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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1207-2878 | Other Identifier | World Health Organization (WHO) |
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This study aims to estimate the number of patients with cardiovascular disease and risk factors in patients who had been diagnosed with type 2 diabetes mellitus. Simultaneously, this study also intends to obtain more information about the management of type 2 diabetes mellitus patients with established cardiovascular disease. This study is non-interventional, which means that will not require participant's further related visits or procedures. The study will collect the participant's clinical data from the current visit and, when applicable, within the last 3 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with type 2 diabetes mellitus (T2DM) | Patients with type 2 diabetes, at the hospital setting. |
| |
| Patients with T2DM and established cardiovascular disease | Subgroup of patients with type 2 diabetes and established cardiovascular disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No treatment given | Other | No treatment is administered to the participants for this study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of type 2 diabetes mellitus (T2DM) patients with cardiovascular risk factors (CVRFs) and/or established cardiovascular disease (CVD), regardless the date of diagnosis | Proportion of subjects. CVRFs are defined as a history of one or more of the following criteria:
CVD is defined as a history of one or more of the following events:
| Baseline (month 0) |
| Measure | Description | Time Frame |
|---|---|---|
| Hypoglycaemic episodes | Number of episodes | During 3 years before baseline (0 to -36 months) |
| Hyperglycaemic episodes | Number of episodes |
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Inclusion Criteria:
Main study population (Data collection - Prevalence):
Subgroup (Data collection - Patient management):
Exclusion Criteria:
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Patients with type 2 diabetes mellitus
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Reporting Anchor and Disclosure (1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Almada | 2805-267 | Portugal | |||
| Novo Nordisk Investigational Site |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| During 3 years before baseline (0 to -36 months) |
| Presence of T2DM complications (yes/no) | Number of patients for whom 'presence of T2DM complications' has been answered yes/no respectively | During 3 years before baseline (0 to -36 months) |
| Types of T2DM complications | Types of T2DM complications: Retinopathy, Diabetic neuropathy (peripheral, autonomic), Diabetic nephropathy, Amputation. | During 3 years before baseline (0 to -36 months) |
| Hospital appointments | Number of cardiology, ophthalmology, nephrology, and vascular surgery appointments | During 3 years before baseline (0 to -36 months) |
| Hospitalisation episodes | Number of episodes | During 3 years before baseline (0 to -36 months) |
| Emergency visits | Number of visits | During 3 years before baseline (0 to -36 months) |
| Change in waist circumference | Measured in cm | During 3 years before baseline (0 to -36 months) |
| Change in body mass index | Measured in kg/m^2 | During 3 years before baseline (0 to -36 months) |
| Change in blood pressure | Measured in mmHg | During 3 years before baseline (0 to -36 months) |
| Change in urine albumin | Measured in mg/24 hours | During 3 years before baseline (0 to -36 months) |
| Change in urine albumin | Measured in microgram/minute | During 3 years before baseline (0 to -36 months) |
| Change in glycosylated hemoglobin (HbA1c) | Measured in mmol/mol | During 3 years before baseline (0 to -36 months) |
| Change in HbA1c | Measured in % | During 3 years before baseline (0 to -36 months) |
| Change in Estimated Glomerular Filtration Rate (eGFR) | Measured in mL/min/1.73 m^2 | During 3 years before baseline (0 to -36 months) |
| Change in total cholesterol | measured in mg/dl | During 3 years before baseline (0 to -36 months) |
| Change in low-density lipoprotein cholesterol | measured in mg/dl | During 3 years before baseline (0 to -36 months) |
| Change in high-density lipoprotein cholesterol | measured in mg/dl | During 3 years before baseline (0 to -36 months) |
| Change in triglyceride | measured in mg/dl | During 3 years before baseline (0 to -36 months) |
| Type of pharmacological treatment | Types of pharmacological treatment: Antidiabetics Antihypertensive Lipid lowering therapy Antiplatelet/anticoagulant therapy | During 3 years before baseline (0 to -36 months) |
| Caldas da Rainha |
| 2500-176 |
| Portugal |
| Novo Nordisk Investigational Site | Leiria | 2410-197 | Portugal |
| Novo Nordisk Investigational Site | Lisbon | 1349-019 | Portugal |
| Novo Nordisk Investigational Site | Lisbon | 1500-650 | Portugal |
| Novo Nordisk Investigational Site | Lisbon | 1600-777 | Portugal |
| Novo Nordisk Investigational Site | Matosinhos Municipality | 4464-513 | Portugal |
| Novo Nordisk Investigational Site | Portimão | 8500-338 | Portugal |
| Novo Nordisk Investigational Site | Porto | 4099-001 | Portugal |
| Novo Nordisk Investigational Site | Porto | 4200-319 | Portugal |
| Novo Nordisk Investigational Site | Viana do Castelo | 4901-858 | Portugal |
| Novo Nordisk Investigational Site | Vila Nova de Gaia | 4434-502 | Portugal |
| Novo Nordisk Investigational Site | Vila Real | 5000-508 | Portugal |
| Novo Nordisk Investigational Site | Viseu | 3504-509 | Portugal |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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