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

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Other: No treatment given

• Registration Number: NCT03811288
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-12-10
• Study First Submitted: 2019-01-18
• Study First Submitted QC: 2019-01-18
• Study First Posted: 2019-01-22
• Primary Completion: 2019-09-30
• Study Completion: 2019-09-30
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-05
• Last Update Posted: 2020-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7548

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants with type 2 diabetes mellitus (T2DM)	No treatment given	T2DM patients being managed in both primary and specialist care in 10 selected countries.

Primary Outcome Measures

Name	Time	Method
Participants with a history of established cardiovascular disease (CVD)	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 Outcome Measures

Name	Time	Method
Participants with high risk of CVD according to the risk engine from the United Kingdom Prospective Diabetes Study (UKPDS)	Day 1	Percentage of participants (yes/no). High risk: more than 20 percent over 10 years.

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇹🇷 Zonguldak, Turkey