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

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Other: No treatment given

• Registration Number: NCT03797885
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-01-02
• Study First Submitted QC: 2019-01-08
• Study First Posted: 2019-01-09
• Study Start: 2019-01-15
• Primary Completion: 2019-10-15
• Study Completion: 2019-10-15
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-19
• Last Update Posted: 2020-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 730

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with type 2 diabetes mellitus (T2DM)	No treatment given	Patients with type 2 diabetes, at the hospital setting.
Patients with T2DM and established cardiovascular disease	No treatment given	Subgroup of patients with type 2 diabetes and established cardiovascular disease

Primary Outcome Measures

Name	Time	Method
Proportion of type 2 diabetes mellitus (T2DM) patients with cardiovascular risk factors (CVRFs) and/or established cardiovascular disease (CVD), regardless the date of diagnosis	Baseline (month 0)	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

Secondary Outcome Measures

Name	Time	Method
Change in total cholesterol	During 3 years before baseline (0 to -36 months)	measured in mg/dl
Hyperglycaemic episodes	During 3 years before baseline (0 to -36 months)	Number of episodes
Hospital appointments	During 3 years before baseline (0 to -36 months)	Number of cardiology, ophthalmology, nephrology, and vascular surgery appointments
Change in body mass index	During 3 years before baseline (0 to -36 months)	Measured in kg/m\^2
Change in urine albumin	During 3 years before baseline (0 to -36 months)	Measured in microgram/minute
Change in Estimated Glomerular Filtration Rate (eGFR)	During 3 years before baseline (0 to -36 months)	Measured in mL/min/1.73 m\^2
Change in high-density lipoprotein cholesterol	During 3 years before baseline (0 to -36 months)	measured in mg/dl
Type of pharmacological treatment	During 3 years before baseline (0 to -36 months)	Types of pharmacological treatment: Antidiabetics Antihypertensive Lipid lowering therapy Antiplatelet/anticoagulant therapy
Hypoglycaemic episodes	During 3 years before baseline (0 to -36 months)	Number of episodes
Change in blood pressure	During 3 years before baseline (0 to -36 months)	Measured in mmHg
Change in glycosylated hemoglobin (HbA1c)	During 3 years before baseline (0 to -36 months)	Measured in mmol/mol
Change in low-density lipoprotein cholesterol	During 3 years before baseline (0 to -36 months)	measured in mg/dl
Presence of T2DM complications (yes/no)	During 3 years before baseline (0 to -36 months)	Number of patients for whom 'presence of T2DM complications' has been answered yes/no respectively
Types of T2DM complications	During 3 years before baseline (0 to -36 months)	Types of T2DM complications: Retinopathy, Diabetic neuropathy (peripheral, autonomic), Diabetic nephropathy, Amputation.
Hospitalisation episodes	During 3 years before baseline (0 to -36 months)	Number of episodes
Emergency visits	During 3 years before baseline (0 to -36 months)	Number of visits
Change in waist circumference	During 3 years before baseline (0 to -36 months)	Measured in cm
Change in HbA1c	During 3 years before baseline (0 to -36 months)	Measured in %
Change in triglyceride	During 3 years before baseline (0 to -36 months)	measured in mg/dl

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇵🇹 Viseu, Portugal