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Diabetes Mellitus, Type 2PICT2RENCT03797885

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

An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 14 sites in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
No treatment given
How many people
730 participants
Where
14 sitesPortugal
Study dates
15 Jan 2019to 15 Oct 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with type 2 diabetes mellitus

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

Portugal14 sites

  • Novo Nordisk Investigational Site

    Almada, 2805-267

  • Novo Nordisk Investigational Site

    Caldas da Rainha, 2500-176

  • Novo Nordisk Investigational Site

    Leiria, 2410-197

  • Novo Nordisk Investigational Site

    Lisbon, 1349-019

  • Novo Nordisk Investigational Site

    Lisbon, 1500-650

  • Novo Nordisk Investigational Site

    Lisbon, 1600-777

  • Novo Nordisk Investigational Site

    Matosinhos Municipality, 4464-513

  • Novo Nordisk Investigational Site

    Portimão, 8500-338

  • Novo Nordisk Investigational Site

    Porto, 4099-001

  • Novo Nordisk Investigational Site

    Porto, 4200-319

  • Novo Nordisk Investigational Site

    Viana do Castelo, 4901-858

  • Novo Nordisk Investigational Site

    Vila Nova de Gaia, 4434-502

  • Novo Nordisk Investigational Site

    Vila Real, 5000-508

  • Novo Nordisk Investigational Site

    Viseu, 3504-509

Other trials in Portugal

About this study

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

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.

Being tested
No treatment given
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No treatment givenOther

    No treatment is administered to the participants for this study

Study groups in NCT03797885
Study groupRoleWhat they receive
Patients with type 2 diabetes mellitus (T2DM)Patients with type 2 diabetes, at the hospital setting.
Receives: Other: No treatment given
Patients with T2DM and established cardiovascular diseaseSubgroup of patients with type 2 diabetes and established cardiovascular disease
Receives: Other: No treatment given

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline (month 0)

Secondary outcomes (20)

  1. Hypoglycaemic episodes

    Number of episodes

    Measured: During 3 years before baseline (0 to -36 months)

  2. Hyperglycaemic episodes

    Number of episodes

    Measured: During 3 years before baseline (0 to -36 months)

  3. Presence of T2DM complications (yes/no)

    Number of patients for whom 'presence of T2DM complications' has been answered yes/no respectively

    Measured: During 3 years before baseline (0 to -36 months)

  4. Types of T2DM complications

    Types of T2DM complications: Retinopathy, Diabetic neuropathy (peripheral, autonomic), Diabetic nephropathy, Amputation.

    Measured: During 3 years before baseline (0 to -36 months)

  5. Hospital appointments

    Number of cardiology, ophthalmology, nephrology, and vascular surgery appointments

    Measured: During 3 years before baseline (0 to -36 months)

  6. Hospitalisation episodes

    Number of episodes

    Measured: During 3 years before baseline (0 to -36 months)

  7. Emergency visits

    Number of visits

    Measured: During 3 years before baseline (0 to -36 months)

  8. Change in waist circumference

    Measured in cm

    Measured: During 3 years before baseline (0 to -36 months)

  9. Change in body mass index

    Measured in kg/m^2

    Measured: During 3 years before baseline (0 to -36 months)

  10. Change in blood pressure

    Measured in mmHg

    Measured: During 3 years before baseline (0 to -36 months)

  11. Change in urine albumin

    Measured in mg/24 hours

    Measured: During 3 years before baseline (0 to -36 months)

  12. Change in urine albumin

    Measured in microgram/minute

    Measured: During 3 years before baseline (0 to -36 months)

  13. Change in glycosylated hemoglobin (HbA1c)

    Measured in mmol/mol

    Measured: During 3 years before baseline (0 to -36 months)

  14. Change in HbA1c

    Measured in %

    Measured: During 3 years before baseline (0 to -36 months)

  15. Change in Estimated Glomerular Filtration Rate (eGFR)

    Measured in mL/min/1.73 m^2

    Measured: During 3 years before baseline (0 to -36 months)

  16. Change in total cholesterol

    measured in mg/dl

    Measured: During 3 years before baseline (0 to -36 months)

  17. Change in low-density lipoprotein cholesterol

    measured in mg/dl

    Measured: During 3 years before baseline (0 to -36 months)

  18. Change in high-density lipoprotein cholesterol

    measured in mg/dl

    Measured: During 3 years before baseline (0 to -36 months)

  19. Change in triglyceride

    measured in mg/dl

    Measured: During 3 years before baseline (0 to -36 months)

  20. Type of pharmacological treatment

    Types of pharmacological treatment: Antidiabetics Antihypertensive Lipid lowering therapy Antiplatelet/anticoagulant therapy

    Measured: During 3 years before baseline (0 to -36 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2019
  2. Study start15 Jan 2019
  3. Primary completion15 Oct 2019
  4. Study completion15 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
730 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03797885
Sponsor's protocol ID
NN2211-4435
Other IDs
U1111-1207-2878
Acronym
PICT2RE
Status last verified
Nov 2020
First submitted
2 Jan 2019
Last updated
20 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 14 sites in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of type 2 diabetes mellitus (T2DM) patients with cardiovascular risk factors (CVRFs) and/or established cardiovascular disease (CVD), regardless the date of diagnosis (time frame: Baseline (month 0)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03797885.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2020.

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