An observational study in Type 2 Diabetes and Heart Failure, sponsored by Brigham and Women's Hospital. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-15.
Sponsored by Brigham and Women's Hospital · Observational
This cohort study aims to assess the comparative effectiveness of tirzepatide versus semaglutide with respect to cardiovascular events in patients with type 2 diabetes and heart failure with preserved ejection fraction.
Both semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1RA), and tirzepatide, a glucose-dependent insulinotropic polypeptide (GIP)/GLP-1RA, are currently approved treatments to control blood glucose in patients with type 2 diabetes (T2D) and to lower weight in patients with obesity, with or without T2D. Obesity is a leading risk factor for the onset and the progression of heart failure (HF), especially HF with preserved ejection fraction (HFpEF). Due to their potent weight-lowering action, semaglutide and tirzepatide have been recently evaluated in placebo-controlled trials conducted among persons with obesity and HFpEF, with or without T2D. These trials showed that semaglutide and tirzepatide reduced HF symptoms and HF events, compared to placebo.
In this new user, active comparator cohort study, the investigators will identify commercially insured adults (aged > 18 years) with T2D and HFpEF who initiated treatment with tirzepatide or semaglutide between June 1, 2022, and December 31, 2024. The investigators will retrieve information for each study participants using deidentified, longitudinal insurance claims data, including demographic characteristics, health plan enrollment status, inpatient and outpatient diagnoses, procedures, health care visits, hospitalizations, and pharmacy dispensing records.
Cohort entry is the day of initiation of tirzepatide or semaglutide. The follow-up starts on the day after cohort entry and continue until the occurrence of an outcome, discontinuation, switching, death, end of continuous health plan enrollment or end of the study period. Our primary outcome is a composite of hospitalization for HF or all-cause mortality.
The investigators will use propensity score adjustment to mitigate the risk of confounding. The investigators will calculate the number of events, incidence rates, and rate differences per 1000 person-years. Cox proportional hazard models will be used to estimate hazard ratios with their 95% confidence intervals.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's planned enrollment of 26,000 is above the median of 300 across 1,588 observational studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients > 18 years old with T2D and HFpEF.
Exclusion Criteria:
Patients who initiated tirzepatide with no use in the prior 180 days
Drug: Tirzepatide
Patients who initiate semaglutide with no use in the prior 180 days
Drug: Semaglutide
Exposure group
Referent group
Hospitalization for heart failure and all-cause mortality
Cardiovascular outcome includes hospitalization for HF and all-cause mortality
Time frame: From treatment initiation to end of follow up, up to 48 months.
This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Brigham and Women's Hospital