Phase III data show significant reductions in blood glucose with investigational compound empagliflozin used as monotherapy 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 24-week phase III clinical trial, which showed that treatment with the investigational compound empagliflozin* as monotherapy produced statistically significant reductions in HbA_1c (average blood glucose) versus placebo, in adults with type 2 diabetes (T2D) who had never received treatment or had not received treatment in the last 12 weeks.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.

Presented at the American Diabetes Association 73rd Scientific Sessions^®, the study in people with T2D (n=899) investigated the safety and efficacy of two doses (10 mg and 25 mg) of empagliflozin for 24 weeks.¹ Results of the primary endpoint showed placebo-adjusted reductions in HbA_1c from baseline to week 24 of 0.74 percent and 0.85 percent (p<0.001) for the 10 mg and 25 mg doses, respectively.¹ Sitagliptin 100 mg (which was used as an active comparator to validate the trial design and not for a head-to-head comparison with empagliflozin) showed a reduction in HbA_1c of 0.73 percent compared to placebo (p<0.001).¹

Study findings at 24 weeks also showed significant improvements with empagliflozin in secondary endpoints¹:

• Findings included statistically significant placebo-adjusted reductions in systolic blood pressure of 2.6 mmHg for empagliflozin 10 mg (p=0.023) and 3.4 mmHg for empagliflozin 25 mg (p=0.003).¹ Sitagliptin 100 mg did not show a statistically significant change in systolic blood pressure versus placebo.¹
• After 24 weeks, body weight significantly decreased by 4.25 lbs and 4.74 lbs (p<0.001) in patients treated with empagliflozin 10 mg and 25 mg, respectively, versus placebo.¹ Sitagliptin 100 mg showed a weight increase of 1.15 lbs versus placebo (p=0.036).¹
• Changes in diastolic blood pressure were statistically significant for the empagliflozin 25 mg treatment group only (1.9 mmHg reduction versus 0.5 mmHg reduction for placebo, p=0.030).¹

"Adults with type 2 diabetes have an increased risk of developing serious health problems and are tasked with managing their disease," said Christophe Arbet-Engels, MD, PhD, vice president, metabolic-clinical development and medical affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "With more than 330 million people worldwide living with type 2 diabetes, varied treatment options are needed to help these people better manage their condition."

The proportions of patients reporting drug-related adverse events from each study group were: 12.1 percent, empagliflozin 10 mg; 17.5 percent, empagliflozin 25 mg; 7.4 percent, placebo; and 8.5 percent, sitagliptin.¹ Adverse events consistent with urinary tract infection were reported in 6.7 percent and 5.4 percent of randomized patients on empagliflozin 10 mg and 25 mg, respectively, and in 5.2 percent on placebo and 4.9 percent on sitagliptin.¹ Adverse events consistent with genital infection were reported in 3.1 percent and 4.0 percent of patients on empagliflozin 10 mg and 25 mg, respectively, and in 0.0 percent on placebo and 0.9 percent on sitagliptin.¹ One patient in each study group experienced a confirmed hypoglycemic event, none of which required assistance.

Additionally, a subset of patients with baseline HbA_1c greater than 10 percent (mean=11.5 percent, N=87), which was above the study inclusion criteria, were placed on open-label empagliflozin 25 mg for 24 weeks and obtained a mean reduction of 3.7 percent from baseline HbA_1c.¹ Drug-related adverse events were reported by 12.6 percent of patients included in this subset.

About the study
The 24-week, randomized, double-blind, placebo-controlled trial investigated the safety and efficacy of empagliflozin in drug-naive patients with T2D. Patients were randomized to receive empagliflozin 10 mg (n=224) or 25 mg per day (n=224), sitagliptin 100 mg per day (n=223) or placebo (n=228) for 24 weeks. Patients with HbA_1c more than 10 percent (n=87) received open-label empagliflozin 25 mg per day for 24 weeks. The primary endpoint of the trial was change from baseline HbA_1c at week 24. Secondary endpoints were change from baseline in body weight, systolic blood pressure and diastolic blood pressure at week 24.¹

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. Roden M, et al. Empagliflozin Monotherapy Improves Glucose Control in Drug-Naive Patients with Type 2 Diabetes (T2DM). Poster No: 1085-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.