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.
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 |
|
| 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 | Up to 5.5-year follow-up for primary outcome |