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

U

University of Padova

Status

Completed

Conditions

Type 2 Diabetes

Treatments

Drug: GLP-1 receptor agonist
Drug: SGLT2 inhibitor

Study type

Observational

Funder types

Other

Identifiers

NCT04184947
DIMEDDEI3

Details and patient eligibility

About

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

Enrollment

10,000 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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.

Trial design

10,000 participants in 2 patient groups

SGLT2i
Description:
Patients who received new prescription of a SGLT-2 inhibitor
Treatment:
Drug: SGLT2 inhibitor
GLP-1RA
Description:
Patients who received new prescription of a GLP-1 receptor agonist
Treatment:
Drug: GLP-1 receptor agonist

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems