NCT03797885|Completed

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

Novo Nordisk A/S ClinicalTrials.gov

Compare

2 other identifiers

NN2211-4435U1111-1207-2878

Study Type

observational

Target

730

Locations

1 country

Sites

Timeline

RegisteredJan 2019

StartedJan 2019

CompletionOct 2019

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

730

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach

1 country

14 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

9 months study duration

First Submitted

Initial submission to the registry

January 2, 2019

Completed

7 days until next milestone

First Posted

Study publicly available on registry

January 9, 2019

Completed

6 days until next milestone

Study Start

First participant enrolled

January 15, 2019

Completed

9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2019

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2019

Completed

Last Updated

November 20, 2020

Status Verified

November 1, 2020

Enrollment Period

9 months

First QC Date

January 2, 2019

Last Update Submit

November 19, 2020

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

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 Outcomes (20)

Hypoglycaemic episodes
During 3 years before baseline (0 to -36 months)
Hyperglycaemic episodes
During 3 years before baseline (0 to -36 months)
Presence of T2DM complications (yes/no)
During 3 years before baseline (0 to -36 months)
Types of T2DM complications
During 3 years before baseline (0 to -36 months)
Hospital appointments
During 3 years before baseline (0 to -36 months)
+15 more secondary outcomes

Study Arms (2)

Patients with type 2 diabetes mellitus (T2DM)

Patients with type 2 diabetes, at the hospital setting.

Other: No treatment given

Patients with T2DM and established cardiovascular disease

Subgroup of patients with type 2 diabetes and established cardiovascular disease

Other: No treatment given

Interventions

No treatment givenOTHER

No treatment is administered to the participants for this study

Patients with T2DM and established cardiovascular diseasePatients with type 2 diabetes mellitus (T2DM)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Patients with type 2 diabetes mellitus

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.