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

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: GLP-1 receptor agonist; Drug: SGLT2 inhibitor

• Registration Number: NCT04184947
• Lead Sponsor: University of Padova

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-01
• Primary Completion: 2018-12-31
• Study First Submitted: 2019-12-01
• Study First Submitted QC: 2019-12-01
• Study First Posted: 2019-12-04
• Study Completion: 2020-02-29
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-08
• Last Update Posted: 2020-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GLP-1RA	GLP-1 receptor agonist	Patients who received new prescription of a GLP-1 receptor agonist
SGLT2i	SGLT2 inhibitor	Patients who received new prescription of a SGLT-2 inhibitor

Primary Outcome Measures

Name	Time	Method
3 point major adverse cardiovascular events (4P-MACE)	3-26 months after index date	First occurrence of myocardial infarction, stroke, or death

Secondary Outcome Measures

Name	Time	Method
Revascularization	3-26 months after index date	Any arterial site revascularization (surgical or endovascular)
Hospitalization for cardiovascular causes	3-26 months after index date	First hospitalization for any cardiovascular cause
Death	3-26 months after index date	All-cause death
Myocardial infarction	3-26 months after index date	Myocardial infarction
Heart failure	3-26 months after index date	Hospitalization for heart failure
Stroke	3-26 months after index date	Stroke or transient ischemic attack

Trial Locations

Locations (1)

Division of Metabolic Diseases, University Hospital of Padova; 🇮🇹 Padova, Italy