Comparative Effectiveness of Dulaglutide, Semaglutide, and Tirzepatide in Preventing Cardiovascular Events in Patients With Type 2 Diabetes and Obesity With or Without Atherosclerotic Cardiovascular Disease.
Comparing diabetes drugs for heart health in patients with type 2 diabetes and obesity.
Plain English Summary
INcreTin-based thERapies for Cardiovascular Event PrevenTion in Patients With and Without ASCVD (INTERCEPT-ASCVD) is a Not Applicable clinical trial sponsored by Brigham and Women's Hospital studying Type 2 Diabetes, Overweight, ASCVD. This study compares how well dulaglutide, semaglutide, and tirzepatide prevent heart problems in people with type 2 diabetes and obesity. It is for adults with type 2 diabetes and obesity, some of whom have existing heart disease. This is an observational study using existing health records, so participation involves being part of the data analysis. There are no direct alternatives for patients to join this specific study, but these medications are already available for treatment. The trial aims to enroll 60000 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. You may be included if you have type 2 diabetes, are overweight or obese (BMI >= 25), and have or do not have a history of atherosclerotic cardiovascular disease (ASCVD). You will not be included if you have type 1 diabetes, certain rare conditions like medullary thyroid carcinoma or MEN syndrome type 2, malignancy, or are pregnant. Exclusion also applies if you have end-stage kidney disease, uncontrolled eye problems related to diabetes, or have had bariatric surgery. Previous use of certain diabetes medications or concurrent use of multiple study drugs will also exclude you. This trial is studying Type 2 Diabetes, Overweight, ASCVD, so participants generally need a confirmed diagnosis.
What They're Measuring
The study will measure how often patients experience heart attacks, strokes, or death, helping to understand which medication offers the best protection against these major health risks. The specific primary outcome measures are: Composite of myocardial infarction, stroke, or all-cause mortality. (Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i); Composite of myocardial infarction, or stroke. (Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i); Composite of myocardial infarction, stroke, or all-cause mortality. (Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i); Composite of myocardial infarction, or stroke. (Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial is important because it will provide real-world evidence on which of these commonly used diabetes medications is most effective at preventing serious cardiovascular events in a large and di This research targets Type 2 Diabetes, Overweight, ASCVD, where improved treatment options are needed.
Investor Insight
This observational study leverages large claims databases to compare the effectiveness of popular diabetes and weight-loss drugs, indicating a significant market interest in cardiovascular outcomes fo The large enrollment target of 60000 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor about the risks and benefits of dulaglutide, semaglutide, tirzepatide, and sitagliptin for your specific health situation. Understand that this study uses existing health data, so your day-to-day involvement is minimal, but your medical history will be analyzed. Discuss with your doctor if you have any of the exclusion criteria, such as kidney disease or specific medical conditions, before considering treatment with these medications. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: OBSERVATIONAL
- Enrollment: 60,000 participants
Interventions
- DRUG: Dulaglutide — Initiation of dulaglutide dispensing claim is used as the exposure.
- DRUG: Semaglutide — Initiation of semaglutide dispensing claim is used as the exposure.
- DRUG: Tirzepatide — Initiation of tirzepatide dispensing claim is used as the exposure.
- DRUG: Sitagliptin — Initiation of sitagliptin dispensing claim is used as the reference.
Primary Outcomes
- Composite of myocardial infarction, stroke, or all-cause mortality. (Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i)
- Composite of myocardial infarction, or stroke. (Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i)
- Composite of myocardial infarction, stroke, or all-cause mortality. (Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i)
- Composite of myocardial infarction, or stroke. (Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i)
Secondary Outcomes
- Myocardial infarction (Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i)
- Stroke (Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i)
- All-cause mortality (Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i)
- Composite of myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization. (Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i)
- Composite of myocardial infarction, stroke, hospitalization for unstable angina, coronary revascularization, or hospitalization for heart failure. (Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i)
Full Eligibility Criteria
The database analyses will be new-user active-comparative studies, conducted using 3 national United States claims databases, where we compare the effect of dulaglutide, semaglutide, and tirzepatide vs sitagliptin on preventing atherosclerotic cardiovascular events. Optum: Eligible cohort entry period from September 18, 2014 to August 31, 2025. Marketscan: Eligible cohort entry from October 1, 2016 to October 31, 2023. Medicare: Eligible cohort entry from September 18, 2014 to October 31, 2020. POPULATION WITH ASCVD Inclusion Criteria: * History of ASCVD (defined as MI, ACS, stable/unstable angina surgical or percutaneous coronary/other arterial revascularization procedure, ischemic stroke, TIA, aortic aneurysm, peripheral artery disease) * BMI \>= 25.0kg/m2 * Type 2 Diabetes Exclusion Criteria: * Medullary thyroid carcinoma * MEN syndrome type 2 * Malignancy * Type 1 diabetes or secondary diabetes * End-stage renal disease or dialysis * Uncontrolled diabetic retinopathy or maculopathy * Pregnancy * Bariatric surgery * Prior use of pramlintide, or any GLP-1RA except injectable semaglutide/tirzepatide/dulaglutide, or any DPP4i except sitagliptin * CV-event or intervention * Concurrent use of both study drugs POPULATION WITHOUT ASCVD Inclusion Criteria: * BMI \>=25.0kg/m2 * Type 2 diabetes Exclusion Criteria: * History of ASCVD (defined as MI, ACS, stable/unstable angina surgical or percutaneous coronary/other arterial revascularization procedure, ischemic stroke, TIA, aortic aneurysm, peripheral artery disease) * Medullary thyroid carcinoma * MEN syndrome type 2 * Malignancy * Type 1 diabetes or secondary diabetes * End-stage renal disease or dialysis * Uncontrolled diabetic retinopathy or maculopathy * Pregnancy * Bariatric surgery * Prior use of pramlintide, or any GLP-1RA except injectable semaglutide/tirzepatide/dulaglutide, or any DPP4i except sitagliptin * Concurrent use of both study drugs
Trial Locations
- Brigham and Women's Hospital, Boston, Massachusetts, United States
Frequently Asked Questions
What is clinical trial NCT07417618?
NCT07417618 is a Not Applicable OBSERVATIONAL study titled "INcreTin-based thERapies for Cardiovascular Event PrevenTion in Patients With and Without ASCVD (INTERCEPT-ASCVD)." It is currently active, not recruiting and is sponsored by Brigham and Women's Hospital. The trial targets enrollment of 60000 participants.
What conditions does NCT07417618 study?
This trial investigates treatments for Type 2 Diabetes, Overweight, ASCVD. The primary condition under study is Type 2 Diabetes.
What treatments are being tested in NCT07417618?
The interventions being studied include: Dulaglutide (DRUG), Semaglutide (DRUG), Tirzepatide (DRUG), Sitagliptin (DRUG). Initiation of dulaglutide dispensing claim is used as the exposure.
What does Not Applicable mean for NCT07417618?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT07417618?
This trial is currently "Active, Not Recruiting." It started on 2026-01-27. The estimated completion date is 2026-03.
Who is sponsoring NCT07417618?
NCT07417618 is sponsored by Brigham and Women's Hospital. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07417618?
The trial aims to enroll 60000 participants. The trial status is active, not recruiting.
How is NCT07417618 designed?
This is a observational study.
What are the primary outcomes being measured in NCT07417618?
The primary outcome measures are: Composite of myocardial infarction, stroke, or all-cause mortality. (Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i); Composite of myocardial infarction, or stroke. (Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i); Composite of myocardial infarction, stroke, or all-cause mortality. (Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i); Composite of myocardial infarction, or stroke. (Through study completion until first of outcome, disenrollment, end of study period, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA or DPP4i). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07417618 being conducted?
This trial is being conducted at 1 site, including Boston, Massachusetts (United States).
Where can I find official information about NCT07417618?
The official record for NCT07417618 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07417618. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07417618 testing in simple terms?
This study compares how well dulaglutide, semaglutide, and tirzepatide prevent heart problems in people with type 2 diabetes and obesity. It is for adults with type 2 diabetes and obesity, some of whom have existing heart disease.
Why is this trial significant?
This trial is important because it will provide real-world evidence on which of these commonly used diabetes medications is most effective at preventing serious cardiovascular events in a large and di
What are the potential risks of participating in NCT07417618?
Potential risks include gastrointestinal issues like nausea, vomiting, and diarrhea, which are common with these types of medications. Some individuals may experience more serious side effects such as pancreatitis, gallbladder problems, or allergic reactions. There is a small risk of thyroid tumors, particularly in individuals with a personal or family history of medullary thyroid carcinoma or MEN 2 syndrome. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07417618?
Ask your doctor about the risks and benefits of dulaglutide, semaglutide, tirzepatide, and sitagliptin for your specific health situation. Understand that this study uses existing health data, so your day-to-day involvement is minimal, but your medical history will be analyzed. Discuss with your doctor if you have any of the exclusion criteria, such as kidney disease or specific medical conditions, before considering treatment with these medications. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07417618 signal from an investment perspective?
This observational study leverages large claims databases to compare the effectiveness of popular diabetes and weight-loss drugs, indicating a significant market interest in cardiovascular outcomes fo This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
This is an observational study using existing health records, so participation involves being part of the data analysis. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.