‍A new cardiovascular indication for Canadians with type 2 diabetes

Type 2 diabetes and cardiovascular disease are closely connected. It is estimated that type 2 diabetes contributes to approximately 40% of heart attacks and 30% of strokes in Canada. For people managing both conditions at once, treatment decisions have historically required balancing multiple medications with different goals. This approval means that for eligible patients, Ozempic can now serve a dual purpose within a single treatment plan. Cardiovascular disease is also the second leading cause of death in Canada, which makes this an approval with broad implications for how high-risk patients with type 2 diabetes are managed going forward.

What the evidence showed

According to a Health Canada approval announced by Novo Nordisk on March 2, 2026, the new indication is based on a pooled analysis of four large clinical trials: SUSTAIN 6, PIONEER 6, FLOW, and SOUL. Together, these studies enrolled tens of thousands of adults with type 2 diabetes with elevated cardiovascular risk. Each trial was randomized, double-blinded, and placebo-controlled, and across all four, treatment with semaglutide demonstrated a reduction in the risk of major adverse cardiovascular events (MACE) compared to placebo when used alongside standard care.

A closer look at each trial

• SUSTAIN 6 followed 3,297 adults with type 2 diabetes and high cardiovascular risk over two years. Patients received once-weekly semaglutide injection alongside standard care. The trial evaluated cardiovascular outcomes and contributed to the overall evidence base supporting the pooled analysis. 
• PIONEER 6 studied 3,183 adults with type 2 diabetes and atherosclerotic cardiovascular disease, using an oral form of semaglutide over a median of 16 months. It demonstrated cardiovascular benefits with the oral formulation consistent with the broader findings. 
• FLOW focused on 3,533 adults with both type 2 diabetes and chronic kidney disease, following participants for a median of nearly 41 months. The trial showed that semaglutide delayed the progression of kidney disease and reduced the risk of cardiovascular death in this population. What form of semaglutide was used here? SC or oral?
• SOUL enrolled 9,650 adults with type 2 diabetes and established cardiovascular disease or chronic kidney disease. It was the largest of the four trials and evaluated oral semaglutide over an extended period, reinforcing the cardiovascular findings seen across the others.

Who this specifically applies to

The approval applies to adults who have type 2 diabetes and at least one of the following: established cardiovascular disease or chronic kidney disease. It is not a blanket expansion for all Ozempic users, and it does not change the existing approved use for blood sugar management. 

For patients who fall into this category, their prescribing physician now has stronger clinical grounds to recommend or continue Ozempic as part of a broader treatment plan that addresses cardiovascular risk alongside glycemic control.

What to do with this information

If you have type 2 diabetes and have been diagnosed with heart disease or chronic kidney disease, this update is worth raising with your doctor or endocrinologist at your next appointment. Your care team is best positioned to determine whether Ozempic is appropriate given your full medical history, current medications, and treatment goals. 

This approval does not change how Ozempic is accessed or prescribed in Canada. It remains a prescription medication, and eligibility is determined through a consultation with a licensed healthcare provider.

For the full details on Health Canada's approval, including the clinical trial data behind the decision, visit the Novo Nordisk announcement on Newswire.