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Completed

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

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

Assets

Dulaglutide / Exenatide / GLP-1 / incretin class catch-all / Liraglutide / Lixisenatide

Listed sites

1

Recruiting sites

Enrollment

10,000

actual

Study population

Type 2 diabetes

Key I/E criterion

Primary endpoint

3-point MACE (Myocardial infarction (any), Stroke (any), All-cause death)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04184947
Org study IDDIMEDDEI3

Timeline

Milestones

Study start2014-03-01actual
Primary completion2018-12-31actual
Study first posted2019-12-04actual
Study completion2020-02-29actual
Last update posted2020-03-11actual

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age90 Years
SexAll
Sampling methodNon probability sample

Study population text

Type 2 diabetes

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.

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiovascular outcomes
6
Heart failure
1
Safety / tolerability / PK
1

Cardiovascular outcomes

6 endpoints
Primary/protocol endpoint

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

Time frame:3-26 months after index date

3-point MACE

time to event, event

componentsMyocardial infarction (any), Stroke (any), All-cause death

Secondary/protocol endpoint

Hospitalization for cardiovascular causes

Time frame:3-26 months after index date

time to event, event

Secondary/protocol endpoint

Death

Time frame:3-26 months after index date

All-cause death

time to event, event

SNOMED 419620001

Secondary/protocol endpoint

Myocardial infarction

Time frame:3-26 months after index date

Myocardial infarction (any)

time to event, event

SNOMED 22298006

Secondary/protocol endpoint/low confidence

Stroke

Time frame:3-26 months after index date

Stroke (any)

time to event, event

componentsStroke (any)

SNOMED 230690007

Secondary/protocol endpoint

Revascularization

Time frame:3-26 months after index date

CV events (total recurrent)

event count, event

componentsCoronary revascularization, Cerebrovascular revascularization, Peripheral revascularization

Heart failure

1 endpoint
Secondary/protocol endpoint

Heart failure

Time frame:3-26 months after index date

Heart-failure hospitalization

event count, event

SNOMED 84114007

Safety / tolerability / PK

1 endpoint
Other/protocol endpoint/low confidence

Occurrence of adverse events

Time frame:3-26 months after index date

Treatment-emergent AEs (any)

event count, event

componentsMajor amputation, Pancreatitis, Custom renal composite

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.