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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03811288
Other study ID # NN2211-4446
Secondary ID U1111-1215-4005
Status Completed
Phase
First received
Last updated
Start date December 10, 2018
Est. completion date September 30, 2019

Study information

Verified date June 2020
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

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

Study Design


Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Algeria,  Argentina,  Australia,  Brazil,  China,  Israel,  Japan,  Mexico,  Saudi Arabia,  Turkey, 

Outcome

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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