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

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04184947
• Other study ID #: DIMEDDEI3
• Status: Completed
• Start date: March 1, 2014
• Est. completion date: February 29, 2020

Study information

• Verified date: March 2020
• Source: University of Padova
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10000
• Est. completion date: February 29, 2020
• Est. primary completion date: December 31, 2018
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Drug:
• SGLT2 inhibitor
New prescription of a SGLT-2 inhibitor (dapagliflozin, empagliflozin or canagliflozin) at any dosage during routine clinical practice
• GLP-1 receptor agonist
New prescription of a GLP-1 receptor agonisty (exenatide, liraglutide, lixisenatide, dulaglutide) at any dosage during routine clinical practice

Locations

Country	Name	City	State
Italy	Division of Metabolic Diseases, University Hospital of Padova	Padova

Sponsors (1)

Lead Sponsor	Collaborator
University of Padova

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Occurrence of adverse events	Occurrence of: amputation, Fournier's gangrene, bone fracture, diabetic ketoacidosis, infections, pancreatitis, pancreatic cancer, acute kidney injury	3-26 months after index date
Primary	3 point major adverse cardiovascular events (4P-MACE)	First occurrence of myocardial infarction, stroke, or death	3-26 months after index date
Secondary	Hospitalization for cardiovascular causes	First hospitalization for any cardiovascular cause	3-26 months after index date
Secondary	Death	All-cause death	3-26 months after index date
Secondary	Myocardial infarction	Myocardial infarction	3-26 months after index date
Secondary	Heart failure	Hospitalization for heart failure	3-26 months after index date
Secondary	Stroke	Stroke or transient ischemic attack	3-26 months after index date
Secondary	Revascularization	Any arterial site revascularization (surgical or endovascular)	3-26 months after index date