NCT07390110

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25,664

participants targeted

Target at P75+ for all trials

Timeline
1mo left

Started Jan 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Jan 2026May 2026

Study Start

First participant enrolled

January 24, 2026

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 5, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2026

Last Updated

March 12, 2026

Status Verified

January 1, 2026

Enrollment Period

4 months

First QC Date

January 29, 2026

Last Update Submit

March 10, 2026

Conditions

Type 2 DiabetesHeart Failure

Outcome Measures

Primary Outcomes (2)

  • 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.

    To evaluate the comparative effect of oral semaglutide vs sitagliptin on the composite of worsening heart failure events or all-cause mortality in patients with heart failure with preserved ejection fraction in clinical practice.

    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.

  • Worsening heart failure event (exacerbated symptoms of heart failure resulting in hospitalization, intravenous diuretic therapy in an urgent care setting).

    To evaluate the comparative effect of oral semaglutide vs sitagliptin on worsening heart failure events with heart failure with preserved ejection fraction in clinical practice.

    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.

Secondary Outcomes (5)

  • Heart failure hospitalization.

    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.

  • Worsening heart failure event requiring intravenous diuretic therapy in an urgent care setting.

    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.

  • Urinary tract infections.

    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.

  • Serious infections.

    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.

  • Gastrointestinal adverse events.

    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.

Other Outcomes (2)

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

    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.

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

    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.

Study Arms (2)

Initiation of oral semaglutide

Exposure group: Semaglutide in the oral formulation in any dose.

Drug: Oral semaglutide

Initiation of sitagliptin

Reference group: Sitagliptin in the oral formulation in any dose

Drug: Sitagliptin

Interventions

Oral semaglutideDRUG

Initiation of semaglutide dispensing claim is used as the exposure.

Initiation of oral semaglutide
SitagliptinDRUG

Initiation of sitagliptin dispensing claim is used as the reference.

Initiation of sitagliptin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Heart Failure

Interventions

semaglutideSitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazines

Study Officials

  • Shirley Wang, PhD, ScM

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

  • Nils Krüger, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 29, 2026

First Posted

February 5, 2026

Study Start

January 24, 2026

Primary Completion (Estimated)

May 11, 2026

Study Completion (Estimated)

May 11, 2026

Last Updated

March 12, 2026

Record last verified: 2026-01

Locations

US(1)