• EMPERIAL clinical trials will evaluate the effect of Jardiance (empagliflozin) on exercise ability and heart failure symptoms in people with chronic heart failure
  • EMPERIAL is part of the most comprehensive clinical trial program of an SGLT2 inhibitor in chronic heart failure

RIDGEFIELD, CT and INDIANAPOLIS, IN, USA I March 6, 2018 I Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) today announced plans to expand their clinical trial program for Jardiance® in chronic heart failure with the EMPERIAL clinical trials. These trials will evaluate the effect of Jardiance on exercise ability and heart failure symptoms in people with chronic heart failure independent of whether they have type 2 diabetes. EMPERIAL comprises two Phase III trials that will assess the effect of 12 weeks of treatment with Jardiance on the ability of people with heart failure to perform daily exercise.

The plans for the EMPERIAL trials follow initiation of the EMPEROR trials in March 2017. While the EMPEROR outcome trials focus on long-term morbidity and mortality outcomes in people with heart failure, the EMPERIAL functional trials will investigate possible benefits on exercise capacity and heart failure symptoms. These studies are based on data obtained from the landmark EMPA-REG OUTCOME® trial, where the effect of Jardiance on heart failure outcomes was evaluated.

“Symptoms of heart failure can have a profound effect on quality of life, with more than three-quarters of people with heart failure finding it difficult to carry out routine activities,” said Jeff Emmick, M.D., Ph.D., vice president, Product Development, Lilly Diabetes. “Currently, there are limited treatment options that can help improve the everyday lives of people living with chronic heart failure. We look forward to seeing whether Jardiance can help address this unmet need.”

Heart failure is a serious condition where the heart is unable to pump enough blood around the body. It affects 26 million people worldwide, including more than 6 million Americans, and is associated with high morbidity and mortality. Approximately 50 percent of people who develop heart failure die within five years, and it is a leading cause of hospitalization in the United States and Europe.

“Boehringer Ingelheim and Lilly are committed to exploring how Jardiance can improve patient health outcomes and fill treatment gaps to serve as a broad cardiometabolic treatment option,” said Thomas Seck, M.D., vice president of Clinical Development and Medical Affairs – Primary Care, Boehringer Ingelheim Pharmaceuticals, Inc. “We were encouraged by the heart failure findings with Jardiance in the EMPA-REG OUTCOME trial and look forward to the additional data from our other ongoing trials.”

About EMPERIAL
EMPERIAL consists of two Phase III randomized, double-blind trials. The trials evaluate the effect of 12 weeks’ treatment of once-daily Jardiance 10 mg compared with placebo on exercise ability and heart failure symptoms in patients with chronic heart failure with preserved or reduced ejection fraction.* This will be measured by the 6-minute walk test, a common measure of functional exercise capacity.

  • EMPERIAL-preserved [NCT03448406]: will investigate Jardiance in patients with chronic heart failure with preserved ejection fraction (HFpEF). The study looks at a functional endpoint — how far patients can walk in 6 minutes — and at heart failure symptoms.
     
    • Primary endpoint: Change from baseline to week 12 in exercise capacity as measured by the distance walked in 6 minutes
    • Anticipated number of patients: approx. 300
    • Estimated completion: 2019
  • EMPERIAL-reduced [NCT03448419]: will investigate Jardiance in patients with chronic heart failure with reduced ejection fraction (HFrEF). The study looks at a functional endpoint — how far patients can walk in 6 minutes — and at heart failure symptoms. 
    • Primary endpoint: Change from baseline to week 12 in exercise capacity as measured by the distance walked in 6 minutes
    • Anticipated number of patients: approx. 300
    • Estimated completion: 2019

*Ejection fraction is a measurement of the percentage of blood leaving the heart each time it contracts. During each heartbeat pumping cycle, the heart contracts and relaxes. When the heart contracts, it ejects blood from the two pumping chambers (ventricles). When the heart relaxes, the ventricles refill with blood. 

HFpEF occurs when the heart muscle contracts normally but the ventricle muscles are stiff. They do not relax as they should when the ventricle fills with blood, so less blood can enter the heart compared to a normally functioning heart. 
HFrEF occurs when the heart muscle does not contract effectively and less blood is pumped out to the body compared to a normally functioning heart.
Both HFpEF and HFrEF lead to similar symptoms of heart failure, specifically difficulty breathing, swelling and fatigue.

About Heart Failure
Heart failure is a progressive, debilitating and potentially fatal condition that occurs when the heart cannot pump enough blood around the body. Symptoms of heart failure include difficulty breathing, swelling — most commonly in feet, legs and ankles — and fatigue, among others. Heart failure is a prevalent disease; 26 million people around the world and more than 6 million people in the United States have chronic heart failure. There is a high unmet need in the treatment of heart failure, as approximately 50 percent of people diagnosed with heart failure will die within five years. Additionally, heart failure represents the most common cause of hospitalization among individuals aged 65 years and over in the United States and Europe. Heart failure is highly prevalent in people with diabetes, but approximately half of all people with heart failure do not have diabetes.

What is JARDIANCE? (www.jardiance.com)
JARDIANCE is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

JARDIANCE is also used to reduce the risk of cardiovascular death in adults with type 2 diabetes who have known cardiovascular disease.

JARDIANCE is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).

Boehringer Ingelheim and Eli Lilly and Company
In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in diabetes that centers on compounds representing several of the largest diabetes treatment classes. This alliance leverages the strengths of two of the world’s leading pharmaceutical companies. By joining forces, the companies demonstrate commitment in the care of patients with diabetes and stand together to focus on patient needs. Find out more about the alliance at www.boehringer-ingelheim.com or www.lilly.com.

About Boehringer Ingelheim
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation.

Boehringer Ingelheim is one of the world’s top 20 pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with approximately 50,000 employees. Since its founding in 1885, the company has remained family-owned and today creates value through innovation for three business areas including human pharmaceuticals, animal health and biopharmaceutical contract manufacturing.

Boehringer Ingelheim is committed to improving lives and providing valuable services and support to patients and their families. Our employees create and engage in programs that strengthen our communities. Please visit our website to learn more about how we make more health for more people through our Corporate Social Responsibility initiatives.

In 2016, Boehringer Ingelheim achieved net sales of about $17.6 billion (15.9 billion euros). R&D expenditure corresponds to 19.6 percent of its net sales.

For more information please visit www.boehringer-ingelheim.us, or follow us on Twitter @BoehringerUS.

About Lilly Diabetes
Lilly has been a global leader in diabetes care since 1923, when we introduced the world’s first commercial insulin. Today we are building upon this heritage by working to meet the diverse needs of people with diabetes and those who care for them. Through research and collaboration, a wide range of therapies and a continued determination to provide real solutions—from medicines to support programs and more—we strive to make life better for all those affected by diabetes around the world. For more information, visit www.lillydiabetes.com.

About Eli Lilly and Company 
Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and newsroom.lilly.com/social-channels

SOURCE: Eli Lilly