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

March 8, 2020 updated by: University of Padova

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Padova, Italy, 35128
        • Division of Metabolic Diseases, University Hospital of Padova

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Type 2 diabetes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
SGLT2i
Patients who received new prescription of a SGLT-2 inhibitor
Drug: SGLT2 inhibitor
New prescription of a SGLT-2 inhibitor (dapagliflozin, empagliflozin or canagliflozin) at any dosage during routine clinical practice
GLP-1RA
Patients who received new prescription of a GLP-1 receptor agonist
Drug: GLP-1 receptor agonist
New prescription of a GLP-1 receptor agonisty (exenatide, liraglutide, lixisenatide, dulaglutide) at any dosage during routine clinical practice

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
3 point major adverse cardiovascular events (4P-MACE)
Time Frame: 3-26 months after index date
First occurrence of myocardial infarction, stroke, or death
3-26 months after index date

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hospitalization for cardiovascular causes
Time Frame: 3-26 months after index date
First hospitalization for any cardiovascular cause
3-26 months after index date
Death
Time Frame: 3-26 months after index date
All-cause death
3-26 months after index date
Myocardial infarction
Time Frame: 3-26 months after index date
Myocardial infarction
3-26 months after index date
Heart failure
Time Frame: 3-26 months after index date
Hospitalization for heart failure
3-26 months after index date
Stroke
Time Frame: 3-26 months after index date
Stroke or transient ischemic attack
3-26 months after index date
Revascularization
Time Frame: 3-26 months after index date
Any arterial site revascularization (surgical or endovascular)
3-26 months after index date

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Occurrence of adverse events
Time Frame: 3-26 months after index date
Occurrence of: amputation, Fournier's gangrene, bone fracture, diabetic ketoacidosis, infections, pancreatitis, pancreatic cancer, acute kidney injury
3-26 months after index date

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Padova

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 29, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 1, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 4, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 11, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DIMEDDEI3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data cannot be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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