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Diabetes Mellitus, Type 2CAPTURE-IONCT03811288

An International Survey of the Occurrence of Cardiovascular Disease Among Patients With Type 2 Diabetes

An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 164 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
No treatment given
How many people
7,548 participants
Where
164 sitesin 10 countries
Study dates
10 Dec 2018to 30 Sep 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

164 sites in 10 countries.

164 sites in 10 countries

Mexico31 sites

  • Novo Nordisk Investigational Site

    Acapulco de Juárez, Guerrero

  • Novo Nordisk Investigational Site

    Aguascalientes, 20230

  • Novo Nordisk Investigational Site

    Benito Juárez, México, D.F., 06720

  • Novo Nordisk Investigational Site

    Celaya, Guanajuato, 38000

  • Novo Nordisk Investigational Site

    Ciudad Madero, Tamaulipas, 89440

  • Novo Nordisk Investigational Site

    Cuauhtémoc, México, D.F., 06700

  • Novo Nordisk Investigational Site

    Cuernavaca, Morelos, 62250

  • Novo Nordisk Investigational Site

    Culiacán, Sinaloa, 80230

  • Novo Nordisk Investigational Site

    Guadalajara, Jalisco, 44340

  • Novo Nordisk Investigational Site

    Guadalajara, Jalisco, 44600

  • Novo Nordisk Investigational Site

    Guadalajara, Jalisco, 44657

  • Novo Nordisk Investigational Site

    Guadalajara, Jalisco, 44670

  • Novo Nordisk Investigational Site

    Guadalajara, 44600

  • Novo Nordisk Investigational Site

    Gustavo A. Madero, México, D.F., 07760

  • Novo Nordisk Investigational Site

    Hermosillo, Sonora, 83280

  • Novo Nordisk Investigational Site

    León, Guanajuato, 37150

  • Novo Nordisk Investigational Site

    México, State of Mexico, 52763

  • Novo Nordisk Investigational Site

    Mexico City, México, D.F., 03300

  • Novo Nordisk Investigational Site

    Mexico City, 11850

  • Novo Nordisk Investigational Site

    Monclova, Coahuila, 25750

  • Novo Nordisk Investigational Site

    Monterrey, Nuevo León, 64460

  • Novo Nordisk Investigational Site

    Monterrey, Nuevo León, 64718

  • Novo Nordisk Investigational Site

    Monterrey, 64700

  • Novo Nordisk Investigational Site

    Puerto Vallarta, Jalisco, 48328

  • Novo Nordisk Investigational Site

    Querétaro, 76000

  • Novo Nordisk Investigational Site

    San Luis Potosí City, San Luis Potosí, 78200

  • Novo Nordisk Investigational Site

    San Luis Potosí City, 78200

  • Novo Nordisk Investigational Site

    Tijuana, Baja California Norte, 22505

  • Novo Nordisk Investigational Site

    Veracruz, 91900

  • Novo Nordisk Investigational Site

    Zapopan, Jalisco, 45060

  • Novo Nordisk Investigational Site

    Zapopan, Jalisco, 45200

Other trials in Mexico

Brazil21 sites

  • Novo Nordisk Investigational Site

    Aparecida de Goiânia, Goiás, 74935-530

  • Novo Nordisk Investigational Site

    Belo Horizonte, Minas Gerais, 30140-062

  • Novo Nordisk Investigational Site

    Belo Horizonte, Minas Gerais, 30150-221

  • Novo Nordisk Investigational Site

    Campina Grande do Sul, Paraná, 83430-000

  • Novo Nordisk Investigational Site

    Campinas, São Paulo, 13010-001

  • Novo Nordisk Investigational Site

    Curitiba, Paraná, 80440-020

  • Novo Nordisk Investigational Site

    Curitiba, Paraná, 80810-040

  • Novo Nordisk Investigational Site

    Fortaleza, Ceará, 60192-340

  • Novo Nordisk Investigational Site

    Fortaleza, 60430-350

  • Novo Nordisk Investigational Site

    Goiânia, Goiás, 74605-020

  • Novo Nordisk Investigational Site

    Maringá, Paraná, 87015-180

  • Novo Nordisk Investigational Site

    Maringá, Paraná, 87060-040

  • Novo Nordisk Investigational Site

    Passo Fundo, Rio Grande do Sul, 99010-080

  • Novo Nordisk Investigational Site

    Porto Alegre, Rio Grande do Sul, 90020-090

  • Novo Nordisk Investigational Site

    Porto Alegre, Rio Grande do Sul, 90430-001

  • Novo Nordisk Investigational Site

    Santo André, São Paulo, 09030-340

  • Novo Nordisk Investigational Site

    São Paulo, São Paulo, 01228-200

  • Novo Nordisk Investigational Site

    São Paulo, 04266-010

  • Novo Nordisk Investigational Site

    Tatuí, São Paulo, 18270-170

  • Novo Nordisk Investigational Site

    Uberaba, Minas Gerais, 38025-260

  • Novo Nordisk Investigational Site

    Votuporanga, São Paulo, 15500-003

Other trials in Brazil

Japan19 sites

  • Novo Nordisk Investigational Site

    Chiba-shi, Chiba, 260-0804

  • Novo Nordisk Investigational Site

    Chuo-ku, Tokyo, 103-0002

  • Novo Nordisk Investigational Site

    Ebina-shi, Kanagawa, 243-0432

  • Novo Nordisk Investigational Site

    Fukushima, 963-8851

  • Novo Nordisk Investigational Site

    Hamamatsu-Shi Shizuoka, 430-8525

  • Novo Nordisk Investigational Site

    Hokkaido, 062-0007

  • Novo Nordisk Investigational Site

    Kanagawa, 235-0045

  • Novo Nordisk Investigational Site

    Kawagoe-shi, Saitama, 350-0851

  • Novo Nordisk Investigational Site

    Koshigaya-shi,Saitama

  • Novo Nordisk Investigational Site

    Kumamoto, 862-0976

  • Novo Nordisk Investigational Site

    Mito-shi, Ibaraki, 310-0826

  • Novo Nordisk Investigational Site

    Miyazaki, 880-0034

  • Novo Nordisk Investigational Site

    Nishi-ku Sapporo

  • Novo Nordisk Investigational Site

    Ōita, 870 0039

  • Novo Nordisk Investigational Site

    Okawa-shi, Fukuoka, 831-0016

  • Novo Nordisk Investigational Site

    Ota-ku, Tokyo, 1430015

  • Novo Nordisk Investigational Site

    Oyama-shi, 323 0022

  • Novo Nordisk Investigational Site

    Shimotsuke-shi, Tochigi, 329-0433

  • Novo Nordisk Investigational Site

    Shinjyuku-ku Tokyo, 160-0022

Other trials in Japan

Argentina18 sites

  • Novo Nordisk Investigational Site

    Buenos Aires, 1744

  • Novo Nordisk Investigational Site

    Buenos Aires, B1704ETD

  • Novo Nordisk Investigational Site

    Buenos Aires, B6000BHA

  • Novo Nordisk Investigational Site

    Buenos Aires, C1425AGC

  • Novo Nordisk Investigational Site

    CABA, C1120AAC

  • Novo Nordisk Investigational Site

    CABA, C1179AAB

  • Novo Nordisk Investigational Site

    CABA, C1440AAD

  • Novo Nordisk Investigational Site

    Chacabuco, B6740ELF

  • Novo Nordisk Investigational Site

    Córdoba, 5000

  • Novo Nordisk Investigational Site

    Córdoba, 5008

  • Novo Nordisk Investigational Site

    Córdoba, X5003DCE

  • Novo Nordisk Investigational Site

    Córdoba, X5016KEH

  • Novo Nordisk Investigational Site

    Coronel Suárez, B7540GHD

  • Novo Nordisk Investigational Site

    Godoy Cruz, M5501ARP

  • Novo Nordisk Investigational Site

    Lanús Este, B1824KAJ

  • Novo Nordisk Investigational Site

    Mar del Plata, B7600FZN

  • Novo Nordisk Investigational Site

    Mar del Plata, B7602CBM

  • Novo Nordisk Investigational Site

    Morón, B1708IFF

Other trials in Argentina

Australia18 sites

  • Novo Nordisk Investigational Site

    Blacktown, New South Wales, 2148

  • Novo Nordisk Investigational Site

    Brookvale, New South Wales, 2100

  • Novo Nordisk Investigational Site

    Campbelltown, New South Wales, 2560

  • Novo Nordisk Investigational Site

    Coffs Harbour, New South Wales, 2450

  • Novo Nordisk Investigational Site

    Forest Hill, Victoria, 3131

  • Novo Nordisk Investigational Site

    Fremantle, Western Australia, 6160

  • Novo Nordisk Investigational Site

    Geelong, 3220

  • Novo Nordisk Investigational Site

    Herston, Queensland, 4029

  • Novo Nordisk Investigational Site

    Maroubra, New South Wales, 2035

  • Novo Nordisk Investigational Site

    Moonee Ponds, Victoria, 3039

  • Novo Nordisk Investigational Site

    Morayfield, Queensland, 4506

  • Novo Nordisk Investigational Site

    North Ipswich, Queensland, 4305

  • Novo Nordisk Investigational Site

    Parkville, Victoria, 3052

  • Novo Nordisk Investigational Site

    Preston, Victoria, 3072

  • Novo Nordisk Investigational Site

    Ringwood, Victoria, 3134

  • Novo Nordisk Investigational Site

    Sherwood, Queensland, 4075

  • Novo Nordisk Investigational Site

    Victoria Point, Queensland, 4165

  • Novo Nordisk Investigational Site

    Wollongong, New South Wales, 2500

Other trials in Australia

Turkey (Türkiye)18 sites

  • Novo Nordisk Investigational Site

    Adana, 01250

  • Novo Nordisk Investigational Site

    Ankara, 06010

  • Novo Nordisk Investigational Site

    Ankara, 06100

  • Novo Nordisk Investigational Site

    Ankara, 06490

  • Novo Nordisk Investigational Site

    Antalya, 07058

  • Novo Nordisk Investigational Site

    Edirne, 22030

  • Novo Nordisk Investigational Site

    Elâzığ, 23200

  • Novo Nordisk Investigational Site

    Eskişehir, 26040

  • Novo Nordisk Investigational Site

    Istanbul, 34010

  • Novo Nordisk Investigational Site

    Istanbul, 34400

  • Novo Nordisk Investigational Site

    Istanbul, 34722

  • Novo Nordisk Investigational Site

    Istanbul, 34899

  • Novo Nordisk Investigational Site

    Istanbul

  • Novo Nordisk Investigational Site

    Izmir, 35340

  • Novo Nordisk Investigational Site

    Kayseri, 38280

  • Novo Nordisk Investigational Site

    Malatya, 44280

  • Novo Nordisk Investigational Site

    Tekirdağ, 59000

  • Novo Nordisk Investigational Site

    Zonguldak, 67000

Other trials in Turkey (Türkiye)

Israel16 sites

  • Novo Nordisk Investigational Site

    Bat Yam, 49100

  • Novo Nordisk Investigational Site

    Beer-Sheva HaDarom, 84350

  • Novo Nordisk Investigational Site

    Beersheba, 84101

  • Novo Nordisk Investigational Site

    Bnei Brak, 5136116

  • Novo Nordisk Investigational Site

    Haifa, 35152

  • Novo Nordisk Investigational Site

    Holon, 58100

  • Novo Nordisk Investigational Site

    Jerusalem, 91120

  • Novo Nordisk Investigational Site

    Jerusalem, 93106

  • Novo Nordisk Investigational Site

    Kiryat Bialik, 2723901

  • Novo Nordisk Investigational Site

    Nahariya, 22100

  • Novo Nordisk Investigational Site

    Nazareth

  • Novo Nordisk Investigational Site

    Petah Tikva, 49100

  • Novo Nordisk Investigational Site

    Raanana, 43452

  • Novo Nordisk Investigational Site

    Safed, 13100

  • Novo Nordisk Investigational Site

    Tel Aviv, 62038

  • Novo Nordisk Investigational Site

    Tel Aviv, 6937947

Other trials in Israel

China11 sites

  • Novo Nordisk Investigational Site

    Beijing, Beijing Municipality, 100191

  • Novo Nordisk Investigational Site

    Beijing, Beijing Municipality, 102500

  • Novo Nordisk Investigational Site

    Guangzhou, Guangdong, 510080

  • Novo Nordisk Investigational Site

    Guiyang, Guizhou, 550004

  • Novo Nordisk Investigational Site

    Lanzhou, Gansu, 730030

  • Novo Nordisk Investigational Site

    Luzhou, Sichuan, 646000

  • Novo Nordisk Investigational Site

    Nanchong, Sichuan, 637000

  • Novo Nordisk Investigational Site

    Nanjing, 210009

  • Novo Nordisk Investigational Site

    Ningbo, Zhejiang, 315010

  • Novo Nordisk Investigational Site

    Shanghai, Shanghai Municipality, 200135

  • Novo Nordisk Investigational Site

    Wuxi, Jiangsu, 214002

Other trials in China

Saudi Arabia7 sites

  • Novo Nordisk Investigational Site

    Al Ihsa, 36428

  • Novo Nordisk Investigational Site

    Buraidah, 52366

  • Novo Nordisk Investigational Site

    Jeddah, 22252

  • Novo Nordisk Investigational Site

    Riyadh, 12311

  • Novo Nordisk Investigational Site

    Riyadh, 12372

  • Novo Nordisk Investigational Site

    Riyadh, 245

  • Novo Nordisk Investigational Site

    Ta'if, 21944

Other trials in Saudi Arabia

Algeria5 sites

  • Novo Nordisk Investigational Site

    Algiers, 16000

  • Novo Nordisk Investigational Site

    Batna City, 05000

  • Novo Nordisk Investigational Site

    Constantine, 25000

  • Novo Nordisk Investigational Site

    Tiaret, 14000

  • Novo Nordisk Investigational Site

    Tizi Ouzou, 16015

Other trials in Algeria

About this study

Official title: 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.

Being tested
No treatment given
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No treatment givenOther

    No specific intervention is studied. All anti-diabetic and CV medication will be prescribed at the physician's discretion under routine clinical practice conditions.

Study groups in NCT03811288
Study groupRoleWhat they receive
Participants with type 2 diabetes mellitus (T2DM)T2DM patients being managed in both primary and specialist care in 10 selected countries.
Receives: Other: No treatment given

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Participants with a history of established cardiovascular disease (CVD)

    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.

    Measured: Day 1

Secondary outcomes (1)

  1. Participants with high risk of CVD according to the risk engine from the United Kingdom Prospective Diabetes Study (UKPDS)

    Percentage of participants (yes/no). High risk: more than 20 percent over 10 years.

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2019
  2. Study start10 Dec 2018
  3. Primary completion30 Sep 2019
  4. Study completion30 Sep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
7,548 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03811288
Sponsor's protocol ID
NN2211-4446
Other IDs
U1111-1215-4005
Acronym
CAPTURE-IO
Status last verified
Jun 2020
First submitted
18 Jan 2019
Last updated
9 Jun 2020
Results posted
No
Data monitoring committee
No
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Publications

  • Vencio S, Vianna AGD, da Silva MACF, Precoma DB. Contemporary (2019) prevalence of cardiovascular disease in adults with type 2 diabetes in Brazil: the cross-sectional CAPTURE study. Diabetol Metab Syndr. 2022 Jan 10;14(1):5. doi: 10.1186/s13098-021-00775-9.

    PubMed 35012646

  • Mosenzon O, Alguwaihes A, Leon JLA, Bayram F, Darmon P, Davis TME, Dieuzeide G, Eriksen KT, Hong T, Kaltoft MS, Lengyel C, Rhee NA, Russo GT, Shirabe S, Urbancova K, Vencio S; CAPTURE Study Investigators. CAPTURE: a multinational, cross-sectional study of cardiovascular disease prevalence in adults with type 2 diabetes across 13 countries. Cardiovasc Diabetol. 2021 Jul 27;20(1):154. doi: 10.1186/s12933-021-01344-0.

    PubMed 34315481

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 164 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 164 sites in Mexico, Brazil, Japan, Argentina, Australia and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participants with a history of established cardiovascular disease (CVD) (time frame: Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03811288, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.

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