Recruiting

Testing two medications to prevent heart problems in people with type 2 diabetes

Plain-English translation of NCT05633810 on ClinicalTrials.gov ↗ · Source last updated March 2026 · Translation generated June 2026 · How we translate trials

Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.

What is this trial?

This trial is testing whether and non-enteric coated —used alone or together—can help prevent heart attacks and strokes in people with type 2 diabetes who are at higher risk for these events. The study involves 10,000 patients and is being run by the Montreal Heart Institute. Researchers want to see if this medication approach is safe and effective at protecting your heart and blood vessels.

People with type 2 diabetes face a significantly higher risk of heart disease and stroke, even when their blood sugar and cholesterol are well controlled. This trial exists to see whether this medication could offer additional protection beyond current standard diabetes care.

Do you qualify?

You likely qualify if…

you are between 55 and 80 years old
you have been diagnosed with type 2 diabetes and are being treated according to medical guidelines
you have never had a heart attack, angina, or coronary artery disease
you have at least one risk factor, such as diabetes lasting 5+ years, high blood sugar levels, active smoking, high cholesterol or triglycerides despite treatment, signs of heart or blood vessel damage, or diabetes-related complications like eye or nerve disease
if you are a woman of childbearing age, you have a negative pregnancy test and agree to use effective birth control throughout the study

You likely don't qualify if…

you have a history of heart attack, stroke, heart failure, or previous heart procedures
you have severe kidney disease (eGFR less than 35)
you have been diagnosed with cancer in the past 3 years (other than certain skin cancers)
you have inflammatory bowel disease, chronic diarrhea, or a recent peptic ulcer
you have a known neuromuscular disease or severely elevated muscle enzyme levels

What participation looks like

You would be randomly assigned to take either the medication, a placebo (inactive pill), or both, depending on whether you can safely take . You would continue taking your regular diabetes and heart medications as prescribed. The study involves regular clinic visits to check your health, blood work to monitor your response, and tracking of any heart-related events over the study period. Your doctor will monitor you closely to ensure the treatment is working and is safe for you.

AI-generated summary from trial data · Jun 16, 2026 · Not medical advice

Trial locations(39 sites)

Australia

Curtin University, Bentley, Western Australia

Canada

St. Michael's Hospital, Toronto, Ontario

Montreal Heart Institute, Montreal, Quebec

Denmark

Center for Translational Cardiology and Pragmatic Randomized Trial, Hellerup

Finland

Heart and Lung Center, Helsinki University Hospital and Helsinki University, Helsinki