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)

Novo Nordisk

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Other: No treatment given

Study type: Observational

Funder types: Industry

Identifiers

NCT03797885

NN2211-4435

U1111-1207-2878 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 730 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

730 participants in 2 patient groups

Patients with type 2 diabetes mellitus (T2DM)

Description:

Patients with type 2 diabetes, at the hospital setting.

Treatment:

Other: No treatment given

Patients with T2DM and established cardiovascular disease

Description:

Subgroup of patients with type 2 diabetes and established cardiovascular disease

Treatment:

Other: No treatment given