NCT07390110Completed
Comparative Effectiveness of Oral Semaglutide vs Sitagliptin Among Individuals With Heart Failure With Preserved Ejection Fraction (STEP-HFpEF DM ORAL)
Source: ClinicalTrials.gov · Last updated 21 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 25664 (actual)
- First submitted
- 29 Jan 2026
- Start date
- 24 Jan 2026
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- Brigham and Women's Hospital
- Diseases
- Heart failure, Type 2 diabetes
- NCT number
- NCT07390110
What you commit to
- Study type: Observational
- Participants enrolled: 25664
- From 24 Jan 2026 to the primary completion date, 30 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Who the study is looking for
- Heart failure
- BMI \> 27.0kg/m2
- Type 2 diabetes mellitus
- LVEF \> 45%
- Age \> 18 years
- Sex: male or female
Criteria the registry did not label
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.