Diabetes Mellitus, Type 2EU-CAPTURENCT03786406
An International Survey of the Occurrence of Diseases That Affects the Heart and Blood Vessels Among People With Type 2 Diabetes
An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 41 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- No treatment given
- How many people
- 2,275 participants
- Where
- 41 sitesin 3 countries
- Study dates
- 3 Dec 2018to 31 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of male and female adults diagnosed with (type 2 diabetes mellitus (T2DM).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
41 sites in 3 countries.
41 sites in 3 countries
Italy18 sites
Novo Nordisk Investigational Site
Albano Laziale, 00041
Novo Nordisk Investigational Site
Ariano Irpino, 83031
Novo Nordisk Investigational Site
Bagno a Ripoli, 50012
Novo Nordisk Investigational Site
Brindisi, 72100
Novo Nordisk Investigational Site
Catanzaro, 88100
Novo Nordisk Investigational Site
Fano, 61032
Novo Nordisk Investigational Site
Ferrara, 44123
Novo Nordisk Investigational Site
Florence, 50134
Novo Nordisk Investigational Site
Messina, 98128
Novo Nordisk Investigational Site
Milan, 20162
Novo Nordisk Investigational Site
Naples, 80121
Novo Nordisk Investigational Site
Negrar (VR), 37024
Novo Nordisk Investigational Site
Orvieto, 05018
Novo Nordisk Investigational Site
Partinico (PA), 90047
Novo Nordisk Investigational Site
Ravenna, 48121
Novo Nordisk Investigational Site
Roma, 00161
Novo Nordisk Investigational Site
Rozzano (MI), 20089
Novo Nordisk Investigational Site
Savigliano (CN), 12038
Czechia13 sites
Novo Nordisk Investigational Site
Benátky nad Jizerou, 29471
Novo Nordisk Investigational Site
Boskovice, 68001
Novo Nordisk Investigational Site
Brandýs nad Labem, 25001
Novo Nordisk Investigational Site
Břeclav, 69002
Novo Nordisk Investigational Site
Chomutov, 43004
Novo Nordisk Investigational Site
Hradec Králové, 50341
Novo Nordisk Investigational Site
Kroměříž, 76701
Novo Nordisk Investigational Site
Olomouc, 77900
Novo Nordisk Investigational Site
Orlová, 73514
Novo Nordisk Investigational Site
Ostrava, 70200
Novo Nordisk Investigational Site
Ostrava, 71800
Novo Nordisk Investigational Site
Pilsen, 30100
Novo Nordisk Investigational Site
Prague, 14000
France10 sites
Novo Nordisk Investigational Site
Chartres, 28000
Novo Nordisk Investigational Site
Courpière, 63120
Novo Nordisk Investigational Site
Le Creusot, 71200
Novo Nordisk Investigational Site
Lyon, 69007
Novo Nordisk Investigational Site
Montélimar, 26200
Novo Nordisk Investigational Site
Saint-Saëns, 76680
Novo Nordisk Investigational Site
Sathonay-Camp, 69580
Novo Nordisk Investigational Site
Strasbourg, 67000
Novo Nordisk Investigational Site
Tarare, 69170
Novo Nordisk Investigational Site
Vénissieux, 69200
About this study
Official title: A Non-interventional Cross-sectional Study to Capture the Prevalence of Cardiovascular Disease in Patients With Type 2 Diabetes in Selected Countries in Europe
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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- No treatment given
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No treatment givenOther
No specific intervention is studied. All anti-diabetic and CV medication will be prescribed at the physician's discretion under routine clinical practice conditions.
| Study group | Role | What they receive |
|---|---|---|
| T2DM patients seen in routine practice | All anti-diabetic and cardiovascular (CV) medication will be prescribed at the physician's discretion under routine clinical practice conditions. Receives: Other: No treatment given |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosed with cerebrovascular disease: Ischaemic stroke, haemorrhagic stroke, stroke (unspecified) and/or transient ischaemic attack
Percentage of participants (Y/N).
Measured: 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).
Measured: 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).
Measured: Day 1
Diagnosed with asymptomatic heart failure
Percentage of participants (Y/N).
Measured: Day 1
Hospitalisation for heart failure
Percentage of participants (Y/N).
Measured: Day 1
Diagnosed with cardiac arrhythmia: Atrial fibrillation or flutter, ventricular tachycardia and/or ventricular fibrillation
Percentage of participants (Y/N).
Measured: Day 1
Diagnosed with aortic diseases: Aortic dissection, aortic aneurysms and/or thromboembolic aortic disease
Percentage of participants (Y/N).
Measured: 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).
Measured: Day 1
Diagnosed with carotid artery disease
Percentage of participants (Y/N).
Measured: Day 1
Secondary outcomes (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).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start3 Dec 2018
- Primary completion31 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 2,275 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Reporting Anchor and Disclosure (1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03786406
- Sponsor's protocol ID
- NN2211-4423
- Other IDs
- U1111-1207-2816
- Acronym
- EU-CAPTURE
- Status last verified
- Jun 2023
- First submitted
- 20 Dec 2018
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Publications
Mosenzon O, Alguwaihes A, Leon JLA, Bayram F, Darmon P, Davis TME, Dieuzeide G, Eriksen KT, Hong T, Kaltoft MS, Lengyel C, Rhee NA, Russo GT, Shirabe S, Urbancova K, Vencio S; CAPTURE Study Investigators. CAPTURE: a multinational, cross-sectional study of cardiovascular disease prevalence in adults with type 2 diabetes across 13 countries. Cardiovasc Diabetol. 2021 Jul 27;20(1):154. doi: 10.1186/s12933-021-01344-0.
PubMed 34315481Vencio S, Vianna AGD, da Silva MACF, Precoma DB. Contemporary (2019) prevalence of cardiovascular disease in adults with type 2 diabetes in Brazil: the cross-sectional CAPTURE study. Diabetol Metab Syndr. 2022 Jan 10;14(1):5. doi: 10.1186/s13098-021-00775-9.
PubMed 35012646
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional Cross-sectional Study to Capture the Prevalence of Cardiovascular Disease in Patients With Type 2 Diabetes in Selected Countries in Europe
- ClinicalTrials.gov ID
- NCT03786406
- Acronym / sponsor ID
- EU-CAPTURE / NN2211-4423
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,275 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 3 Dec 2018 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 26 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| T2DM patients seen in routine practice | – | Other: No treatment givenAll anti-diabetic and cardiovascular (CV) medication will be prescribed at the physician's discretion under routine clinical practice conditions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of male and female adults diagnosed with (type 2 diabetes mellitus (T2DM).
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No treatment givenNo specific intervention is studied. All anti-diabetic and CV medication will be prescribed at the physician's discretion under routine clinical practice conditions. | Other | T2DM patients seen in routine practice |
Primary outcome
Diagnosed with cerebrovascular disease: Ischaemic stroke, haemorrhagic stroke, stroke (unspecified) and/or transient ischaemic attack
Time frame: 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
Time frame: 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)
Time frame: Day 1
Percentage of participants (Y/N).
Diagnosed with asymptomatic heart failure
Time frame: Day 1
Percentage of participants (Y/N).
Hospitalisation for heart failure
Time frame: Day 1
Percentage of participants (Y/N).
Diagnosed with cardiac arrhythmia: Atrial fibrillation or flutter, ventricular tachycardia and/or ventricular fibrillation
Time frame: Day 1
Percentage of participants (Y/N).
Diagnosed with aortic diseases: Aortic dissection, aortic aneurysms and/or thromboembolic aortic disease
Time frame: Day 1
Percentage of participants (Y/N).
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
Time frame: Day 1
Percentage of participants (Y/N).
Diagnosed with carotid artery disease
Time frame: Day 1
Percentage of participants (Y/N).
1 secondary outcome
High risk of CVD (above 20% over 10 years) according to the risk engine from the United Kingdom Prospective Diabetes Study (UKPDS)
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Results publication: PubMed 34315481Mosenzon O, Alguwaihes A, Leon JLA, Bayram F, Darmon P, Davis TME, Dieuzeide G, Eriksen KT, Hong T, Kaltoft MS, Lengyel C, Rhee NA, Russo GT, Shirabe S, Urbancova K, Vencio S; CAPTURE Study Investigators. CAPTURE: a multinational, cross-sectional study of cardiovascular disease prevalence in adults with type 2 diabetes across 13 countries. Cardiovasc Diabetol. 2021 Jul 27;20(1):154. doi: 10.1186/s12933-021-01344-0.
- Derived from this study: PubMed 35012646Vencio S, Vianna AGD, da Silva MACF, Precoma DB. Contemporary (2019) prevalence of cardiovascular disease in adults with type 2 diabetes in Brazil: the cross-sectional CAPTURE study. Diabetol Metab Syndr. 2022 Jan 10;14(1):5. doi: 10.1186/s13098-021-00775-9.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Related trials for Diabetes Mellitus, Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Reporting Anchor and Disclosure (1452) study director
Novo Nordisk A/S
41 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 41 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in Italy, Czechia, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosed with cerebrovascular disease: Ischaemic stroke, haemorrhagic stroke, stroke (unspecified) and/or transient ischaemic attack (time frame: Day 1). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03786406, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.