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

NCT04184947 | Completed

• 1 other identifier: DIMEDDEI3
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

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

  First occurrence of myocardial infarction, stroke, or death

  3-26 months after index date

Secondary Outcomes (6)

• Hospitalization for cardiovascular causes

  3-26 months after index date

• Death

  3-26 months after index date

• Myocardial infarction

  3-26 months after index date

• Heart failure

  3-26 months after index date

• Stroke

  3-26 months after index date

Other Outcomes (1)

• Occurrence of adverse events

  3-26 months after index date

Study Arms (2)

SGLT2i

Patients who received new prescription of a SGLT-2 inhibitor

Drug: SGLT2 inhibitor

GLP-1RA

Patients who received new prescription of a GLP-1 receptor agonist

Drug: GLP-1 receptor agonist

Interventions

SGLT2 inhibitor DRUG

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

SGLT2i

GLP-1 receptor agonist DRUG

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

GLP-1RA

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Type 2 diabetes

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

Division of Metabolic Diseases, University Hospital of Padova

Padua, 35128, Italy

Location

Related Publications (1)

• 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.

  PMID: 32591373 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sodium-Glucose Transporter 2 Inhibitors

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2019
• First Posted: December 4, 2019
• Study Start: March 1, 2014
• Primary Completion: December 31, 2018
• Study Completion: February 29, 2020
• Last Updated: March 11, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)