Project Summary

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

What is the research about?

Type 2 diabetes is a long-term illness that causes blood sugar levels to rise. Heart disease is a major cause of illness and death in patients with type 2 diabetes. Two new types of medicine that help keep blood sugar at normal levels may reduce serious health problems like stroke in people with diabetes and heart disease. These medicines are SGLT2 inhibitors and GLP-1 agonists. But questions remain about how these two types of medicine compare with each other.

In this study, the research team is looking at the use of these medicines, alone and in combination, in patients with diabetes and heart disease or at high risk for heart disease. The team wants to know how well these treatments work to prevent adverse health outcomes like heart attack, heart failure, stroke, kidney disease, and death.

Who can this research help?

Results may help patients who have or who are at risk for heart disease and their doctors when choosing medicines to treat type 2 diabetes. Results may also help medical societies to develop guidelines for diabetes care.

What is the research team doing?

The research team is enrolling 9,000 patients with type 2 diabetes who have or who are at high risk for heart disease. Patients are from health centers in several research networks. All patients are receiving usual care from their diabetes doctors. The team is assigning patients by chance to receive one of two types of diabetes medicines or a combination of both.

The research team is following patients for up to five and a half years to see how many major health problems patients have, such as stroke, heart attack, heart failure, kidney disease, or death. Also, the team is looking at patients’ health records and surveying patients to learn about:

  • Side effects from the medicines
  • If they take their medicine as directed
  • How satisfied they are with treatment
  • Their overall health
  • Their quality of life

Patients with diabetes and doctors and representatives from advocacy organizations are helping to plan and conduct the study.

Research methods at a glance

Design Element Description
Design Randomized controlled trial
Population 9,000 adults with type 2 diabetes who either (1) are ages 40–80 and have heart disease, or (2) have a high risk for heart disease, defined as men ages 50–80 or women ages 60–80 with risk factors for atherosclerotic cardiovascular disease
Interventions/
Comparators
  • A sodium-glucose cotransporter-2 (SGLT2) inhibitor (empagliflozin, dapagliflozin, or canagliflozin)
  • A glucagon-like peptide-1 (GLP-1) receptor agonist (dulaglutide, liraglutide, or semaglutide)
  • An SGLT2 inhibitor and a GLP-1 receptor agonist
Outcomes

Primary: composite of total number (first and recurrent) of episodes of myocardial infarction, stroke, arterial revascularization, hospitalization for heart failure, development of end-stage kidney disease, kidney transplantation, and mortality

Secondary: total burden of adverse events including severe hypoglycemic episodes, diabetic ketoacidosis, genital fungal infections, amputation, fractures, worsening diabetic retinopathy, pancreatitis, and gall bladder disease; overall health; quality of life; medication adherence; treatment satisfaction; atrial fibrillation

Timeframe Timeframe Length of follow-up for collecting data on primary outcomes. View Glossary Up to 5.5-year follow-up for primary outcome

Project Information

Brendan Everett, MD, MPH
Robert J. Glynn, PhD, Sc.D
Brigham and Women's Hospital
$30,819,128
PRECIDENTD (PREvention of CardIovascular and DiabEtic kidNey disease in Type 2 Diabetes)

Key Dates

July 2021
July 2028
2021

Study Registration Information

Tags

Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
Populations Populations PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders. View Glossary
Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: February 1, 2024