An International Survey of the Occurrence of Diseases That Affects the Heart and Blood Vessels Among People With Type 2 Diabetes

Completed

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

• Registration Number: NCT03786406
• 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 (T2DM) patients across five selected countries in Europe. 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 what has been prescribed to them by their doctor. Participants' participation will be one day/one visit at study doctor. The study will last for about 3 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: 2018-12-03
• Study First Submitted: 2018-12-20
• Study First Submitted QC: 2018-12-20
• Study First Posted: 2018-12-26
• Primary Completion: 2019-05-31
• Study Completion: 2019-05-31
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-19
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2275

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 greater than or equal to 18 years at the time of signing informed consent
• Diagnosed with type 2 diabetes mellitus greater 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
T2DM patients seen in routine practice	No treatment given	All anti-diabetic and cardiovascular (CV) medication will be prescribed at the physician's discretion under routine clinical practice conditions.

Primary Outcome Measures

Name	Time	Method
Diagnosed with peripheral artery disease: Asymptomatic peripheral arterial disease (PAD) defined as Low Ankle-Brachial Index (less than 0.90) or pulse abolition, claudication, limb ischemia and/or non-traumatic amputation	Day 1	Percentage of participants (Y/N).
Diagnosed with symptomatic heart failure: New York Heart Association Functional Classification (NYHA) (group IIIV) and/or left ventricular ejection fraction (LVEF) greater than or equal to 50 percent, LVEF 40-49 percent and LVEF less than 40 percent)	Day 1	Percentage of participants (Y/N).
Diagnosed with asymptomatic heart failure	Day 1	Percentage of participants (Y/N).
Diagnosed with aortic diseases: Aortic dissection, aortic aneurysms and/or thromboembolic aortic disease	Day 1	Percentage of participants (Y/N).
Diagnosed with CVD: Myocardial infarction, stable coronary artery disease (SCAD) also referred as angina (pectoris), other ischaemic heart disease and/or past revascularisation procedures	Day 1	Percentage of participants (Y/N).
Diagnosed with carotid artery disease	Day 1	Percentage of participants (Y/N).
Diagnosed with cardiac arrhythmia: Atrial fibrillation or flutter, ventricular tachycardia and/or ventricular fibrillation	Day 1	Percentage of participants (Y/N).
Diagnosed with cerebrovascular disease: Ischaemic stroke, haemorrhagic stroke, stroke (unspecified) and/or transient ischaemic attack	Day 1	Percentage of participants (Y/N).
Hospitalisation for heart failure	Day 1	Percentage of participants (Y/N).

Secondary Outcome Measures

Name	Time	Method
High risk of CVD (above 20% over 10 years) according to the risk engine from the United Kingdom Prospective Diabetes Study (UKPDS)	Day 1	Percentage of participants (Y/N).

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇮🇹 Savigliano (CN), Italy