Pooled analysis data showed improvements in glycaemic parameters, body weight and blood pressure with investigational agent empagliflozin* in adults with Type 2 Diabetes

Ingelheim, Germany and Indianapolis, US, Tuesday 24th September 2013 - Boehringer Ingelheim and Eli Lilly and Company today announced results from a new analysis of pooled efficacy data from four Phase III trials that showed treatment with investigational compound empagliflozin, a member of the sodium glucose cotransporter 2 (SGLT2) inhibitor class of drugs, improved glycaemic parameters, body weight and blood pressure, in adults with Type 2 Diabetes (T2D). Data from this pooled analysis are being presented at the 49th European Association for the Study of Diabetes (EASD) Annual Meeting.

"Management of Type 2 Diabetes in people with elevated cardiovascular risk represents a challenge for physicians" said John E. Gerich, M.D. Professor of Medicine and Physiology, University of Rochester School of Medicine. "Results from this pooled analysis showed that empagliflozin was associated with reductions of elevated blood pressure and modest body weight loss, in addition to improving glycaemic parameters. These are important considerations for people with Type 2 Diabetes."

The pooled analysis of four Phase III trials was based on efficacy data from 2,477 patients treated with empagliflozin (10mg or 25mg) for 24 weeks either as monotherapy or as add-on to metformin, metformin with sulphonylurea, or pioglitazone with or without metformin. This abstract only presented pooled efficacy data; pooled safety results were presented in a separate analysis.

At week 24, patients administered empagliflozin 10mg and 25mg showed:

• Significant reductions from baseline in HbA1c of 0.70 percent and 0.76 percent respectively, compared to a change of -0.08 percent for placebo
• Loss of 2.05kg and 2.25kg of body weight respectively from baseline, compared to a reduction of 0.24kg for placebo
• Reductions in systolic blood pressure of 3.9mmHg and 4.3mmHg, and diastolic blood pressure of 1.8mmHg and 2.0mmHg, respectively. Reductions of 0.5mmHg in systolic blood pressure and 0.6mmHg in diastolic blood pressure were achieved by patients treated with placebo
• Changes from baseline in LDL cholesterol of +3.1mg/dL and +3.9mg/dL respectively, versus a change of +0.8mg/dL for placebo
• Changes from baseline in HDL cholesterol of +2.7mg/dL for both doses, versus a change of 0.0mg/dL for placebo
• Changes from baseline in triglyceride levels of -9.7mg/dL and -1.8mg/dL respectively, versus a change of +2.7mg/dL for placebo
  

  
  
  

  
  

"The results presented today encourage us to further investigate the efficacy and cardiovascular safety of empagliflozin as a potential new treatment option for people with Type 2 Diabetes," said Professor Klaus Dugi, Senior Vice President Medicine, Boehringer Ingelheim.

In addition to the pooled analysis of efficacy data, Boehringer Ingelheim and Lilly are also presenting the design of the empagliflozin cardiovascular (CV) outcomes trial at the EASD annual meeting.

The long-term impact of treatment with empagliflozin on CV events is being investigated in a CV outcomes event trial in patients with T2D. The approximately four-year study of more than 7,000 patients with T2D at elevated CV risk, is investigating the long term treatment of empagliflozin versus placebo on CV morbidity and mortality in 42 countries at more than 620 sites.

The primary endpoint is time to first occurrence of CV death, non-fatal myocardial infarction (heart attack) or non-fatal stroke. In addition, the study is assessing long term blood glucose lowering efficacy, body weight changes, the incidence of hypoglycaemia and other safety measures. Recruitment for EMPA-REG OUTCOME^™ completed in April 2013 and the study is currently expected to complete in 2018.

About the empagliflozin Phase III clinical trial programme
Empagliflozin is being investigated in adults with T2D in a Phase III clinical trial programme, which has enrolled more than 14,500 patients. This programme comprises more than 10 multinational clinical trials.

About diabetes
An estimated 371 million people worldwide have Type 1 or Type 2 Diabetes. Type 2 Diabetes is the most common type, accounting for an estimated 90-95 percent of all diabetes cases. Diabetes is a chronic condition that occurs when the body either does not properly produce, or use, the hormone insulin.

Boehringer Ingelheim and Eli Lilly and Company
In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in the field of diabetes that centres on three compounds representing several of the largest diabetes treatment classes. This alliance leverages the companies’ strengths as two of the world’s leading pharmaceutical companies, combining Boehringer Ingelheim’s solid track record of research-driven innovation and Lilly’s innovative research, experience, and pioneering history in diabetes. 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
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 140 affiliates and more than 46,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.

Social responsibility is a central element of Boehringer Ingelheim's culture. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim’s endeavours.

In 2012, Boehringer Ingelheim achieved net sales of about €14.7 billion. R&D expenditure in the business area Prescription Medicines corresponds to 22.5% of its net sales.

About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organisations. Headquartered in Indianapolis, IN, Lilly provides answers – through medicines and information – for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.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 work to meet the diverse needs of people with diabetes through research and collaboration, a broad and growing product portfolio and a continued commitment to providing real solutions – from medicines to support programmes and more – to make lives better.

For more information, visit www.lillydiabetes.com.

This press release contains forward-looking statements about empagliflozin, an investigational compound that is being studied for Type 2 Diabetes. It reflects Lilly's current beliefs; however, as with any such undertaking, there are substantial risks and uncertainties in the process of drug development and commercialisation. There is no guarantee that future study results and patient experience will be consistent with study findings to date or that empagliflozin will receive regulatory approvals or prove to be commercially successful. For further discussion of these and other risks and uncertainties, please see Lilly's latest Forms 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.