A Non-interventional Cross-sectional Study to Capture the Prevalence of Cardiovascular Disease in Patients With Type 2 Diabetes - an International Observation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 7,548
- Locations
- 1
- Primary Endpoint
- Participants with a history of established cardiovascular disease (CVD)
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Participants with high risk of CVD according to the risk engine from the United Kingdom Prospective Diabetes Study (UKPDS)(Day 1)