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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

NCT ID: NCT03797885

Last Updated: 2020-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

730 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-15

Study Completion Date

2019-10-15

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients with type 2 diabetes mellitus (T2DM)

Patients with type 2 diabetes, at the hospital setting.

No treatment given

Intervention Type OTHER

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

No treatment given

Intervention Type OTHER

No treatment is administered to the participants for this study

Interventions

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No treatment given

No treatment is administered to the participants for this study

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Reporting Anchor and Disclosure (1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Almada, , Portugal

Site Status

Novo Nordisk Investigational Site

Caldas da Rainha, , Portugal

Site Status

Novo Nordisk Investigational Site

Leiria, , Portugal

Site Status

Novo Nordisk Investigational Site

Lisbon, , Portugal

Site Status

Novo Nordisk Investigational Site

Lisbon, , Portugal

Site Status

Novo Nordisk Investigational Site

Lisbon, , Portugal

Site Status

Novo Nordisk Investigational Site

Matosinhos Municipality, , Portugal

Site Status

Novo Nordisk Investigational Site

Portimão, , Portugal

Site Status

Novo Nordisk Investigational Site

Porto, , Portugal

Site Status

Novo Nordisk Investigational Site

Porto, , Portugal

Site Status

Novo Nordisk Investigational Site

Viana do Castelo, , Portugal

Site Status

Novo Nordisk Investigational Site

Vila Nova de Gaia, , Portugal

Site Status

Novo Nordisk Investigational Site

Vila Real, , Portugal

Site Status

Novo Nordisk Investigational Site

Viseu, , Portugal

Site Status

Countries

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Portugal

Other Identifiers

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U1111-1207-2878

Identifier Type: OTHER

Identifier Source: secondary_id

NN2211-4435

Identifier Type: -

Identifier Source: org_study_id