Diabetes Mellitus, Type 2
Conditions
Brief summary
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.
Interventions
OTHERNo treatment given
No treatment is administered to the participants for this study
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Main study population (Data collection - Prevalence): * Signed Informed Consent Form (ICF) obtained before any study-related activities (study-related activities are any procedures related to recording of data according to protocol) * Male or female patient, age greater or equal to 18 years at the time of signing ICF * Patients diagnosed with type 2 diabetes Subgroup (Data collection - Patient management): * Patients followed at the hospital setting by the endocrinologist or internal medicine specialist (ambulatory diabetes management) and with available medical records, retrospectively within the last three years * Patients with type 2 diabetes mellitus and established cardiovascular disease diagnosed at least three years ago
Exclusion criteria
* Previous participation in this study. Participation is defined as signed ICF * Female patient who is pregnant or breast-feeding * Patients with type 1 diabetes * Participation in a clinical trial within the last 3 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of type 2 diabetes mellitus (T2DM) patients with cardiovascular risk factors (CVRFs) and/or established cardiovascular disease (CVD), regardless the date of diagnosis | Baseline (month 0) | Proportion of subjects. CVRFs are defined as a history of one or more of the following criteria: * Overweight or obese * Family history of CVD (1st degree) * Hypertension * Hypercholesterolemia * Low high-density lipoproteins * Hypertriglyceridemia * Smoking habits * Sedentary lifestyle -as per Investigator discretion according to his/her normal practice. CVD is defined as a history of one or more of the following events: * Stroke * Transient ischaemic attack * Ischaemic heart disease including myocardial infarction * Congestive heart failure * Atrial fibrillation * Aortic aneurism * Peripheral or carotid artery disease |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hyperglycaemic episodes | During 3 years before baseline (0 to -36 months) | Number of episodes |
| Presence of T2DM complications (yes/no) | During 3 years before baseline (0 to -36 months) | Number of patients for whom 'presence of T2DM complications' has been answered yes/no respectively |
| Types of T2DM complications | During 3 years before baseline (0 to -36 months) | Types of T2DM complications: Retinopathy, Diabetic neuropathy (peripheral, autonomic), Diabetic nephropathy, Amputation. |
| Hospital appointments | During 3 years before baseline (0 to -36 months) | Number of cardiology, ophthalmology, nephrology, and vascular surgery appointments |
| Hospitalisation episodes | During 3 years before baseline (0 to -36 months) | Number of episodes |
| Emergency visits | During 3 years before baseline (0 to -36 months) | Number of visits |
| Change in waist circumference | During 3 years before baseline (0 to -36 months) | Measured in cm |
| Change in body mass index | During 3 years before baseline (0 to -36 months) | Measured in kg/m\^2 |
| Change in blood pressure | During 3 years before baseline (0 to -36 months) | Measured in mmHg |
| Hypoglycaemic episodes | During 3 years before baseline (0 to -36 months) | Number of episodes |
| Change in glycosylated hemoglobin (HbA1c) | During 3 years before baseline (0 to -36 months) | Measured in mmol/mol |
| Change in HbA1c | During 3 years before baseline (0 to -36 months) | Measured in % |
| Change in Estimated Glomerular Filtration Rate (eGFR) | During 3 years before baseline (0 to -36 months) | Measured in mL/min/1.73 m\^2 |
| Change in total cholesterol | During 3 years before baseline (0 to -36 months) | measured in mg/dl |
| Change in low-density lipoprotein cholesterol | During 3 years before baseline (0 to -36 months) | measured in mg/dl |
| Change in high-density lipoprotein cholesterol | During 3 years before baseline (0 to -36 months) | measured in mg/dl |
| Change in triglyceride | During 3 years before baseline (0 to -36 months) | measured in mg/dl |
| Type of pharmacological treatment | During 3 years before baseline (0 to -36 months) | Types of pharmacological treatment: Antidiabetics Antihypertensive Lipid lowering therapy Antiplatelet/anticoagulant therapy |
| Change in urine albumin | During 3 years before baseline (0 to -36 months) | Measured in mg/24 hours |
Countries
Portugal
Outcome results
None listed