Diabetes Mellitus, Type 2 Clinical Trial
— EU-CAPTUREOfficial 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
| Verified date | June 2023 |
| Source | Novo Nordisk A/S |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | 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.
| Status | Completed |
| Enrollment | 2275 |
| Est. completion date | May 31, 2019 |
| Est. primary completion date | May 31, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 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 |
| Country | Name | City | State |
|---|---|---|---|
| Czechia | Novo Nordisk Investigational Site | Benatky nad Jizerou | |
| Czechia | Novo Nordisk Investigational Site | Boskovice | |
| Czechia | Novo Nordisk Investigational Site | Brandys nad Labem | |
| Czechia | Novo Nordisk Investigational Site | Breclav | |
| Czechia | Novo Nordisk Investigational Site | Chomutov | |
| Czechia | Novo Nordisk Investigational Site | Hradec Kralove | |
| Czechia | Novo Nordisk Investigational Site | Kromeriz | |
| Czechia | Novo Nordisk Investigational Site | Olomouc | |
| Czechia | Novo Nordisk Investigational Site | Orlova | |
| Czechia | Novo Nordisk Investigational Site | Ostrava | |
| Czechia | Novo Nordisk Investigational Site | Ostrava | |
| Czechia | Novo Nordisk Investigational Site | Plzen | |
| Czechia | Novo Nordisk Investigational Site | Praha | |
| France | Novo Nordisk Investigational Site | Chartres | |
| France | Novo Nordisk Investigational Site | Courpière | |
| France | Novo Nordisk Investigational Site | Le Creusot | |
| France | Novo Nordisk Investigational Site | Lyon | |
| France | Novo Nordisk Investigational Site | Montélimar | |
| France | Novo Nordisk Investigational Site | Saint Saens | |
| France | Novo Nordisk Investigational Site | Sathonay-Camp | |
| France | Novo Nordisk Investigational Site | Strasbourg | |
| France | Novo Nordisk Investigational Site | Tarare | |
| France | Novo Nordisk Investigational Site | Venissieux | |
| Italy | Novo Nordisk Investigational Site | Albano Laziale | |
| Italy | Novo Nordisk Investigational Site | Ariano Irpino | |
| Italy | Novo Nordisk Investigational Site | Bagno a Ripoli | |
| Italy | Novo Nordisk Investigational Site | Brindisi | |
| Italy | Novo Nordisk Investigational Site | Catanzaro | |
| Italy | Novo Nordisk Investigational Site | Fano | |
| Italy | Novo Nordisk Investigational Site | Ferrara | |
| Italy | Novo Nordisk Investigational Site | Firenze | |
| Italy | Novo Nordisk Investigational Site | Messina | |
| Italy | Novo Nordisk Investigational Site | Milano | |
| Italy | Novo Nordisk Investigational Site | Napoli | |
| Italy | Novo Nordisk Investigational Site | Negrar (VR) | |
| Italy | Novo Nordisk Investigational Site | Orvieto | |
| Italy | Novo Nordisk Investigational Site | Partinico (PA) | |
| Italy | Novo Nordisk Investigational Site | Ravenna | |
| Italy | Novo Nordisk Investigational Site | Roma | |
| Italy | Novo Nordisk Investigational Site | Rozzano (MI) | |
| Italy | Novo Nordisk Investigational Site | Savigliano (CN) |
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
Czechia, France, Italy,
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 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Diagnosed with cerebrovascular disease: Ischaemic stroke, haemorrhagic stroke, stroke (unspecified) and/or transient ischaemic attack | Percentage of participants (Y/N). | Day 1 | |
| Primary | 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). | Day 1 | |
| Primary | 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). | Day 1 | |
| Primary | Diagnosed with asymptomatic heart failure | Percentage of participants (Y/N). | Day 1 | |
| Primary | Hospitalisation for heart failure | Percentage of participants (Y/N). | Day 1 | |
| Primary | Diagnosed with cardiac arrhythmia: Atrial fibrillation or flutter, ventricular tachycardia and/or ventricular fibrillation | Percentage of participants (Y/N). | Day 1 | |
| Primary | Diagnosed with aortic diseases: Aortic dissection, aortic aneurysms and/or thromboembolic aortic disease | Percentage of participants (Y/N). | Day 1 | |
| Primary | 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). | Day 1 | |
| Primary | Diagnosed with carotid artery disease | Percentage of participants (Y/N). | Day 1 | |
| Secondary | 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). | Day 1 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT05666479 -
CGM Monitoring in T2DM Patients Undergoing Orthopaedic Replacement Surgery
|
||
| Completed |
NCT05647083 -
The Effect of Massage on Diabetic Parameters
|
N/A | |
| Active, not recruiting |
NCT05661799 -
Persistence of Physical Activity in People With Type 2 Diabetes Over Time.
|
N/A | |
| Completed |
NCT03686722 -
Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin
|
Phase 1 | |
| Completed |
NCT02836704 -
Comparison of Standard vs Higher Starting Dose of Insulin Glargine in Chinese Patients With Type 2 Diabetes (Glargine Starting Dose)
|
Phase 4 | |
| Completed |
NCT01819129 -
Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes
|
Phase 3 | |
| Completed |
NCT04562714 -
Impact of Flash Glucose Monitoring in People With Type 2 Diabetes Using Non-Insulin Antihyperglycemic Therapy
|
N/A | |
| Completed |
NCT02009488 -
Treatment Differences Between Canagliflozin and Placebo in Insulin Secretion in Subjects With Type 2 Diabetes Mellitus (T2DM)
|
Phase 1 | |
| Completed |
NCT05896319 -
Hyaluronic Acid Treatment of the Post-extraction Tooth Socket Healing in Subjects With Diabetes Mellitus Type 2
|
N/A | |
| Recruiting |
NCT05598203 -
Effect of Nutrition Education Groups in the Treatment of Patients With Type 2 Diabetes
|
N/A | |
| Completed |
NCT05046873 -
A Research Study Looking Into Blood Levels of Semaglutide and NNC0480-0389 When Given in the Same Injection or in Two Separate Injections in Healthy People
|
Phase 1 | |
| Terminated |
NCT04090242 -
Impact of App Based Diabetes Training Program in Conjunction With the BD Nano Pen Needle in People With T2 Diabetes
|
N/A | |
| Completed |
NCT04030091 -
Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus
|
Phase 4 | |
| Completed |
NCT03604224 -
A Study to Observe Clinical Effectiveness of Canagliflozin 300 mg Containing Treatment Regimens in Indian Type 2 Diabetes Participants With BMI>25 kg/m^2, in Real World Clinical Setting
|
||
| Completed |
NCT03620357 -
Continuous Glucose Monitoring & Management In Type 2 Diabetes (T2D)
|
N/A | |
| Completed |
NCT01696266 -
An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
|
||
| Completed |
NCT03620890 -
Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy
|
Phase 4 | |
| Withdrawn |
NCT05473286 -
A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Germany, as Part of Local Clinical Practice
|
||
| Not yet recruiting |
NCT05029804 -
Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes
|
N/A | |
| Completed |
NCT04531631 -
Effects of Dorzagliatin on 1st Phase Insulin and Beta-cell Glucose Sensitivity in T2D and Monogenic Diabetes
|
Phase 2 |