Clinical trial NCT03797885: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2019-01-09
Enrollment: 730
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with type 2 diabetes mellitus

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.


Eligibility criteria: 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

Primary outcomes:
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
timeFrame: Baseline (month 0)
Secondary outcomes:
measure: Hypoglycaemic episodes
timeFrame: During 3 years before baseline (0 to -36 months)
measure: Hyperglycaemic episodes
timeFrame: During 3 years before baseline (0 to -36 months)
measure: Presence of T2DM complications (yes/no)
timeFrame: During 3 years before baseline (0 to -36 months)
measure: Types of T2DM complications
timeFrame: During 3 years before baseline (0 to -36 months)
measure: Hospital appointments
timeFrame: During 3 years before baseline (0 to -36 months)
measure: Hospitalisation episodes
timeFrame: During 3 years before baseline (0 to -36 months)
measure: Emergency visits
timeFrame: During 3 years before baseline (0 to -36 months)
measure: Change in waist circumference
timeFrame: During 3 years before baseline (0 to -36 months)
measure: Change in body mass index
timeFrame: During 3 years before baseline (0 to -36 months)
measure: Change in blood pressure
timeFrame: During 3 years before baseline (0 to -36 months)
measure: Change in urine albumin
timeFrame: During 3 years before baseline (0 to -36 months)
measure: Change in urine albumin
timeFrame: During 3 years before baseline (0 to -36 months)
measure: Change in glycosylated hemoglobin (HbA1c)
timeFrame: During 3 years before baseline (0 to -36 months)
measure: Change in HbA1c
timeFrame: During 3 years before baseline (0 to -36 months)
measure: Change in Estimated Glomerular Filtration Rate (eGFR)
timeFrame: During 3 years before baseline (0 to -36 months)
measure: Change in total cholesterol
timeFrame: During 3 years before baseline (0 to -36 months)
measure: Change in low-density lipoprotein cholesterol
timeFrame: During 3 years before baseline (0 to -36 months)
measure: Change in high-density lipoprotein cholesterol
timeFrame: During 3 years before baseline (0 to -36 months)
measure: Change in triglyceride
timeFrame: During 3 years before baseline (0 to -36 months)
measure: Type of pharmacological treatment
timeFrame: During 3 years before baseline (0 to -36 months)
Other outcomes:
Locations:
city: Almada
country: Portugal
facility: Novo Nordisk Investigational Site
city: Caldas da Rainha
country: Portugal
facility: Novo Nordisk Investigational Site
city: Leiria
country: Portugal
facility: Novo Nordisk Investigational Site
city: Lisboa
country: Portugal
facility: Novo Nordisk Investigational Site
city: Lisboa
country: Portugal
facility: Novo Nordisk Investigational Site
city: Lisboa
country: Portugal
facility: Novo Nordisk Investigational Site
city: Matosinhos
country: Portugal
facility: Novo Nordisk Investigational Site
city: Portimão
country: Portugal
facility: Novo Nordisk Investigational Site
city: Porto
country: Portugal
facility: Novo Nordisk Investigational Site
city: Porto
country: Portugal
facility: Novo Nordisk Investigational Site
city: Viana do Castelo
country: Portugal
facility: Novo Nordisk Investigational Site
city: Vila Nova de Gaia
country: Portugal
facility: Novo Nordisk Investigational Site
city: Vila Real
country: Portugal
facility: Novo Nordisk Investigational Site
city: Viseu
country: Portugal
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor and Disclosure (1452)
role: STUDY_DIRECTOR
References: