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

NCT07390110 · Sponsor: Brigham and Women's Hospital

What this trial means for you

This study is active, not recruiting — it is not currently taking new participants, but its results may matter for treatments you're considering. It's studying Oral semaglutide, Sitagliptin for type 2 diabetes, heart failure.

Who can joinAll sexes, 18 Years and older

Healthy volunteersNo — diagnosis required

What you'd takeOral semaglutide, Sitagliptin

Study length~4 months overall

Planned participants25,664

TypeObservational (no assigned treatment)

What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.

The study, in the sponsor's words

Investigators are building an empirical evidence base for real world data through large-scale emulation of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

Can you join? The exact criteria

Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.

Full eligibility criteria (for you and your doctor)

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

Study sites by state

Massachusetts

Brigham and Women's Hospital — Boston

View the official record on ClinicalTrials.gov →

Verify before you act. Medical disclaimer: content on this site is for informational purposes only and is not medical advice. GLP-1 medications are prescription drugs; always consult a licensed healthcare provider about eligibility, risks, and benefits. Trial details and enrollment status change frequently — always verify on the official registry and talk to your own clinician before contacting a study site. This page was generated from registry data and is not affiliated with the study sponsor.

Follow this trial

Get an email when our monthly digest covers enrollment changes and results for trials like this one.

Newsletter signup launches soon. (Site owner: set PUBLIC_BUTTONDOWN_USERNAME in .env to activate this form.)

Keep researching on StudyBackedHealth

Guides