Phase III data show investigational compound empagliflozin significantly reduced blood glucose 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 two late-breaking presentations with results from a pooled analysis of four pivotal phase III trials of the investigational agent empagliflozin* in people with type 2 diabetes (T2D).

In the pooled analysis, presented at the American Diabetes Association 73rd Scientific Sessions^®, people with T2D treated with empagliflozin versus placebo achieved significant reductions in HbA_1c, fasting plasma glucose (FPG), weight and blood pressure after 24 weeks.¹ In the same analysis, people treated with empagliflozin vs. placebo experienced an increased frequency of genital infections, but not urinary tract infections (UTIs).²

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.

"We are primarily encouraged by the blood sugar lowering results seen in this analysis," said Christophe Arbet-Engels, PhD, vice president, metabolic-clinical development and medical affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "People with type 2 diabetes face different challenges. Many of them are not meeting their blood sugar level goals and have difficulties managing other factors such as weight and increased blood pressure."

About Posters #69-LB and #74-LB
Both posters are based on pooled data from 2,477 people with T2D who participated in one of four randomized, placebo-controlled phase III trials that investigated empagliflozin 10 mg or 25 mg given for 24 weeks as monotherapy or add-on to existing therapy, including metformin, metformin plus sulfonylurea, or pioglitazone with or without metformin.^1,2 Baseline HbA_1c levels were 8.02 percent for the placebo group, 7.98 percent for the empagliflozin 10 mg group, and 7.96 percent for the empagliflozin 25 mg group.^1,2

The placebo-adjusted efficacy results at 24 weeks for empagliflozin included:

• Reductions in HbA_1c of 0.62 percent and 0.68 percent (p<0.001) for 10 mg and 25 mg, respectively¹
• Decreases in FPG levels of 27.9 mg/dL and 30.6 mg/dL (p<0.001) for 10 mg and 25 mg, respectively¹
• Loss of 3.99 lbs and 4.43 lbs (p<0.001) in body weight for 10 mg and 25 mg, respectively¹
• Reductions in systolic blood pressure of 3.4 mmHg and 3.8 mmHg (p<0.001) with 10 mg and 25 mg, respectively¹
• Reductions in diastolic blood pressure of 1.2 mmHg and 1.5 mmHg (p<0.001) with 10 mg and 25 mg, respectively¹
• Reductions in uric acid of 0.50 mg/dL and 0.49 mg/dL (p<0.001 vs. placebo) with 10 mg and 25 mg, respectively, versus an increase of 0.02 mg/dL for placebo¹
• Changes in lipid parameters including:
  • LDL cholesterol (bad cholesterol) increased (3.1 mg/dL for 10 mg [p=0.060] and 3.9 mg/dL for 25 mg [p=0.008 vs. placebo]) versus an increase of 0.8 mg/dL for placebo¹
  • HDL cholesterol (good cholesterol) increased (2.7 mg/dL for 10 mg and 25 mg; p<0.001 vs. placebo) versus a change of 0.0 mg/dL for placebo¹
  • Triglycerides decreased (9.7 mg/dL for 10 mg [p=0.011 vs. placebo] and 1.8 mg/dL for 25 mg [p=0.321]) versus an increase of 2.7 mg/dL for placebo¹

For poster #74-LB, investigators analyzed the data pooled from the same four phase III studies to evaluate events consistent with UTIs and genital infections.²

The safety results with empagliflozin included:

• Incidence of UTIs comparable to placebo (9.3 percent and 7.5 percent for 10 mg and 25 mg, respectively, vs. 8.2 percent for placebo)²
  • <10 percent of patients experienced more than one event ²
  • Of the reported UTI episodes, most were mild in intensity
    • Mild: 7.5 percent for 10 mg; 6.7 percent for 25 mg, and 6.9 percent for placebo
    • Moderate: 1.7 percent for 10 mg; 0.9 percent for 25 mg, and 1.1 percent for placebo
    • Severe: 0.1 percent for 10 mg; 0 percent for 25 mg, and 0.2 percent for placebo
  • Low discontinuation rates (0.2 percent, 10 mg; 0.1 percent, 25 mg; 0.1 percent, placebo)²
• Incidence of genital infections higher than placebo (4.2 percent and 3.6 percent for 10 mg and 25 mg, respectively, vs. 0.7 percent for placebo)²
  • <5 percent of patients experienced more than one event²
  • Most episodes were mild (2.9 percent, 10 mg; 2.4 percent, 25 mg; 0.6 percent, placebo) to moderate (1.3 percent, 10 mg; 1.2 percent, 25 mg; 0.1 percent, placebo) in intensity²
  • Low discontinuation rates (0.1 percent, 10 mg; 0.2 percent, 25 mg; 0 percent, placebo)²

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 people. In total, this program includes more than 10 multinational clinical trials, including a large cardiovascular outcomes trial.

About Diabetes
Approximately 25.8 million Americans³ and an estimated 371 million people worldwide⁴ 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.³ Diabetes is a chronic condition that occurs when the body does not properly produce or use the hormone insulin.⁵ Diabetes was estimated to cost the U.S. $245 billion in 2012.⁶

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 people 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. Hach T, et al. Empagliflozin Improves Glycemic Parameters and Cardiovascular Risk Factors in Patients with Type 2 Diabetes (T2DM): Pooled Data from Four Pivotal Phase III Trials. Poster No. 69-LB. Presented at the American Diabetes Association 73^rd Scientific Sessions^®. June 21-25, Chicago, IL.
2. Kim G, et al. Empagliflozin (EMPA) Increases Genital Infections but Not Urinary Tract Infections (UTIs) in Pooled Data from Four Pivotal Phase III Trials. Poster No. 74-LB. Presented at the American Diabetes Association 73^rd Scientific Sessions^®. June 21-25, Chicago, IL.
3. 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.
4. International Diabetes Federation. Diabetes Atlas, 5th Edition: Fact Sheet. 2012.
5. International Diabetes Federation. Diabetes Atlas, 5th Edition: What is Diabetes? http://www.idf.org/diabetesatlas/5e/what-is-diabetes. Accessed on: June 18, 2013.
6. 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.