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Clinical Trials/NCT03811288
NCT03811288
Completed
Not Applicable

A Non-interventional Cross-sectional Study to Capture the Prevalence of Cardiovascular Disease in Patients With Type 2 Diabetes - an International Observation

Novo Nordisk A/S1 site in 1 country7,548 target enrollmentDecember 10, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus, Type 2
Sponsor
Novo Nordisk A/S
Enrollment
7548
Locations
1
Primary Endpoint
Participants with a history of established cardiovascular disease (CVD)
Status
Completed
Last Updated
5 years ago

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.

Registry
clinicaltrials.gov
Start Date
December 10, 2018
End Date
September 30, 2019
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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)

Study Sites (1)

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