo Nordisk Investigational Site
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30140-062
        • Novo Nordisk Investigational Site
      • Belo Horizonte, Minas Gerais, Brazil, 30150-221
        • Novo Nordisk Investigational Site
      • Uberaba, Minas Gerais, Brazil, 38025-260
        • Novo Nordisk Investigational Site
    • Parana
      • Campina Grande do Sul, Parana, Brazil, 83430-000
        • Novo Nordisk Investigational Site
      • Curitiba, Parana, Brazil, 80440-020
        • Novo Nordisk Investigational Site
      • Curitiba, Parana, Brazil, 80810-040
        • Novo Nordisk Investigational Site
      • Maringa, Parana, Brazil, 87015-180
        • Novo Nordisk Investigational Site
      • Maringa, Parana, Brazil, 87060-040
        • Novo Nordisk Investigational Site
    • Rio Grande Do Sul
      • Passo Fundo, Rio Grande Do Sul, Brazil, 99010-080
        • Novo Nordisk Investigational Site
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90430-001
        • Novo Nordisk Investigational Site
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90020-090
        • Novo Nordisk Investigational Site
    • Sao Paulo
      • Campinas, Sao Paulo, Brazil, 13010-001
        • Novo Nordisk Investigational Site
      • Santo André, Sao Paulo, Brazil, 09030-340
        • Novo Nordisk Investigational Site
      • São Paulo, Sao Paulo, Brazil, 01228-200
        • Novo Nordisk Investigational Site
      • Tatui, Sao Paulo, Brazil, 18270-170
        • Novo Nordisk Investigational Site
      • Votuporanga, Sao Paulo, Brazil, 15500-003
        • Novo Nordisk Investigational Site
  • China
      • Nanjing, China, 210009
        • Novo Nordisk Investigational Site
    • Beijing
      • Beijing, Beijing, China, 100191
        • Novo Nordisk Investigational Site
      • Beijing, Beijing, China, 102500
        • Novo Nordisk Investigational Site
    • Gansu
      • Lanzhou, Gansu, China, 730030
        • Novo Nordisk Investigational Site
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Novo Nordisk Investigational Site
    • Guizhou
      • Guiyang, Guizhou, China, 550004
        • Novo Nordisk Investigational Site
    • Jiangsu
      • Wuxi, Jiangsu, China, 214002
        • Novo Nordisk Investigational Site
    • Shanghai
      • Shanghai, Shanghai, China, 200135
        • Novo Nordisk Investigational Site
    • Sichuan
      • Luzhou, Sichuan, China, 646000
        • Novo Nordisk Investigational Site
      • Nanchong, Sichuan, China, 637000
        • Novo Nordisk Investigational Site
    • Zhejiang
      • Ningbo, Zhejiang, China, 315010
        • Novo Nordisk Investigational Site
  • Israel
      • Bat Yam, Israel, 49100
        • Novo Nordisk Investigational Site
      • Beer sheva, Israel, 84101
        • Novo Nordisk Investigational Site
      • Beer-Sheva HaDarom, Israel, 84350
        • Novo Nordisk Investigational Site
      • Bnei Brak, Israel, 5136116
        • Novo Nordisk Investigational Site
      • Haifa, Israel, 35152
        • Novo Nordisk Investigational Site
      • Holon, Israel, 58100
        • Novo Nordisk Investigational Site
      • Jerusalem, Israel, 91120
        • Novo Nordisk Investigational Site
      • Jerusalem, Israel, 93106
        • Novo Nordisk Investigational Site
      • Kiryat Bialik, Israel, 2723901
        • Novo Nordisk Investigational Site
      • Nahariya, Israel, 22100
        • Novo Nordisk Investigational Site
      • Nazareth, Israel
        • Novo Nordisk Investigational Site
      • Petach Tikva, Israel, 49100
        • Novo Nordisk Investigational Site
      • Petah-Tikva, Israel, 49100
        • Novo Nordisk Investigational Site
      • Ra'anana, Israel, 43452
        • Novo Nordisk Investigational Site
      • Tel Aviv, Israel, 6937947
        • Novo Nordisk Investigational Site
      • Tel-Aviv, Israel, 62038
        • Novo Nordisk Investigational Site
      • Zefat, Israel, 13100
        • Novo Nordisk Investigational Site
  • Japan
      • Chiba-shi, Chiba, Japan, 260-0804
        • Novo Nordisk Investigational Site
      • Chuo-ku, Tokyo, Japan, 103-0002
        • Novo Nordisk Investigational Site
      • Ebina-shi, Kanagawa, Japan, 243-0432
        • Novo Nordisk Investigational Site
      • Fukushima, Japan, 963-8851
        • Novo Nordisk Investigational Site
      • Hamamatsu-Shi Shizuoka, Japan, 430-8525
        • Novo Nordisk Investigational Site
      • Hokkaido, Japan, 062-0007
        • Novo Nordisk Investigational Site
      • Kanagawa, Japan, 235-0045
        • Novo Nordisk Investigational Site
      • Kawagoe-shi, Saitama, Japan, 350-0851
        • Novo Nordisk Investigational Site
      • Koshigaya-shi,Saitama, Japan
        • Novo Nordisk Investigational Site
      • Kumamoto, Japan, 862-0976
        • Novo Nordisk Investigational Site
      • Mito-shi, Ibaraki, Japan, 310-0826
        • Novo Nordisk Investigational Site
      • Miyazaki, Japan, 880-0034
        • Novo Nordisk Investigational Site
      • Nishi-ku Sapporo, Japan
        • Novo Nordisk Investigational Site
      • Oita-shi, Japan, 870 0039
        • Novo Nordisk Investigational Site
      • Okawa-shi, Fukuoka, Japan, 831-0016
        • Novo Nordisk Investigational Site
      • Ota-ku, Tokyo, Japan, 1430015
        • Novo Nordisk Investigational Site
      • Oyama-shi, Japan, 323 0022
        • Novo Nordisk Investigational Site
      • Shimotsuke-shi, Tochigi, Japan, 329-0433
        • Novo Nordisk Investigational Site
      • Shinjyuku-ku Tokyo, Japan, 160-0022
        • Novo Nordisk Investigational Site
  • Mexico
      • Aguascalientes, Mexico, 20230
        • Novo Nordisk Investigational Site
      • Guadalajara, Mexico, 44600
        • Novo Nordisk Investigational Site
      • Mexico City, Mexico, 11850
        • Novo Nordisk Investigational Site
      • Monterrey, Mexico, 64700
        • Novo Nordisk Investigational Site
      • Queretaro, Mexico, 76000
        • Novo Nordisk Investigational Site
      • San Luis Potosi, Mexico, 78200
        • Novo Nordisk Investigational Site
      • Veracruz, Mexico, 91900
        • Novo Nordisk Investigational Site
    • Baja California Norte
      • Tijuana, Baja California Norte, Mexico, 22505
        • Novo Nordisk Investigational Site
    • Coahuila
      • Monclova, Coahuila, Mexico, 25750
        • Novo Nordisk Investigational Site
    • Estado De México
      • Mexico, Estado De México, Mexico, 52763
        • Novo Nordisk Investigational Site
    • Guanajuato
      • Celaya, Guanajuato, Mexico, 38000
        • Novo Nordisk Investigational Site
      • León, Guanajuato, Mexico, 37150
        • Novo Nordisk Investigational Site
    • Guerrero
      • Acapulco de Juarez, Guerrero, Mexico
        • Novo Nordisk Investigational Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44600
        • Novo Nordisk Investigational Site
      • Guadalajara, Jalisco, Mexico, 44670
        • Novo Nordisk Investigational Site
      • Guadalajara, Jalisco, Mexico, 44340
        • Novo Nordisk Investigational Site
      • Guadalajara, Jalisco, Mexico, 44657
        • Novo Nordisk Investigational Site
      • Puerto Vallarta, Jalisco, Mexico, 48328
        • Novo Nordisk Investigational Site
      • Zapopan, Jalisco, Mexico, 45060
        • Novo Nordisk Investigational Site
      • Zapopan, Jalisco, Mexico, 45200
        • Novo Nordisk Investigational Site
    • Morelos
      • Cuernavaca, Morelos, Mexico, 62250
        • Novo Nordisk Investigational Site
    • México, D.F.
      • Benito Juárez, México, D.F., Mexico, 06720
        • Novo Nordisk Investigational Site
      • Cuauhtemoc, México, D.F., Mexico, 06700
        • Novo Nordisk Investigational Site
      • Gustavo A Madero, México, D.F., Mexico, 07760
        • Novo Nordisk Investigational Site
      • Mexico City, México, D.F., Mexico, 03300
        • Novo Nordisk Investigational Site
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Novo Nordisk Investigational Site
      • Monterrey, Nuevo León, Mexico, 64718
        • Novo Nordisk Investigational Site
    • San Luis Potosi
      • San Luis Potosí, San Luis Potosi, Mexico, 78200
        • Novo Nordisk Investigational Site
    • Sinaloa
      • Culiacán, Sinaloa, Mexico, 80230
        • Novo Nordisk Investigational Site
    • Sonora
      • Hermosillo, Sonora, Mexico, 83280
        • Novo Nordisk Investigational Site
    • Tamaulipas
      • Ciudad Madero, Tamaulipas, Mexico, 89440
        • Novo Nordisk Investigational Site
  • Saudi Arabia
      • Al Ihsa, Saudi Arabia, 36428
        • Novo Nordisk Investigational Site
      • Buraydah, Saudi Arabia, 52366
        • Novo Nordisk Investigational Site
      • Jeddah, Saudi Arabia, 22252
        • Novo Nordisk Investigational Site
      • Riyadh, Saudi Arabia, 12372
        • Novo Nordisk Investigational Site
      • Riyadh, Saudi Arabia, 245
        • Novo Nordisk Investigational Site
      • Riyadh, Saudi Arabia, 12311
        • Novo Nordisk Investigational Site
      • Taif, Saudi Arabia, 21944
        • Novo Nordisk Investigational Site
  • Turkey
      • Adana, Turkey, 01250
        • Novo Nordisk Investigational Site
      • Ankara, Turkey, 06100
        • Novo Nordisk Investigational Site
      • Ankara, Turkey, 06010
        • Novo Nordisk Investigational Site
      • Ankara, Turkey, 06490
        • Novo Nordisk Investigational Site
      • Antalya, Turkey, 07058
        • Novo Nordisk Investigational Site
      • Edirne, Turkey, 22030
        • Novo Nordisk Investigational Site
      • Elazig, Turkey, 23200
        • Novo Nordisk Investigational Site
      • Eskisehir, Turkey, 26040
        • Novo Nordisk Investigational Site
      • Istanbul, Turkey, 34722
        • Novo Nordisk Investigational Site
      • Istanbul, Turkey, 34899
        • Novo Nordisk Investigational Site
      • Istanbul, Turkey, 34010
        • Novo Nordisk Investigational Site
      • Istanbul, Turkey, 34400
        • Novo Nordisk Investigational Site
      • Istanbul, Turkey
        • Novo Nordisk Investigational Site
      • Izmir, Turkey, 35340
        • Novo Nordisk Investigational Site
      • Kayseri, Turkey, 38280
        • Novo Nordisk Investigational Site
      • Malatya, Turkey, 44280
        • Novo Nordisk Investigational Site
      • Tekirdag, Turkey, 59000
        • Novo Nordisk Investigational Site
      • Zonguldak, Turkey, 67000
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of male and female adults diagnosed with T2DM.

Description

Inclusion Criteria:

  • Signed informed consent obtained before any study-related activities (study-related activities are any procedures related to recording of data according to protocol)
  • Male or female, age more than or equal to 18 years at the time of signing informed consent (in Algeria more than or equal to 19 years; in Japan more than or equal to 20 years).
  • Diagnosed with T2DM more than or equal to 180 days prior to the day of signing the informed consent

Exclusion Criteria:

  • Previous participation in this study. Participation is defined as having given informed consent in this study
  • Diagnosed with Type 1 diabetes
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
  • Patients with known congenital heart disease/malformation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Participants with type 2 diabetes mellitus (T2DM)
T2DM patients being managed in both primary and specialist care in 10 selected countries.
Other: No treatment given
No specific intervention is studied. All anti-diabetic and CV medication will be prescribed at the physician's discretion under routine clinical practice conditions.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Participants with a history of established cardiovascular disease (CVD)
Time Frame: Day 1
Participants having a history of established CVD, i.e. who have been diagnosed with any one of the following listed conditions (yes/no): Cerebrovascular disease, cardiovascular disease, symptomatic heart failure, asymptomatic heart failure, hospitalisation for heart failure, cardiac arrhythmia, aortic disease, peripheral artery disease or carotid artery disease.
Day 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Participants with high risk of CVD according to the risk engine from the United Kingdom Prospective Diabetes Study (UKPDS)
Time Frame: Day 1
Percentage of participants (yes/no). High risk: more than 20 percent over 10 years.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 10, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 18, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 9, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NN2211-4446
  • U1111-1215-4005 (OTHER: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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