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 (PICT2RE)

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Other: No treatment given

• Study Type: Observational
• Enrollment (Actual): 730

Contacts and Locations

Study Locations

• Portugal
  • Almada, Portugal, 2805-267
    • Novo Nordisk Investigational Site
  • Caldas da Rainha, Portugal, 2500-176
    • Novo Nordisk Investigational Site
  • Leiria, Portugal, 2410-197
    • Novo Nordisk Investigational Site
  • Lisboa, Portugal, 1500-650
    • Novo Nordisk Investigational Site
  • Lisboa, Portugal, 1349-019
    • Novo Nordisk Investigational Site
  • Lisboa, Portugal, 1600-777
    • Novo Nordisk Investigational Site
  • Matosinhos, Portugal, 4464-513
    • Novo Nordisk Investigational Site
  • Portimão, Portugal, 8500-338
    • Novo Nordisk Investigational Site
  • Porto, Portugal, 4200-319
    • Novo Nordisk Investigational Site
  • Porto, Portugal, 4099-001
    • Novo Nordisk Investigational Site
  • Viana do Castelo, Portugal, 4901-858
    • Novo Nordisk Investigational Site
  • Vila Nova de Gaia, Portugal, 4434-502
    • Novo Nordisk Investigational Site
  • Vila Real, Portugal, 5000-508
    • Novo Nordisk Investigational Site
  • Viseu, Portugal, 3504-509
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with type 2 diabetes mellitus

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with type 2 diabetes mellitus (T2DM); Patients with type 2 diabetes, at the hospital setting.	Other: No treatment given; No treatment is administered to the participants for this study
Patients with T2DM and established cardiovascular disease; Subgroup of patients with type 2 diabetes and established cardiovascular disease	Other: No treatment given; No treatment is administered to the participants for this study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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: 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypoglycaemic episodes	Number of episodes	During 3 years before baseline (0 to -36 months)
Hyperglycaemic episodes	Number of episodes	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)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2019
• Primary Completion (Actual): October 15, 2019
• Study Completion (Actual): October 15, 2019

Study Registration Dates

• First Submitted: January 2, 2019
• First Submitted That Met QC Criteria: January 8, 2019
• First Posted (Actual): January 9, 2019

Study Record Updates

• Last Update Posted (Actual): November 20, 2020
• Last Update Submitted That Met QC Criteria: November 19, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: NN2211-4435; U1111-1207-2878 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No