A Study of People With Type 2 Diabetes Who Have Diseases That Affect the Heart and Blood Vessels. The Study Will Also Look at the Treatment of a Group of These People in Hospitals in Portugal

Diabetes Mellitus, Type 2 Clinical Trial

— PICT2RE  

Official title:

An Observational Cross-sectional Study to Estimate the Prevalence of Cardiovascular Disease and CV Risk Factors in T2DM Patients Including a Retrospective Phase to Evaluate the Clinical Management of a Subgroup of Patients in the Hospital Setting in Portugal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03797885
• Other study ID #: NN2211-4435
• Secondary ID: U1111-1207-2878
• Status: Completed
• Start date: January 15, 2019
• Est. completion date: October 15, 2019

Study information

• Verified date: November 2020
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 730
• Est. completion date: October 15, 2019
• Est. primary completion date: October 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Other:
• No treatment given
No treatment is administered to the participants for this study

Locations

Country	Name	City	State
Portugal	Novo Nordisk Investigational Site	Almada
Portugal	Novo Nordisk Investigational Site	Caldas da Rainha
Portugal	Novo Nordisk Investigational Site	Leiria
Portugal	Novo Nordisk Investigational Site	Lisboa
Portugal	Novo Nordisk Investigational Site	Lisboa
Portugal	Novo Nordisk Investigational Site	Lisboa
Portugal	Novo Nordisk Investigational Site	Matosinhos
Portugal	Novo Nordisk Investigational Site	Portimão
Portugal	Novo Nordisk Investigational Site	Porto
Portugal	Novo Nordisk Investigational Site	Porto
Portugal	Novo Nordisk Investigational Site	Viana do Castelo
Portugal	Novo Nordisk Investigational Site	Vila Nova de Gaia
Portugal	Novo Nordisk Investigational Site	Vila Real
Portugal	Novo Nordisk Investigational Site	Viseu

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: 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	Baseline (month 0)
Secondary	Hypoglycaemic episodes	Number of episodes	During 3 years before baseline (0 to -36 months)
Secondary	Hyperglycaemic episodes	Number of episodes	During 3 years before baseline (0 to -36 months)
Secondary	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)
Secondary	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)
Secondary	Hospital appointments	Number of cardiology, ophthalmology, nephrology, and vascular surgery appointments	During 3 years before baseline (0 to -36 months)
Secondary	Hospitalisation episodes	Number of episodes	During 3 years before baseline (0 to -36 months)
Secondary	Emergency visits	Number of visits	During 3 years before baseline (0 to -36 months)
Secondary	Change in waist circumference	Measured in cm	During 3 years before baseline (0 to -36 months)
Secondary	Change in body mass index	Measured in kg/m^2	During 3 years before baseline (0 to -36 months)
Secondary	Change in blood pressure	Measured in mmHg	During 3 years before baseline (0 to -36 months)
Secondary	Change in urine albumin	Measured in mg/24 hours	During 3 years before baseline (0 to -36 months)
Secondary	Change in urine albumin	Measured in microgram/minute	During 3 years before baseline (0 to -36 months)
Secondary	Change in glycosylated hemoglobin (HbA1c)	Measured in mmol/mol	During 3 years before baseline (0 to -36 months)
Secondary	Change in HbA1c	Measured in %	During 3 years before baseline (0 to -36 months)
Secondary	Change in Estimated Glomerular Filtration Rate (eGFR)	Measured in mL/min/1.73 m^2	During 3 years before baseline (0 to -36 months)
Secondary	Change in total cholesterol	measured in mg/dl	During 3 years before baseline (0 to -36 months)
Secondary	Change in low-density lipoprotein cholesterol	measured in mg/dl	During 3 years before baseline (0 to -36 months)
Secondary	Change in high-density lipoprotein cholesterol	measured in mg/dl	During 3 years before baseline (0 to -36 months)
Secondary	Change in triglyceride	measured in mg/dl	During 3 years before baseline (0 to -36 months)
Secondary	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)