DelfaGLP-1 Atlas

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Active not recruiting

Comparative Effectiveness of Oral Semaglutide vs Sitagliptin Among Individuals With Heart Failure With Preserved Ejection Fraction (STEP-HFpEF DM ORAL)

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

25,664

actual

Study population

Heart failure, Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI ≥27•EF ≥45%

Primary endpoints

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

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 IDNCT07390110
Org study ID2018P002966-STEP-HFpEF DM ORAL

Timeline

Milestones

Study start2026-01-24actual
Study first posted2026-02-05actual
Last update posted2026-05-28actual
Primary completion2026-05-30estimated
Study completion2026-05-30estimated

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Heart failureObesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted
Sampling methodNon probability sample

Study population text

Individuals aged 18 years or older with heart failure with preserved ejection fraction.

Inclusion criteria

Eligible Cohort Entry Dates:

•Optum: Eligible cohort entry period from September 20, 2019 to November 30, 2025.
•Marketscan: Eligible cohort entry from September 20, 2019 to December 31, 2023.
•Medicare: Eligible cohort entry from September 20, 2019 to December 31, 2020.

Inclusion Criteria:

•Heart failure
•BMI > 27.0kg/m2
•Type 2 diabetes mellitus
•LVEF > 45%
•Age > 18 years
•Sex: male or female

Exclusion criteria

•Multiple endocrine neoplasia type 2 or medullary thyroid carcinoma, other malignancy
•Type 1 diabetes mellitus, uncontrolled diabetic retinopathy or maculopathy, bariatric surgery, end-stage renal disease or dialysis, nursing home admission
•Any use of GLP-1-RA including injectable semaglutide except oral semaglutide, pregnancy, treatment with continuous subcutaneous insulin infusion
•Concurrent use of both study drugs

Endpoints (9)

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

Heart failure
3
Safety / tolerability / PK
3
Other clinical outcomes
2
Cardiovascular outcomes
1

Cardiovascular outcomes

1 endpoint
Primary/protocol endpoint

Composite of worsening heart failure event (exacerbated symptoms of heart failure resulting in hospitalization, intravenous diuretic therapy in an urgent care setting) 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 the arms, start of any other GLP-1-RA including injectable semaglutide.

Expanded / custom MACE composite

time to event, event

componentsHeart-failure hospitalization, All-cause death

Heart failure

3 endpoints
Primary/protocol endpoint

Worsening heart failure event (exacerbated symptoms of heart failure resulting in hospitalization, 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 the arms, start of any other GLP-1-RA including injectable semaglutide.

Heart-failure composite

time to event, event

componentsHeart-failure hospitalization, Urgent heart-failure visit

SNOMED 84114007

Secondary/protocol endpoint

Heart failure hospitalization.

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

Heart-failure hospitalization

time to event, event

SNOMED 84114007

Secondary/protocol endpoint

Worsening heart failure event requiring 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 the arms, start of any other GLP-1-RA including injectable semaglutide.

Urgent heart-failure visit

time to event, event

SNOMED 84114007

Safety / tolerability / PK

3 endpoints
Secondary/protocol endpoint

Urinary tract infections.

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

time to event, event

Secondary/protocol endpoint

Serious infections.

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

time to event, event

Secondary/protocol endpoint

Gastrointestinal adverse events.

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

descriptive, event

Other clinical outcomes

2 endpoints
Other/protocol endpoint

Hernia (excluding patients with recent outcome prior to the follow-up time window (30 days)).

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

time to event, event

Other/protocol endpoint

Lumbar radiculopathy (excluding patients with recent outcome prior to the follow-up time window (30 days)).

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

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.