An observational study in Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 41 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-22.
Sponsored by Novo Nordisk A/S · Observational
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 2,275 is above the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study population will consist of male and female adults diagnosed with (type 2 diabetes mellitus (T2DM).
Exclusion Criteria:
All anti-diabetic and cardiovascular (CV) medication will be prescribed at the physician's discretion under routine clinical practice conditions.
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.
Diagnosed with cerebrovascular disease: Ischaemic stroke, haemorrhagic stroke, stroke (unspecified) and/or transient ischaemic attack
Percentage of participants (Y/N).
Time frame: Day 1
Diagnosed with CVD: Myocardial infarction, stable coronary artery disease (SCAD) also referred as angina (pectoris), other ischaemic heart disease and/or past revascularisation procedures
Percentage of participants (Y/N).
Time frame: Day 1
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)
Percentage of participants (Y/N).
Time frame: Day 1
Diagnosed with asymptomatic heart failure
Percentage of participants (Y/N).
Time frame: Day 1
Hospitalisation for heart failure
Percentage of participants (Y/N).
Time frame: Day 1
Diagnosed with cardiac arrhythmia: Atrial fibrillation or flutter, ventricular tachycardia and/or ventricular fibrillation
Percentage of participants (Y/N).
Time frame: Day 1
Diagnosed with aortic diseases: Aortic dissection, aortic aneurysms and/or thromboembolic aortic disease
Percentage of participants (Y/N).
Time frame: Day 1
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
Percentage of participants (Y/N).
Time frame: Day 1
Diagnosed with carotid artery disease
Percentage of participants (Y/N).
Time frame: Day 1
High risk of CVD (above 20% over 10 years) according to the risk engine from the United Kingdom Prospective Diabetes Study (UKPDS)
Percentage of participants (Y/N).
Time frame: Day 1
Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Novo Nordisk A/S