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

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

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

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
Intervention / Treatment
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

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

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

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)

December 10, 2018

Primary Completion (ACTUAL)

September 30, 2019

Study Completion (ACTUAL)

September 30, 2019

Study Registration Dates

First Submitted

January 18, 2019

First Submitted That Met QC Criteria

January 18, 2019

First Posted (ACTUAL)

January 22, 2019

Study Record Updates

Last Update Posted (ACTUAL)

June 9, 2020

Last Update Submitted That Met QC Criteria

June 5, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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