Type 2 DiabetesNCT04184947
Cardiovascular Outcomes SGLT-2 Inhibitors Versus GLP-1 Receptor Agonists
An observational study of Type 2 Diabetes, run by University of Padova at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- SGLT2 inhibitor and GLP-1 receptor agonist
- How many people
- 10,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2014to 29 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Adult, Older adult
Study population: Type 2 diabetes
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Division of Metabolic Diseases, University Hospital of Padova
Padova, 35128
About this study
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
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
- Being tested
- SGLT2 inhibitor, GLP-1 receptor agonist
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGLT2 inhibitorDrug
New prescription of a SGLT-2 inhibitor (dapagliflozin, empagliflozin or canagliflozin) at any dosage during routine clinical practice
GLP-1 receptor agonistDrug
New prescription of a GLP-1 receptor agonisty (exenatide, liraglutide, lixisenatide, dulaglutide) at any dosage during routine clinical practice
| Study group | Role | What they receive |
|---|---|---|
| SGLT2i | Patients who received new prescription of a SGLT-2 inhibitor Receives: Drug: SGLT2 inhibitor | |
| GLP-1RA | Patients who received new prescription of a GLP-1 receptor agonist Receives: Drug: GLP-1 receptor agonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
3 point major adverse cardiovascular events (4P-MACE)
First occurrence of myocardial infarction, stroke, or death
Measured: 3-26 months after index date
Secondary outcomes (6)
Hospitalization for cardiovascular causes
First hospitalization for any cardiovascular cause
Measured: 3-26 months after index date
Death
All-cause death
Measured: 3-26 months after index date
Myocardial infarction
Myocardial infarction
Measured: 3-26 months after index date
Heart failure
Hospitalization for heart failure
Measured: 3-26 months after index date
Stroke
Stroke or transient ischemic attack
Measured: 3-26 months after index date
Revascularization
Any arterial site revascularization (surgical or endovascular)
Measured: 3-26 months after index date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start1 Mar 2014
- Primary completion31 Dec 2018
- Study completion29 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04184947
- Sponsor's protocol ID
- DIMEDDEI3
- Status last verified
- Mar 2020
- First submitted
- 1 Dec 2019
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data cannot be shared
Publications
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.
PubMed 32591373
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04184947
- Acronym / sponsor ID
- DIMEDDEI3
- Conditions
- Type 2 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,000 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 1 Mar 2014 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 29 Feb 2020 (actual)
- First posted
- 4 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SGLT2i | – | Drug: SGLT2 inhibitorPatients who received new prescription of a SGLT-2 inhibitor |
| GLP-1RA | – | Drug: GLP-1 receptor agonistPatients who received new prescription of a GLP-1 receptor agonist |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Type 2 diabetes
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SGLT2 inhibitorNew prescription of a SGLT-2 inhibitor (dapagliflozin, empagliflozin or canagliflozin) at any dosage during routine clinical practice | Drug | SGLT2i |
| GLP-1 receptor agonistNew prescription of a GLP-1 receptor agonisty (exenatide, liraglutide, lixisenatide, dulaglutide) at any dosage during routine clinical practice | Drug | GLP-1RA |
Primary outcome
3 point major adverse cardiovascular events (4P-MACE)
Time frame: 3-26 months after index date
First occurrence of myocardial infarction, stroke, or death
6 secondary outcomes
Hospitalization for cardiovascular causes
Time frame: 3-26 months after index date
Death
Time frame: 3-26 months after index date
Myocardial infarction
Time frame: 3-26 months after index date
Heart failure
Time frame: 3-26 months after index date
Stroke
Time frame: 3-26 months after index date
Revascularization
Time frame: 3-26 months after index date
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
- Derived from this study: PubMed 32591373Longato 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.
- Individual participant dataSharing planned: No. Data cannot be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by University of Padova at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3 point major adverse cardiovascular events (4P-MACE) (time frame: 3-26 months after index date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04184947, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2020.