DelfaGLP-1 Atlas

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Active not recruiting

Emulation of the REWIND Cardiovascular Outcomes Trial in Healthcare Claims Data.

Asset

Dulaglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

30,000

estimated

Study population

Type 2 diabetes

Key I/E criterion

•BMI ≥23

Primary endpoint

•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 IDNCT07417631
Org study ID2018P002966-REWIND

Timeline

Milestones

Study start2026-02-03actual
Study first posted2026-02-18actual
Last update posted2026-02-18actual
Primary completion2026-03estimated (month precision)
Study completion2026-03estimated (month precision)

Assets

Investigational agents

Dulaglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age50 Years
SexAll
Healthy volunteersNot accepted
Sampling methodNon probability sample

Study population text

Two populations: (1) Individuals with T2DM, who are either aged 50 years or above with an established cardiovascular disease, aged 55 years or above with a subclinical cardiovascular disease, or aged 60 years or above with at least two cardiovascular risk factors; and (2) individuals typically treated in clinical practice who are at low, moderate, and high cardiovascular risk with T2DM.

Inclusion criteria

Eligible Cohort Entry Dates:

The study will use three data sources: Optum Clinformatics, Merative MarketScan, and Medicare.

Optum: Eligible cohort entry period between September 18, 2014 to August 31, 2025.

MarketScan: Eligible cohort entry period between October 1, 2016 to October 31, 2023.

Medicare: Eligible cohort entry period between September 18, 2014 to October 31, 2020.

FOLLOWING ELIGIBILITY OF THE REWIND TRIAL:

Inclusion Criteria:

•MI, Stroke, Revascularization procedure, Diagnosis of coronary/carotid/peripheral artery disease, diagnosis of hypertensive heart disease
•BMI >= 23.0kg/m2
•Type 2 Diabetes Mellitus
•Chronic Kidney Disease (CKD) Stage 3/4
•Albuminuria
•Tobacco use
•Hypercholesterolemia/-lipidemia
•Stable dose of glucose-lowering drugs, use lipid-lowering drugs, use of blood pressure medication

Exclusion criteria

•MEN syndrome or medullary thyroid carcinoma, organ transplant, malignancy
•Severe hypoglycemic episode
•CKD stage 5 or dialysis
•Gastric emptying abnormality or bariatric surgery
•Pregnancy
•Craniocervical Instability (CCI)
•Pancreatitis
•Liver disease
•Weight loss drug
•Uncontrolled diabetes
•Acute coronary/cerebrovascular event
•Concurrent use of both study drugs

EXPANDED POPULATION:

Inclusion Criteria:

•History of MI, stroke, any surgical or percutaneous revascularization procedure, use of antihypertensive/ lipid-lowering drugs, coronary / carotid / peripheral artery disease
•BMI >= 25.0kg/m2
•Type 2 Diabetes

Exclusion Criteria:

•Medullary thyroid carcinoma,
•MEN syndrome type 2
•Malignancy
•Type 1 diabetes or secondary diabetes
•End-stage renal disease or dialysis
•Uncontrolled diabetic retinopathy or maculopathy
•Pregnancy
•Bariatric surgery
•Prior use of pramlintide or any GLP-1-RA except dulaglutide, or any DPP4i except sitagliptin

Endpoints (7)

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
4
Other clinical outcomes
2
Heart failure
1

Cardiovascular outcomes

4 endpoints
Primary/protocol endpoint

Composite of myocardial infarction, stroke, or all-cause mortality.

Time frame:Through study completion until the first of outcome, disenrollment, end of study period, discontinuation (45 days grace and risk window), switch between study arms, start of any other GLP-1-RA

Expanded / custom MACE composite

time to event, event

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

Primary/protocol endpoint

Myocardial infarction, stroke, or all-cause mortality

Time frame:Through study completion until the first of outcome, disenrollment, end of study period, discontinuation (45 days grace and risk window), switch between study arms, start of any other GLP-1-RA

Expanded / custom MACE composite

time to event, event

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

Secondary/protocol endpoint

The individual components of the primary end point, i.e., myocardial infarction, stroke, or all-cause mortality.

Time frame:Through study completion until the first of outcome, disenrollment, end of study period, discontinuation (45 days grace and risk window), switch between study arms, start of any other GLP-1-RA

time to event, event

Secondary/protocol endpoint

Unstable angina

Time frame:Through study completion until the first of outcome, disenrollment, end of study period, discontinuation (45 days grace and risk window), switch between study arms, start of any other GLP-1-RA

Unstable angina hospitalization

time to event, event

Heart failure

1 endpoint
Secondary/protocol endpoint

Heart failure events (exacerbated symptoms of heart failure resulting in hospitalization, or intravenous diuretic therapy in an urgent care setting).

Time frame:Through study completion until the first of outcome, disenrollment, end of study period, discontinuation (45 days grace and risk window), switch between study arms, start of any other GLP-1-RA

Heart-failure composite

composite event, event

componentsHeart-failure hospitalization, Urgent heart-failure visit

SNOMED 84114007

Other clinical outcomes

2 endpoints
Other/protocol endpoint

Hernia

Time frame:Through study completion until the first of outcome, disenrollment, end of study period, discontinuation (45 days grace and risk window), switch between study arms, start of any other GLP-1-RA

time to event, event

Other/protocol endpoint

Lumbar radiculopathy

Time frame:Through study completion until the first of outcome, disenrollment, end of study period, discontinuation (45 days grace and risk window), switch between study arms, start of any other GLP-1-RA

time to event, event

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.