What is this study trying to find out about type 2 diabetes and cardiovascular disease?

This study is evaluating two different medication types to see how they affect heart, kidney, and death events in people with type 2 diabetes who have or are at high risk for cardiovascular disease. The goal is to understand which treatment may better reduce these serious health issues. The research is led by Brigham and Women's Hospital.

Who may be eligible for this type 2 diabetes clinical trial?

Adults aged 40 to 80 years with diagnosed type 2 diabetes and established or high-risk atherosclerotic cardiovascular disease may be eligible. Participants must meet certain health criteria including specific blood sugar levels and kidney function, and be willing to use the study medications and share medical records. Please review eligibility criteria for more details.

Is there any cost to participate in this type 2 diabetes clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel and other expenses are not guaranteed to be covered and may vary depending on individual circumstances.

Actively Recruiting

Phase 4

Age: 40Years - 80Years

All Genders

ID05390892

Study Comparing Two Medication Treatments to Prevent Heart and Kidney Problems in Adults with Type 2 Diabetes and Cardiovascular Disease or High Risk

Led by Brigham and Women's Hospital · Updated on 2026-04-13

6000

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating two treatment options for people with type 2 diabetes who also have established or high-risk atherosclerotic cardiovascular disease ASCVD. This clinical trial aims to compare the total number of heart, kidney, and death events between treatments using sodium-glucose cotransporter-2 inhibitors SGLT2i and glucagon-like peptide-1 receptor agonists GLP-1 RA. The study involves 6,000 participants and seeks to better understand how these medications affect health outcomes in this population. Participants will be randomly assigned to receive either an SGLT2 inhibitor canagliflozin, dapagliflozin, or empagliflozin or a GLP-1 receptor agonist dulaglutide, liraglutide, or semaglutide, all of which have shown cardiovascular benefits. The study is open label, meaning both participants and researchers know which treatment is given. Treatment assignment is balanced evenly between the two groups, and participants will continue their assigned therapy throughout the study. During the trial, researchers will monitor participants for events including heart attacks, strokes, arterial revascularization, hospitalizations for heart failure, kidney failure, kidney transplants, and death. Follow-up will last for an average of about three years. Data will be collected through medical records and electronic health information, with ongoing tracking of health status and treatment adherence to assess the total number of these cardiovascular and kidney-related events.

CONDITIONS

Brief Title

PREvention of CardIovascular and DiabEtic kidNey Disease in Type 2 Diabetes

Who Can Participate

Age: 40Years - 80Years

All Genders

Eligibility Criteria

You may qualify if you...

Diagnosis of type 2 diabetes based on clinical evaluation
HbA1c of 6% or higher measured within 12 months before screening
Age between 40 and 80 years
Established atherosclerotic cardiovascular disease defined by coronary heart disease, cerebrovascular disease, or symptomatic peripheral artery disease
For primary prevention group (up to 30% of participants): age 60 to 80 years with at least one high-risk feature including active smoking, HbA1c 8% or higher, or stage 3a chronic kidney disease
Willingness to be randomly assigned to either SGLT2 inhibitor or GLP-1 receptor agonist medication class
Willingness to fill prescriptions through personal pharmacy and adjust other medications for safety
Willingness to avoid starting therapy from the alternative treatment group unless recommended by usual care provider
If currently taking one of the study medication classes, willingness to stop and be reassigned
Consent to data collection from electronic health records and medical releases

You will not qualify if you...

Diagnosis of diabetes types other than type 2 (such as type 1, pancreatogenic, or monogenic diabetes)
Use of multiple daily insulin injections without agreement from diabetes care provider to manage insulin adjustments
History of diabetic ketoacidosis
Presence of active diabetic foot ulcer
History of pancreatitis
Hospitalization for heart failure as primary reason within the past year
Left ventricular ejection fraction below 40%
Urinary albumin-to-creatinine ratio above 200 mg/g at screening
Estimated glomerular filtration rate below 45 ml/min/1.73m2 within 12 months before screening
Known inability to afford study medications through insurance
Women of child-bearing potential unwilling to use birth control
Active or planned cancer treatment, or recent cancer likely to interfere with study therapy before 2028, except stable cancers with no progression
History of solid organ or bone marrow transplant
Allergy to SGLT2 inhibitors or GLP-1 receptor agonists

Research Team

Brendan Everett, MD, MPH

Maureen Malloy

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Study Comparing Two Medication Treatments to Prevent Heart and Kidney Problems in Adults with Type 2 Diabetes and Cardiovascular Disease or High Risk

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria