Clinical trial NCT04184947: Cardiovascular Outcomes SGLT-2 Inhibitors Versus GLP-1 Receptor Agonists
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2019-12-04
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 2 diabetes

Brief summary: 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


Eligibility criteria: 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.

Primary outcomes:
measure: 3 point major adverse cardiovascular events (4P-MACE)
timeFrame: 3-26 months after index date
Secondary outcomes:
measure: Hospitalization for cardiovascular causes
timeFrame: 3-26 months after index date
measure: Death
timeFrame: 3-26 months after index date
measure: Myocardial infarction
timeFrame: 3-26 months after index date
measure: Heart failure
timeFrame: 3-26 months after index date
measure: Stroke
timeFrame: 3-26 months after index date
measure: Revascularization
timeFrame: 3-26 months after index date
Other outcomes:
measure: Occurrence of adverse events
timeFrame: 3-26 months after index date
Locations:
city: Padova
country: Italy
facility: Division of Metabolic Diseases, University Hospital of Padova
Study officials:
References:
citation: Longato E, Di Camillo B, Sparacino G, Gubian L, Avogaro A, Fadini GP. Cardiovascular outcomes of type 2 diabetic patients treated with SGLT-2 inhibitors versus GLP-1 receptor agonists in real-life. BMJ Open Diabetes Res Care. 2020 Jun;8(1):e001451. doi: 10.1136/bmjdrc-2020-001451.