DelfaGLP-1 Atlas

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Completed

Cardiovascular Outcomes in Participants With Type 2 Diabetes Mellitus (T2DM)

Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus

Asset

GLP-1 / incretin class catch-all

Listed sites

1

Recruiting sites

—

Enrollment

25,358

actual

Study population

Cardiovascular disease, Type 2 diabetes

Key I/E criterion

•Established CVD

Primary endpoint

•Expanded / custom MACE composite (All-cause death, Heart-failure hospitalization)

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 IDNCT03249506
Org study IDCR108355
Secondary IDRRA-17640Janssen Research & Development, LLC

Timeline

Milestones

Study start2016-05-12actual
Study first posted2017-08-15actual
Primary completion2017-11-01actual
Study completion2017-11-01actual
Last update posted2017-11-21actual

Assets

Investigational agents

GLP-1 / incretin class catch-all

Study populations

Who this study enrolls

Cardiovascular diseaseType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted
Sampling methodNon probability sample

Study population text

Participants diagnosed with type 2 diabetes mellitus (T2DM) and established cardiovascular (CV) disease using the military health system (MHS) over a 3-year period (4/01/2013 to 3/31/2016) will be observed for the cardiovascular outcomes.

Inclusion criteria

•Type 2 diabetes mellitus (T2DM), defined as: greater than or equal to (>=) 1 anti-hyperglycemic agent (AHA) medication in the study period, and; >=1 diagnosis of T2DM in any available diagnosis field on or prior to index
•Established cardiovascular disease, defined as >=1 diagnosis in any diagnosis field for any of the following conditions: cerebrovascular disease; coronary artery disease (including heart failure [HF]); peripheral artery disease
•>=1-year pre-index continuous eligibility; enrollment gaps of less than or equal to (<=) 30 days will be considered continuous enrollment

Exclusion criteria

•Type 1 Diabetes mellitus (T1DM) diagnosis on or prior to the index date
•Secondary diabetes mellitus (DM) on or prior to the index date
•Missing sex data

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
7
Heart failure
1

Cardiovascular outcomes

7 endpoints
Primary/protocol endpoint

Incidence Rate of the Composite of All-cause Mortality (ACM) or Hospitalization for Heart Failure (HF)

Time frame:approximately 3 years

Expanded / custom MACE composite

composite event, event

componentsAll-cause death, Heart-failure hospitalization

Secondary/protocol endpoint

Incidence Rate of All-Cause Mortality

Time frame:approximately 3 years

All-cause death

event count, event

SNOMED 419620001

Secondary/protocol endpoint

Incidence Rate of Major Adverse Cardiovascular Events (MACE)

Time frame:approximately 3 years

Expanded / custom MACE composite

composite event, event

componentsAll-cause death, Non-fatal stroke, Non-fatal MI

Secondary/protocol endpoint

Incidence Rate of Composite of MACE or Hospitalization for HF

Time frame:approximately 3 years

Expanded / custom MACE composite

composite event, event

componentsAll-cause death, Non-fatal stroke, Non-fatal MI, Heart-failure hospitalization

Secondary/protocol endpoint

Incidence Rate of Non-fatal stroke

Time frame:approximately 3 years

Stroke (any)

event count, event

SNOMED 230690007

Secondary/protocol endpoint

Incidence Rate of Non-Fatal Myocardial Infarction

Time frame:approximately 3 years

Non-fatal MI

event count, event

SNOMED 22298006

Secondary/protocol endpoint

Percentage of Participants With Below Knee Lower Extremity (BKLE) Amputation

Time frame:approximately 3 years

Major amputation

threshold achievement, event

Heart failure

1 endpoint
Secondary/protocol endpoint

Incidence Rate of Hospitalization for HF

Time frame:approximately 3 years

Heart-failure hospitalization

event count, event

SNOMED 84114007

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.