LEADER results announced at #2016ADA – compared to placebo, Victoza reduces risk of cardiovascular death by 22%, plus a 22% reduction in kidney disease and 31% reduction in severe hypoglycemia. More results from this groundbreaking trial.

Breaking news from New Orleans, where we are on the ground at the American Diabetes Association Scientific Sessions. In what was by far the most anticipated session of the entire conference, results from the LEADER clinical trial were just announced in a hall jam-packed with thousands of attendees. The LEADER trial compared the use of Victoza, a once-daily injection GLP-1 agonist, to placebo over a long period of time in 9,340 people with type 2 diabetes at high risk for heart disease.

What were the key results? Relative to placebo, Victoza caused:

• 22% risk reduction of cardiovascular death

• 22% risk reduction of kidney disease

• 31% risk reduction of severe hypoglycemia

• 12% risk reduction of non-fatal heart attacks – this result was not statistically significant, meaning it’s possible this result was due to chance

• 11% risk reduction of non-fatal strokes – this result was also not statistically significant

The speakers emphasized that the results should only be applied to the specific patient population enrolled in LEADER – those with longstanding type 2 diabetes and high risk of heart disease. Additionally, this “cardio-protection” was seen primarily in those with an established history of cardiac disease. Those who only showed risk factors for heart disease (high blood pressure, high cholesterol, etc.) did not see a significant benefit (though this may just be because there were comparatively few patients in the trial at high risk for heart disease but no established heart disease).

Bottom line: What an important news flash for people with diabetes! GLP-1 Victoza reduces the risk of death from heart disease, kidney disease, hypoglycemia, severe hypoglycemia, and other complications in people with type 2 diabetes at high risk for heart disease. Victoza is now the second diabetes drug to demonstrate it improves heart health in people with diabetes, following Lilly/BI’s Jardiance last year (an SGLT-2 inhibitor drug taken as a pill). We look forward to hearing how diabetes guidelines and standards will change as a result of Victoza's cardioprotection (in other words, heart safety) and renal protection (kidney safety) and look forward to future news of combination therapy in people with type 2 diabetes. The full results of this study can also be found in the just-published report in the New England Journal of Medicine.

Thank you incredibly to all the researchers and scientists and broader healthcare teams throughout the world who worked on this important large-scale trial and to the nearly 10,000 patients with diabetes who participated in the trials and contributed to this remarkable result. For additional background, please see our LEADER Q&A below, published in our original coverage of the LEADER trial last March.

LEADER Q&A

How was the trial designed?

The trial enrolled 9,340 type 2 patients at high risk of cardiovascular disease (with either existing cardiovascular disease or multiple risk factors) and was designed to last for five years or until over 633 cardiovascular events (heart attack, stroke, or death) had taken place. Participants were randomized to either take Victoza or a placebo throughout the trial.

What caused the improvements to the heart?

According to Novo Nordisk’s Chief Medical Officer Mads Thomsen, the results were driven partly by better glucose control and partly by other factors, including improved weight, blood pressure, lipids, and inflammation.

What does this mean for the GLP-1 agonist class?

Depending on the magnitude of the risk reduction, there is hope that the label on GLP-1 agonists could be improved to reflect their cardioprotective (“heart healthy”) benefits. That could encourage more insurance companies to cover them, more prescribers to recommend them, and more people with diabetes to use them.

What are GLP-1 agonists? (Byetta, Bydureon, Lyxumia, Tanzeum, Trulicity, Victoza)

GLP-1 is a hormone produced in the small intestine that stimulates insulin secretion and prevents glucagon secretion, thereby lowering blood sugar. It also acts to make you less hungry and to feel full faster. GLP-1 agonists are most often used by people with type 2 diabetes who have inadequate blood glucose control with just metformin and/or other oral drugs. They can be taken alone, or alongside metformin and/or other diabetes drugs. They work really well with insulin too. They have stronger efficacy than DPP-4 inhibitors but also increased side effects, particularly nausea. See more on GLP-1 agonists here. -ER/AJW/JC/NK