Diabetes Mellitus, Type 2 Clinical Trial
— CAPTURE-IOOfficial title:
A Non-interventional Cross-sectional Study to Capture the Prevalence of Cardiovascular Disease in Patients With Type 2 Diabetes - an International Observation
| Verified date | June 2020 |
| Source | Novo Nordisk A/S |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 7548 |
| Est. completion date | September 30, 2019 |
| Est. primary completion date | September 30, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Algeria | Novo Nordisk Investigational Site | Algiers | |
| Algeria | Novo Nordisk Investigational Site | Batna | |
| Algeria | Novo Nordisk Investigational Site | Constantine | |
| Algeria | Novo Nordisk Investigational Site | Tiaret | |
| Algeria | Novo Nordisk Investigational Site | Tizi Ouzou | |
| Argentina | Novo Nordisk Investigational Site | Buenos Aires | |
| Argentina | Novo Nordisk Investigational Site | Buenos Aires | |
| Argentina | Novo Nordisk Investigational Site | Buenos Aires | |
| Argentina | Novo Nordisk Investigational Site | Buenos Aires | |
| Argentina | Novo Nordisk Investigational Site | Caba | |
| Argentina | Novo Nordisk Investigational Site | Caba | |
| Argentina | Novo Nordisk Investigational Site | Caba | |
| Argentina | Novo Nordisk Investigational Site | Chacabuco | |
| Argentina | Novo Nordisk Investigational Site | Cordoba | |
| Argentina | Novo Nordisk Investigational Site | Córdoba | |
| Argentina | Novo Nordisk Investigational Site | Córdoba | |
| Argentina | Novo Nordisk Investigational Site | Córdoba | |
| Argentina | Novo Nordisk Investigational Site | Coronel Suarez | |
| Argentina | Novo Nordisk Investigational Site | Godoy Cruz | |
| Argentina | Novo Nordisk Investigational Site | Lanus Este | |
| Argentina | Novo Nordisk Investigational Site | Mar del Plata | |
| Argentina | Novo Nordisk Investigational Site | Mar del Plata | |
| Argentina | Novo Nordisk Investigational Site | Morón | |
| Australia | Novo Nordisk Investigational Site | Blacktown | New South Wales |
| Australia | Novo Nordisk Investigational Site | Brookvale | New South Wales |
| Australia | Novo Nordisk Investigational Site | Campbelltown | New South Wales |
| Australia | Novo Nordisk Investigational Site | Coffs Harbour | New South Wales |
| Australia | Novo Nordisk Investigational Site | Forest Hill | Victoria |
| Australia | Novo Nordisk Investigational Site | Fremantle | Western Australia |
| Australia | Novo Nordisk Investigational Site | Geelong | |
| Australia | Novo Nordisk Investigational Site | Herston | Queensland |
| Australia | Novo Nordisk Investigational Site | Maroubra | New South Wales |
| Australia | Novo Nordisk Investigational Site | Moonee Ponds | Victoria |
| Australia | Novo Nordisk Investigational Site | Morayfield | Queensland |
| Australia | Novo Nordisk Investigational Site | North Ipswich | Queensland |
| Australia | Novo Nordisk Investigational Site | Parkville | Victoria |
| Australia | Novo Nordisk Investigational Site | Preston | Victoria |
| Australia | Novo Nordisk Investigational Site | Ringwood | Victoria |
| Australia | Novo Nordisk Investigational Site | Sherwood | Queensland |
| Australia | Novo Nordisk Investigational Site | Victoria Point | Queensland |
| Australia | Novo Nordisk Investigational Site | Wollongong | New South Wales |
| Brazil | Novo Nordisk Investigational Site | Aparecida de Goiania | Goias |
| Brazil | Novo Nordisk Investigational Site | Belo Horizonte | Minas Gerais |
| Brazil | Novo Nordisk Investigational Site | Belo Horizonte | Minas Gerais |
| Brazil | Novo Nordisk Investigational Site | Campina Grande do Sul | Parana |
| Brazil | Novo Nordisk Investigational Site | Campinas | Sao Paulo |
| Brazil | Novo Nordisk Investigational Site | Curitiba | Parana |
| Brazil | Novo Nordisk Investigational Site | Curitiba | Parana |
| Brazil | Novo Nordisk Investigational Site | Fortaleza | Ceara |
| Brazil | Novo Nordisk Investigational Site | Fortaleza | |
| Brazil | Novo Nordisk Investigational Site | Goiânia | Goias |
| Brazil | Novo Nordisk Investigational Site | Maringa | Parana |
| Brazil | Novo Nordisk Investigational Site | Maringa | Parana |
| Brazil | Novo Nordisk Investigational Site | Passo Fundo | Rio Grande Do Sul |
| Brazil | Novo Nordisk Investigational Site | Porto Alegre | Rio Grande Do Sul |
| Brazil | Novo Nordisk Investigational Site | Porto Alegre | Rio Grande Do Sul |
| Brazil | Novo Nordisk Investigational Site | Santo André | Sao Paulo |
| Brazil | Novo Nordisk Investigational Site | Sao Paulo | |
| Brazil | Novo Nordisk Investigational Site | São Paulo | Sao Paulo |
| Brazil | Novo Nordisk Investigational Site | Tatui | Sao Paulo |
| Brazil | Novo Nordisk Investigational Site | Uberaba | Minas Gerais |
| Brazil | Novo Nordisk Investigational Site | Votuporanga | Sao Paulo |
| China | Novo Nordisk Investigational Site | Beijing | Beijing |
| China | Novo Nordisk Investigational Site | Beijing | Beijing |
| China | Novo Nordisk Investigational Site | Guangzhou | Guangdong |
| China | Novo Nordisk Investigational Site | Guiyang | Guizhou |
| China | Novo Nordisk Investigational Site | Lanzhou | Gansu |
| China | Novo Nordisk Investigational Site | Luzhou | Sichuan |
| China | Novo Nordisk Investigational Site | Nanchong | Sichuan |
| China | Novo Nordisk Investigational Site | Nanjing | |
| China | Novo Nordisk Investigational Site | Ningbo | Zhejiang |
| China | Novo Nordisk Investigational Site | Shanghai | Shanghai |
| China | Novo Nordisk Investigational Site | Wuxi | Jiangsu |
| Israel | Novo Nordisk Investigational Site | Bat Yam | |
| Israel | Novo Nordisk Investigational Site | Beer sheva | |
| Israel | Novo Nordisk Investigational Site | Beer-Sheva HaDarom | |
| Israel | Novo Nordisk Investigational Site | Bnei Brak | |
| Israel | Novo Nordisk Investigational Site | Haifa | |
| Israel | Novo Nordisk Investigational Site | Holon | |
| Israel | Novo Nordisk Investigational Site | Jerusalem | |
| Israel | Novo Nordisk Investigational Site | Jerusalem | |
| Israel | Novo Nordisk Investigational Site | Kiryat Bialik | |
| Israel | Novo Nordisk Investigational Site | Nahariya | |
| Israel | Novo Nordisk Investigational Site | Nazareth | |
| Israel | Novo Nordisk Investigational Site | Petach Tikva | |
| Israel | Novo Nordisk Investigational Site | Petah-Tikva | |
| Israel | Novo Nordisk Investigational Site | Ra'anana | |
| Israel | Novo Nordisk Investigational Site | Tel Aviv | |
| Israel | Novo Nordisk Investigational Site | Tel-Aviv | |
| Israel | Novo Nordisk Investigational Site | Zefat | |
| Japan | Novo Nordisk Investigational Site | Chiba-shi, Chiba | |
| Japan | Novo Nordisk Investigational Site | Chuo-ku, Tokyo | |
| Japan | Novo Nordisk Investigational Site | Ebina-shi, Kanagawa | |
| Japan | Novo Nordisk Investigational Site | Fukushima | |
| Japan | Novo Nordisk Investigational Site | Hamamatsu-Shi Shizuoka | |
| Japan | Novo Nordisk Investigational Site | Hokkaido | |
| Japan | Novo Nordisk Investigational Site | Kanagawa | |
| Japan | Novo Nordisk Investigational Site | Kawagoe-shi, Saitama | |
| Japan | Novo Nordisk Investigational Site | Koshigaya-shi,Saitama | |
| Japan | Novo Nordisk Investigational Site | Kumamoto | |
| Japan | Novo Nordisk Investigational Site | Mito-shi, Ibaraki | |
| Japan | Novo Nordisk Investigational Site | Miyazaki | |
| Japan | Novo Nordisk Investigational Site | Nishi-ku Sapporo | |
| Japan | Novo Nordisk Investigational Site | Oita-shi | |
| Japan | Novo Nordisk Investigational Site | Okawa-shi, Fukuoka | |
| Japan | Novo Nordisk Investigational Site | Ota-ku, Tokyo | |
| Japan | Novo Nordisk Investigational Site | Oyama-shi | |
| Japan | Novo Nordisk Investigational Site | Shimotsuke-shi, Tochigi | |
| Japan | Novo Nordisk Investigational Site | Shinjyuku-ku Tokyo | |
| Mexico | Novo Nordisk Investigational Site | Acapulco de Juarez | Guerrero |
| Mexico | Novo Nordisk Investigational Site | Aguascalientes | |
| Mexico | Novo Nordisk Investigational Site | Benito Juárez | México, D.F. |
| Mexico | Novo Nordisk Investigational Site | Celaya | Guanajuato |
| Mexico | Novo Nordisk Investigational Site | Ciudad Madero | Tamaulipas |
| Mexico | Novo Nordisk Investigational Site | Cuauhtemoc | México, D.F. |
| Mexico | Novo Nordisk Investigational Site | Cuernavaca | Morelos |
| Mexico | Novo Nordisk Investigational Site | Culiacán | Sinaloa |
| Mexico | Novo Nordisk Investigational Site | Guadalajara | Jalisco |
| Mexico | Novo Nordisk Investigational Site | Guadalajara | Jalisco |
| Mexico | Novo Nordisk Investigational Site | Guadalajara | Jalisco |
| Mexico | Novo Nordisk Investigational Site | Guadalajara | Jalisco |
| Mexico | Novo Nordisk Investigational Site | Guadalajara | |
| Mexico | Novo Nordisk Investigational Site | Gustavo A Madero | México, D.F. |
| Mexico | Novo Nordisk Investigational Site | Hermosillo | Sonora |
| Mexico | Novo Nordisk Investigational Site | León | Guanajuato |
| Mexico | Novo Nordisk Investigational Site | Mexico | Estado De México |
| Mexico | Novo Nordisk Investigational Site | Mexico City | |
| Mexico | Novo Nordisk Investigational Site | Mexico City | México, D.F. |
| Mexico | Novo Nordisk Investigational Site | Monclova | Coahuila |
| Mexico | Novo Nordisk Investigational Site | Monterrey | |
| Mexico | Novo Nordisk Investigational Site | Monterrey | Nuevo León |
| Mexico | Novo Nordisk Investigational Site | Monterrey | Nuevo León |
| Mexico | Novo Nordisk Investigational Site | Puerto Vallarta | Jalisco |
| Mexico | Novo Nordisk Investigational Site | Queretaro | |
| Mexico | Novo Nordisk Investigational Site | San Luis Potosi | |
| Mexico | Novo Nordisk Investigational Site | San Luis Potosí | San Luis Potosi |
| Mexico | Novo Nordisk Investigational Site | Tijuana | Baja California Norte |
| Mexico | Novo Nordisk Investigational Site | Veracruz | |
| Mexico | Novo Nordisk Investigational Site | Zapopan | Jalisco |
| Mexico | Novo Nordisk Investigational Site | Zapopan | Jalisco |
| Saudi Arabia | Novo Nordisk Investigational Site | Al Ihsa | |
| Saudi Arabia | Novo Nordisk Investigational Site | Buraydah | |
| Saudi Arabia | Novo Nordisk Investigational Site | Jeddah | |
| Saudi Arabia | Novo Nordisk Investigational Site | Riyadh | |
| Saudi Arabia | Novo Nordisk Investigational Site | Riyadh | |
| Saudi Arabia | Novo Nordisk Investigational Site | Riyadh | |
| Saudi Arabia | Novo Nordisk Investigational Site | Taif | |
| Turkey | Novo Nordisk Investigational Site | Adana | |
| Turkey | Novo Nordisk Investigational Site | Ankara | |
| Turkey | Novo Nordisk Investigational Site | Ankara | |
| Turkey | Novo Nordisk Investigational Site | Ankara | |
| Turkey | Novo Nordisk Investigational Site | Antalya | |
| Turkey | Novo Nordisk Investigational Site | Edirne | |
| Turkey | Novo Nordisk Investigational Site | Elazig | |
| Turkey | Novo Nordisk Investigational Site | Eskisehir | |
| Turkey | Novo Nordisk Investigational Site | Istanbul | |
| Turkey | Novo Nordisk Investigational Site | Istanbul | |
| Turkey | Novo Nordisk Investigational Site | Istanbul | |
| Turkey | Novo Nordisk Investigational Site | Istanbul | |
| Turkey | Novo Nordisk Investigational Site | Istanbul | |
| Turkey | Novo Nordisk Investigational Site | Izmir | |
| Turkey | Novo Nordisk Investigational Site | Kayseri | |
| Turkey | Novo Nordisk Investigational Site | Malatya | |
| Turkey | Novo Nordisk Investigational Site | Tekirdag | |
| Turkey | Novo Nordisk Investigational Site | Zonguldak |
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
Algeria, Argentina, Australia, Brazil, China, Israel, Japan, Mexico, Saudi Arabia, Turkey,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Day 1 | |
| Secondary | 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. | Day 1 |
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