DelfaGLP-1 Atlas

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Active not recruiting

Comparative Effectiveness of Empagliflozin in the US

EMPagliflozin compaRative effectIveness and SafEty (EMPRISE) Study Program

Asset

GLP-1 / incretin class catch-all

Listed sites

1

Recruiting sites

—

Enrollment

230,000

actual

Study population

Type 2 diabetes

Key I/E criterion

—

Primary endpoints

•3-point MACE (Cardiovascular death, Non-fatal MI, Non-fatal stroke)•Heart-failure hospitalization•Expanded / custom MACE composite (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 IDNCT03363464
Org study ID1245.92

Timeline

Milestones

Study start2017-10-16actual
Study first posted2017-12-06actual
Last update posted2026-04-21actual
Primary completion2026-05-31estimated
Study completion2026-05-31estimated

Assets

Investigational agents

GLP-1 / incretin class catch-all

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted
Sampling methodNon probability sample

Study population text

T2DM eligible patients in Medicare fee for service, plans A, B, D; United Healthcare (Optum Clinformatics Data Mart); MarketScan (Truven Healthcare Analytics)

Inclusion criteria

•Patients >= 18 years old for Marketscan and Optum, and >=65 years old for Medicare only
•Patients initiating empagliflozin or a DPP-4 inhibitor within the study period. Initiation was defined as no use of SGLT-2 inhibitors (canagliflozin, dapagliflozin, ertugliflozin) or DPP-4 inhibitors in the previous 12 months.
•Restriction to patients with a diagnosis of T2DM (ICD-9 Dx code of 250.x0 or 250.x2; ICD-10 Dx code of E11.x) in the 12 months prior to drug initiation.

Exclusion criteria

•Patients with missing or ambiguous age or sex information.
•All patients who have less than 12 months of continuous registration in the database prior to initiation of empagliflozin or a DPP-4 inhibitor will be excluded.
•Patients with type 1 diabetes mellitus (T1DM) defined as at least 1 inpatient or outpatient codes in the 12 months prior to drug initiation.
•Secondary diabetes, and gestational diabetes in the 12 months prior to drug initiation
•History of cancer in the 5 years prior to drug initiation
•End-stage renal disease (ESRD) in the 12 months prior to drug initiation
•HIV diagnosis or treatment in the 12 months prior to drug initiation
•Organ transplant in the 12 months prior to drug initiation
•Patients that were in nursing homes in the 12 months prior to drug initiation
•Patients with concomitant SGLT-2 inhibitor and DPP-4 inhibitor initiation will also be excluded.
•Patients initiating more than one DPP-4i on cohort entry date will additionally be excluded Additional exclusion criteria apply.

Endpoints (18)

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
8
Safety / tolerability / PK
5
Renal / kidney
3
Heart failure
2

Cardiovascular outcomes

8 endpoints
Primary/protocol endpoint

3-point major adverse cardiovascular events (MACE)

Time frame:60 months

3-point MACE

time to event, event

componentsCardiovascular death, Non-fatal MI, Non-fatal stroke

Primary/protocol endpoint

Modified MACE

Time frame:60 months

Expanded / custom MACE composite

composite event, event

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

Primary/protocol endpoint

Composite of MI or stroke hospital admission for heart failure

Time frame:60 months

Expanded / custom MACE composite

composite event, event

componentsMyocardial infarction (any), Stroke (any), Heart-failure hospitalization

Primary/protocol endpoint

All-cause mortality

Time frame:60 months

All-cause death

time to event, event

SNOMED 419620001

Secondary/protocol endpoint

Coronary revascularization procedure

Time frame:60 months

Coronary revascularization

time to event, event

SNOMED 415070008

Secondary/protocol endpoint

Hospitalization for unstable angina

Time frame:60 months

Unstable angina hospitalization

time to event, event

Secondary/protocol endpoint

Composite of MI, stroke, unstable angina hospitalization or coronary revascularization

Time frame:60 months

Expanded / custom MACE composite

composite event, event

componentsMyocardial infarction (any), Stroke (any), Unstable angina hospitalization, Coronary revascularization

Secondary/protocol endpoint

Lower-limb amputation

Time frame:60 months

Major amputation

time to event, event

Heart failure

2 endpoints
Primary/protocol endpoint

Hospitalization for heart failure (specific, based on primary inpatient diagnosis code)

Time frame:60 months

Heart-failure hospitalization

time to event, event

SNOMED 84114007

Primary/protocol endpoint

Hospitalization for heart failure (broad, based on any inpatient diagnosis code)

Time frame:60 months

Heart-failure hospitalization

time to event, event

SNOMED 84114007

Renal / kidney

3 endpoints
Secondary/protocol endpoint

End-stage renal disease (ESRD)

Time frame:60 months

End-stage renal disease

time to event, event

SNOMED 46177005

Secondary/protocol endpoint

Acute kidney injury (Inpatient, primary)

Time frame:60 months

event count, event

Secondary/protocol endpoint

Acute kidney injury (Inpatient, any position)

Time frame:60 months

event count, event

Safety / tolerability / PK

5 endpoints
Secondary/protocol endpoint

Bone fracture

Time frame:60 months

descriptive, event

Secondary/protocol endpoint

Diabetic ketoacidosis (Inpatient, primary position)

Time frame:60 months

event count, event

Secondary/protocol endpoint

Diabetic ketoacidosis (Inpatient, any position)

Time frame:60 months

event count, event

Secondary/protocol endpoint

Severe hypoglycemia

Time frame:60 months

Severe hypoglycemia

event count, event

Secondary/protocol endpoint

Urinary tract cancers

Time frame:60 months

event count, event

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.