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Completed

NCT Number: NCT04184947

Cardiovascular Outcomes SGLT-2 Inhibitors Versus GLP-1 Receptor Agonists

Patients with type 2 diabetes (T2D) suffer from an excess risk of adverse cardiovascular events. Recently, two classes of glucose lowering agents, namely SGLT-2 inhibitors (SGLT2i) and GLP-1 receptor agonists (GLP-1RA), have proved superior to placebo in protecting T2D patients from cardiovascular events in dedicated trials. Patient populations in such trials were mainly composed of T2D individuals with established cardiovascular disease (CVD) or at very high risk for CVD. In addition, no clinical trial has so far compared cardiovascular outcomes of T2D associated with SGLT2i versus GLP-1RA. In addition, whether different results would incur in patients at lower CVD risk is unclear. On this basis, we designed this retrospective real-world study to compare cardiovascular outcomes of patients newly treated with SGLT2i versus GLP-1RA in routine clinical practice

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Division of Metabolic Diseases, University Hospital of Padova

Padova, 35128, Italy

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Italian citizens, residing in the Region
  • Registered as beneficiaries for at least one year between January 1st, 2012 and September 30th, 2018
  • Diagnosis of type 2 diabetes
  • Newly initiating SGLT-2 inhibitors or GLP-1 receptor agonists
  • Being treated with glucose lowering medications before (at least one prescription of an antidiabetic agent in ATC class A10B prior to the index date)
  • Time between the index date and the last SGLT2 inhibitors or GLP-1 receptor agonists prescription shorter than 8 months,
  • Follow-up time or time-to-endpoint of at least three months

Exclusion criteria

  • Patients who started SGLT2i or GLP-1RA before 2014
  • Patients with an insufficient exposure time
  • Patients with an incident event within three months after the index date.

Treatment and study plan

SGLT2 inhibitor

Drug

New prescription of a SGLT-2 inhibitor (dapagliflozin, empagliflozin or canagliflozin) at any dosage during routine clinical practice

GLP-1 receptor agonist

Drug

New prescription of a GLP-1 receptor agonisty (exenatide, liraglutide, lixisenatide, dulaglutide) at any dosage during routine clinical practice

Primary outcomes

  1. 3 point major adverse cardiovascular events (4P-MACE)

    Time frame: 3-26 months after index date

    First occurrence of myocardial infarction, stroke, or death

Secondary outcomes

  1. Hospitalization for cardiovascular causes

    Time frame: 3-26 months after index date

    First hospitalization for any cardiovascular cause

  2. Death

    Time frame: 3-26 months after index date

    All-cause death

  3. Myocardial infarction

    Time frame: 3-26 months after index date

    Myocardial infarction

  4. Heart failure

    Time frame: 3-26 months after index date

    Hospitalization for heart failure

  5. Stroke

    Time frame: 3-26 months after index date

    Stroke or transient ischemic attack

  6. Revascularization

    Time frame: 3-26 months after index date

    Any arterial site revascularization (surgical or endovascular)

Other outcomes

  1. Occurrence of adverse events

    Time frame: 3-26 months after index date

    Occurrence of: amputation, Fournier's gangrene, bone fracture, diabetic ketoacidosis, infections, pancreatitis, pancreatic cancer, acute kidney injury

Sponsors and collaborators

Lead sponsor

University of Padova

Other

Registry information

Official study title

Cardiovascular Outcomes of Type 2 Diabetic Patients Treated With SGLT-2 Inhibitors Versus GLP-1 Receptor Agonists in Real-life. An Observational Study Using Clinical-administrative Data

Important dates

Study start
2014
Primary completion
2018
Study completion
2020
First posted
Dec 4, 2019
Registry last updated
Mar 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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