Type 2 DiabetesDUP-SURPASSNCT07088718
Prediction of the SURPASS-CVOT Cardiovascular Outcome Trial in Healthcare Claims Data
An observational study of Type 2 Diabetes and Major Adverse Cardiac Events, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Type 2 Diabetes, Major Adverse Cardiac Events, Cardiovascular (CV) Risk
- What is being tested?
- Tirzepatide and Dulaglutide
- How many people
- 44,671 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to 30 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals aged 40 years or older with T2DM and an established CVD
Who may be able to join
- History of MI, surgical or percutaneous coronary/carotid peripheral artery revascularization
- BMI ≥25.0kg/m2
- Type 2 diabetes, diagnosis of coronary/carotid/peripheral artery disease
- Age ≥40 years
- Male or female sex
Who cannot join
- Medullary thyroid carcinoma, MEN syndrome type 2, malignancy
- Treatment for diabetic retinopathy//macular edema, pancreatitis, gastric emptying abnormality/bariatric surgery, liver disease, end-stage renal disease or dialysis, pregnancy
- Prior use of pramlintide or any GLP-1-RA except tirzepatide or dulaglutide
- Cardiovascular event, hospitalization for heart failure
- Concurrent use of both drugs i.e. tirzepatide and dulaglutide
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02120
About this study
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.
Read the detailed description
This is a non-randomized, non-interventional study that is part of the Randomized Controlled Trials Duplicated Using Prospective Longitudinal Insurance Claims: Applying Techniques of Epidemiology (RCT-DUPLICATE) initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to emulate, as closely as is possible in healthcare insurance claims data, the SURPASS-CVOT trial described below. Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. Randomization cannot be achieved in healthcare claims data but was proxied through a statistical balancing of measured covariates according to standard practice. Investigators assume that the RCT provides guidance on the reference standard treatment effect estimate. However, failure to replicate RCT findings is not necessarily indicative of the inadequacy of the healthcare claims data for emulation for a range of possible reasons and does not provide information on the validity of the original RCT finding.
The SURPASS-CVOT trial is a non-inferiority trial that aims to evaluate the effect of tirzepatide, a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 receptor agonist (GLP-1-RA), vs dulaglutide, a GLP-1-RA, on time to first occurrence of any major adverse cardiovascular event (MACE), defined as cardiovascular death, myocardial infarction, or stroke among patients with type 2 diabetes mellitus (T2DM) and an established cardiovascular disease (CVD). In addition, the trial aims to determine noninferiority with a magnitude of difference that also supports superiority against putative placebo and for superiority to dulaglutide will be performed. With estimated study completion in summer 2025, results of the trial are yet to be announced. Therefore, we aim to predict the results of the SURPASS-CVOT trial by emulating its design with protocol registration and statistical analysis conducted before the results of the trial are made public.
The database study designed to emulate the SURPASS-CVOT trial will be a new-user active-comparative study, conducted using 2 national United States claims databases, where we compare the effect of tirzepatide vs dulaglutide on the composite end point of all-cause mortality, myocardial infarction, or stroke. Clinical guidelines during the study period recommended both agents under investigation as second-line options for glucose lowering and were similarly costly.
- Being tested
- Tirzepatide, Dulaglutide
- Medical subject headings
- Diabetes Mellitus, Type 2, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
New use of tirzepatide dispensing claim is used as the exposure.
DulaglutideDrug
New use of dulaglutide dispensing claim is used as the reference.
| Study group | Role | What they receive |
|---|---|---|
| Tirzepatide | Exposure group Receives: Drug: Tirzepatide | |
| Dulaglutide | Reference group Receives: Drug: Dulaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
First occurence of MACE (all-cause mortailty, myocardial infarction, or death)
To evaluate the comparative effect of tirzepatide vs dulaglutide on time to first occurrence of MACE (all-cause mortailty, myocardial infarction, or death) in patients with T2DM and an established CVD when following the eligibility criteria of the SURPASS-CVOT trial: Individuals aged 40 years or older with T2DM and an established CVD.
Measured: 1 day after cohort entry date until the first of outcome or censoring, up to 365 days
Secondary outcomes (3)
Individual components of the primary endpoint, i.e., all-cause mortality, myocardial infarction, or stroke (Tirzepatide vs dulaglutide)
To evaluate the comparative effect of tirzepatide vs dulaglutide on the individual components of the primary endpoint, i.e., all-cause mortality, myocardial infarction, or stroke in patients with T2DM and an established CVD when following the eligibility criteria of the SURPASS-CVOT trial: Individuals aged 40 years or older with T2DM and an established CVD.
Measured: 1 day after cohort entry date until the first of outcome or censoring, up to 365 days
Hernia
To evaluate the effect of tirzepatide vs dulaglutide on a negative control outcome of hernia in patients with T2DM and an established CVD when following the eligibility criteria of the SURPASS-CVOT trial: Individuals aged 40 years or older with T2DM and an established CVD.
Measured: 1 day after cohort entry date until the first of outcome or censoring, up to 365 days
Lumbar radiculopathy
To evaluate the effect of tirzepatide vs dulaglutide on a negative control outcome of lumbar radiculopathy in patients with T2DM and an established CVD when following the eligibility criteria of the SURPASS-CVOT trial: Individuals aged 40 years or older with T2DM and an established CVD.
Measured: 1 day after cohort entry date until the first of outcome or censoring, up to 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start1 Oct 2024
- Primary completion30 Jul 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 44,671 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shirley Vichy Wang, Brigham and Women's Hospital
- Investigators
- Shirley Wang, PhD, ScM, Principal investigator, Brigham and Women's HospitalNils Krüger, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07088718
- Sponsor's protocol ID
- 2018P002966-DUP-SURPASSCVOT
- Acronym
- DUP-SURPASS
- Status last verified
- Aug 2025
- First submitted
- 19 Jul 2025
- Last updated
- 15 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Kruger N, Schneeweiss S, Desai RJ, Sreedhara SK, Kehoe AR, Fuse K, Hahn G, Schunkert H, Wang SV. Cardiovascular outcomes of semaglutide and tirzepatide for patients with type 2 diabetes in clinical practice. Nat Med. 2026 Jan;32(1):342-352. doi: 10.1038/s41591-025-04102-x. Epub 2025 Nov 9.
PubMed 41207920
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of the SURPASS-CVOT Cardiovascular Outcome Trial in Healthcare Claims Data
- ClinicalTrials.gov ID
- NCT07088718
- Acronym / sponsor ID
- DUP-SURPASS / 2018P002966-DUP-SURPASSCVOT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44,671 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 28 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a non-randomized, non-interventional study that is part of the Randomized Controlled Trials Duplicated Using Prospective Longitudinal Insurance Claims: Applying Techniques of Epidemiology (RCT-DUPLICATE) initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to emulate, as closely as is possible in healthcare insurance claims data, the SURPASS-CVOT trial described below. Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. Randomization cannot be achieved in healthcare claims data but was proxied through a statistical balancing of measured covariates according to standard practice. Investigators assume that the RCT provides guidance on the reference standard treatment effect estimate. However, failure to replicate RCT findings is not necessarily indicative of the inadequacy of the healthcare claims data for emulation for a range of possible reasons and does not provide information on the validity of the original RCT finding.
The SURPASS-CVOT trial is a non-inferiority trial that aims to evaluate the effect of tirzepatide, a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 receptor agonist (GLP-1-RA), vs dulaglutide, a GLP-1-RA, on time to first occurrence of any major adverse cardiovascular event (MACE), defined as cardiovascular death, myocardial infarction, or stroke among patients with type 2 diabetes mellitus (T2DM) and an established cardiovascular disease (CVD). In addition, the trial aims to determine noninferiority with a magnitude of difference that also supports superiority against putative placebo and for superiority to dulaglutide will be performed. With estimated study completion in summer 2025, results of the trial are yet to be announced. Therefore, we aim to predict the results of the SURPASS-CVOT trial by emulating its design with protocol registration and statistical analysis conducted before the results of the trial are made public.
The database study designed to emulate the SURPASS-CVOT trial will be a new-user active-comparative study, conducted using 2 national United States claims databases, where we compare the effect of tirzepatide vs dulaglutide on the composite end point of all-cause mortality, myocardial infarction, or stroke. Clinical guidelines during the study period recommended both agents under investigation as second-line options for glucose lowering and were similarly costly.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tirzepatide | – | Drug: TirzepatideExposure group |
| Dulaglutide | – | Drug: DulaglutideReference group |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals aged 40 years or older with T2DM and an established CVD
Key inclusion criteria (5 listed)
- History of MI, surgical or percutaneous coronary/carotid peripheral artery revascularization
- BMI ≥25.0kg/m2
- Type 2 diabetes, diagnosis of coronary/carotid/peripheral artery disease
- Age ≥40 years
- Male or female sex
Key exclusion criteria (5 listed)
- Medullary thyroid carcinoma, MEN syndrome type 2, malignancy
- Treatment for diabetic retinopathy//macular edema, pancreatitis, gastric emptying abnormality/bariatric surgery, liver disease, end-stage renal disease or dialysis, pregnancy
- Prior use of pramlintide or any GLP-1-RA except tirzepatide or dulaglutide
- Cardiovascular event, hospitalization for heart failure
- Concurrent use of both drugs i.e. tirzepatide and dulaglutide
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TirzepatideNew use of tirzepatide dispensing claim is used as the exposure. | Drug | Tirzepatide |
| DulaglutideNew use of dulaglutide dispensing claim is used as the reference. | Drug | Dulaglutide |
Primary outcome
First occurence of MACE (all-cause mortailty, myocardial infarction, or death)
Time frame: 1 day after cohort entry date until the first of outcome or censoring, up to 365 days
To evaluate the comparative effect of tirzepatide vs dulaglutide on time to first occurrence of MACE (all-cause mortailty, myocardial infarction, or death) in patients with T2DM and an established CVD when following the eligibility criteria of the SURPASS-CVOT trial: Individuals aged 40 years or older with T2DM and an established CVD.
3 secondary outcomes
Individual components of the primary endpoint, i.e., all-cause mortality, myocardial infarction, or stroke (Tirzepatide vs dulaglutide)
Time frame: 1 day after cohort entry date until the first of outcome or censoring, up to 365 days
Hernia
Time frame: 1 day after cohort entry date until the first of outcome or censoring, up to 365 days
Lumbar radiculopathy
Time frame: 1 day after cohort entry date until the first of outcome or censoring, up to 365 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2025.
- Derived from this study: PubMed 41207920Kruger N, Schneeweiss S, Desai RJ, Sreedhara SK, Kehoe AR, Fuse K, Hahn G, Schunkert H, Wang SV. Cardiovascular outcomes of semaglutide and tirzepatide for patients with type 2 diabetes in clinical practice. Nat Med. 2026 Jan;32(1):342-352. doi: 10.1038/s41591-025-04102-x. Epub 2025 Nov 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shirley Wang, PhD, ScM principal investigator
Brigham and Women's Hospital
Nils Krüger, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes and Major Adverse Cardiac Events, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First occurence of MACE (all-cause mortailty, myocardial infarction, or death) (time frame: 1 day after cohort entry date until the first of outcome or censoring, up to 365 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07088718, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2025.