OREANDA-NEWS. September 21, 2015.  "The Boehringer Ingelheim and Lilly Diabetes Alliance is very pleased to share the results of the EMPA-REG OUTCOME® trial with the healthcare community," said Prof. Hans-Juergen Woerle, Global Vice President Medicine, Boehringer Ingelheim. “Cardiovascular disease is the number one cause of death in people with type 2 diabetes worldwide and reducing cardiovascular risk, including death, is an essential component of diabetes management.”

About EMPA-REG OUTCOME®
EMPA-REG OUTCOME® was a long-term, multicentre, randomised, double-blind, placebo-controlled trial that involved more than 7,000 patients from 42 countries with type 2 diabetes at high risk for cardiovascular events. There were 772 primary outcome events in the EMPA-REG OUTCOME® trial over a median observation period of 3.1 years.

The study was designed to assess the effect of Jardiance® (10mg or 25mg once daily) added to standard of care compared with placebo added to standard of care. The primary endpoint was defined as time to first occurrence of either CV death, or non-fatal heart attack or non-fatal stroke. The study was designed to first test for non-inferiority and then for superiority.

Standard of care was comprised of glucose-lowering agents and cardiovascular drugs (including blood pressure and cholesterol-lowering medications).

Of the 7,020 treated patients, more than 97 percent completed the trial and vital status was available for more than 99 percent of these patients at study end. Analyses and results were independently validated and confirmed by the University of Freiburg, Germany an internationally renowned Academic Centre specializing in statistical analyses.

About Jardiance®
Jardiance® (empagliflozin) is an oral, once daily, highly selective sodium glucose co-transporter 2 (SGLT2) inhibitor approved for use in Europe, the United States and other markets around the world for the treatment of adults with type 2 diabetes.

Jardiance® works by blocking the reabsorption of glucose (blood sugar) by the kidney, leading to urinary glucose excretion, and lowering blood glucose levels in people with type 2 diabetes. SGLT2 inhibition targets glucose directly and works independently of ?-cell function and the insulin pathway.

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

Intended audiences
This press release is issued from Boehringer Ingelheim Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where Boehringer Ingelheim and Eli Lilly and Company do business.

Boehringer Ingelheim and Eli Lilly and Company
In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in diabetes that centres on compounds representing several of the largest diabetes treatment classes. The 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. Depending on geographies, the companies either co-promote or separately promote the respective molecules each contributed to the alliance.

Boehringer Ingelheim
 The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally with 146 affiliates and a total of more than 47,700 employees. The focus of the family-owned company, founded in 1885, is researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine.

Social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects, such as the initiative “Making more Health” and caring for the employees. Respect, equal opportunities and reconciling career and family form the foundation of the mutual cooperation. In everything it does, the company focuses on environmental protection and sustainability.

In 2014, Boehringer Ingelheim achieved net sales of about 13.3 billion euros. R&D expenditure corresponds to 19.9 per cent of its net sales.

For more information please visit www.boehringer-ingelheim.com

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 broad and growing product portfolio 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.