Phase III data show investigational compound empagliflozin plus insulin significantly reduced HbA1c in adults with type 2 diabetes

RIDGEFIELD, Conn. and INDIANAPOLIS, June 22, 2013 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company (NYSE: LLY) today announced results of a 78-week phase III clinical trial of the investigational agent empagliflozin* as add-on to basal insulin in adults with type 2 diabetes (T2D). The study, presented at the American Diabetes Association 73rd Scientific Sessions^®, showed that empagliflozin 10 mg or 25 mg, plus insulin, produced statistically significant reductions in HbA_1c (average blood glucose) compared with insulin alone at the study's primary endpoint, week 18, as well as at week 78.¹

Empagliflozin is a member of the sodium glucose co-transporter-2 (SGLT2) inhibitor class of compounds, and is being investigated for the reduction of blood glucose levels in adults with T2D. The emerging SGLT2 inhibitor class removes excess glucose through the urine by blocking glucose re-absorption by the kidney.

"This study is part of the Boehringer Ingelheim and Lilly Diabetes alliance's clinical program designed to examine empagliflozin as an add-on therapy to a broad range of existing treatments for people with type 2 diabetes," said Christophe Arbet-Engels, MD, PhD, vice president, metabolic-clinical development and medical affairs, Boehringer Ingelheim Pharmaceuticals, Inc.

Results of the study with empagliflozin as add-on to basal insulin in people with T2D included the following:

• Placebo-adjusted reductions in HbA_1c for empagliflozin 10 mg and 25 mg by 0.6 percent and 0.7 percent (p<0.001), respectively, at week 18, and by 0.5 percent and 0.6 percent, respectively, at week 78 (p<0.001).¹ The study included an 18-week fixed insulin dose period, after which the dose was adjusted at investigator discretion.¹
• At week 78, the placebo-adjusted change in required daily insulin dose was decreased by 6.7 International Units (IU) and 6.0 IU for empagliflozin 10 mg (p=0.002) and 25 mg (p=0.009), respectively.¹

Drug-related adverse events were reported by 39 percent and 44 percent of patients on empagliflozin 10 mg and 25 mg, respectively, and by 31 percent of patients on placebo. Hypoglycemia was reported in 36 percent of patients on empagliflozin 10 mg and 25 mg, and by 35 percent on placebo. Two patients on empagliflozin 25 mg required assistance to treat the hypoglycemic event. Adverse events consistent with urinary tract infection were reported in 15 percent, 12 percent and 9 percent of patients on empagliflozin 10 mg, 25 mg and placebo, respectively. Adverse events consistent with genital infection were reported in 8 percent, 5 percent and 2 percent of patients on empagliflozin 10 mg, 25 mg and placebo, respectively.¹

About the Study
The 78-week, randomized, double-blind, placebo-controlled trial investigated the safety and efficacy of empagliflozin as an add-on compound in adults with T2D on basal insulin. Patients were randomized to receive empagliflozin 10 mg (n=169), empagliflozin 25 mg (n=155) or placebo (n=170). Basal insulin dose remained constant for the first 18 weeks. Thereafter, adjustments were allowed at investigator discretion. Primary endpoint was change from baseline in HbA_1c at week 18. Key secondary endpoints were changes from baseline in insulin dose and HbA_1c at week 78.¹

About the Empagliflozin Phase III Clinical Trial Program
Empagliflozin is being investigated in adults with T2D in a phase III clinical trial program that has enrolled more than 14,500 patients. This program includes more than 10 multinational clinical trials, including a large cardiovascular outcomes trial.

About Diabetes
Approximately 25.8 million Americans² and an estimated 371 million people worldwide³ have type 1 or type 2 diabetes. T2D is the most common type, accounting for an estimated 90 to 95 percent of all diabetes cases.² Diabetes is a chronic condition that occurs when the body does not properly produce or use the hormone insulin.⁴ Diabetes was estimated to cost the U.S. $245 billion in direct medical costs and reduced productivity in 2012.⁵

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 centers 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
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

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.

As a central element of its culture, Boehringer Ingelheim has a demonstrated commitment to corporate social responsibility. 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 endeavors.

In 2012, Boehringer Ingelheim achieved net sales of about $19.1 billion (14.7 billion euro). R&D expenditure in the business area Prescription Medicines corresponds to 22.5 percent of its net sales.

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

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 organizations. 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 programs and more – to make lives better.

For more information, visit www.lillydiabetes.com.

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This press release contains forward-looking statements about empagliflozin* for the treatment of 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 commercialization. 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.

CONTACT:

Catherine London
Associate Director, Public Relations
Boehringer Ingelheim Pharmaceuticals, Inc.
Email: [email protected]
Phone: (203) 798-4638

Tammy Hull
Communications Manager
Lilly Diabetes
Email: [email protected]  
Phone: (317) 651-9116

References

1. Rosenstock J, et al. Empagliflozin as Add-On to Basal Insulin for 78 Weeks Improves Glycemic Control with Weight Loss in Insulin-Treated Type 2 Diabetes (T2DM). Poster No: 1102-P. Presented at the American Diabetes Association (ADA) 73rd Scientific Sessions^®. June 21-25, Chicago, IL.
2. Centers for Disease Control and Prevention. National diabetes fact sheet: national estimates and general information on diabetes and pre-diabetes in the United States, 2011. Atlanta, GA: U.S. Department of Health and Human Services, Center for Disease Control and Prevention, 2011.
3. International Diabetes Federation. Diabetes Atlas, 5th Edition: Fact Sheet. 2012.
4. International Diabetes Federation. IDF Diabetes Atlas, 5th Edition: What is Diabetes? http://www.idf.org/diabetesatlas/5e/what-is-diabetes. Accessed on: June 18, 2013
5. American Diabetes Association. Economic costs of diabetes in the U.S. in 2012. Diabetes Care. 2013;36(4):1033-1046.

[*]Empagliflozin is an investigational compound. Its safety and efficacy have not been established.

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SOURCE Eli Lilly and Company; Boehringer Ingelheim Pharmaceuticals, Inc.