Phase III data show significant reduction in blood glucose with investigational compound empagliflozin* added to metformin or metformin plus sulphonylurea in adults with type 2 diabetes

Data presented at the American Diabetes Association 73rd Scientific Sessions^® also show statistically significant reductions in mean daily glucose and body weight in people with type 2 diabetes

BURLINGTON AND TORONTO, ON, June 22, 2013 /CNW/ - Boehringer Ingelheim and Eli Lilly and Company today announced results of two Phase III 24-week clinical trials of the investigational agent empagliflozin¹ added to metformin with and without the addition of sulphonylurea, in people with type 2 diabetes mellitus (T2DM). The results showed statistically significant improvements in blood glucose as measured by reductions in HbA1c (average blood glucose) after 24 weeks among people who received empagliflozin.^1,2

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 T2DM. The emerging SGLT2 inhibitor class removes excess glucose through the urine by blocking glucose reabsorption by the kidney.

The study, presented at the American Diabetes Association (ADA) 73rd Scientific Sessions^®, also demonstrated statistically significant reductions in key secondary endpoints, including mean daily glucose concentration and body weight.^1,2 Overall, adverse events were reported in a similar percentage of patients treated with empagliflozin 10mg, empagliflozin 25mg and placebo.

"Physicians will welcome the availability of another agent in the fight against type 2 diabetes that can be added-on to metformin or metformin plus sulphonylurea," said Dr. Stewart Harris, CDA Chair in Diabetes Management and the Ian McWhinney Chair of Family Medicine Studies at Western University. "This new treatment regimen has the potential to demonstrate a significant reduction of blood glucose levels and also offer weight loss, something that will be encouraging to patients."

24-week study with empagliflozin as an add-on to metformin
In this 24-week randomised, double-blind, placebo-controlled trial, the addition of empagliflozin to a background of metformin showed a placebo-adjusted reduction in HbA1c of 0.57 per cent and 0.64 per cent (p<0.001) for empagliflozin 10mg (n=217) and 25mg (n=213), respectively, compared with placebo (n=207).¹ The study also showed a statistically significant placebo-adjusted reduction at 24 weeks in mean daily glucose concentration of 0.42mmol/L with empagliflozin 10mg (p=0.006) and 0.69mmol/L with empagliflozin 25mg (p<0.001).¹ Body weight also significantly decreased by 1.63kg and 2.01kg (p<0.001) with the addition of empagliflozin 10mg and 25mg, respectively, compared with metformin.¹

Drug-related adverse events were reported by 16.1 per cent, 12.6 per cent, and 12.1 per cent of patients on empagliflozin 10mg, empagliflozin 25mg, and placebo, respectively. Confirmed hypoglycemia was reported in 1.8 per cent of patients on empagliflozin 10mg, 1.4 per cent on empagliflozin 25mg and 0.5 per cent on placebo, none of which required assistance. Adverse events consistent with urinary tract infection were reported in 5.1 per cent of patients on empagliflozin 10mg, 5.6 per cent on empagliflozin 25mg and 4.9 per cent on placebo. Adverse events consistent with genital infection were reported in 3.7 per cent of patients on empagliflozin 10mg, 4.7 per cent on empagliflozin 25mg and 0.0 per cent on placebo.

24-week study with empagliflozin as an add-on to metformin and sulphonylurea
In this 24-week randomised, double-blind, placebo-controlled trial, the addition of empagliflozin to a background of metformin plus sulphonylurea therapy showed a placebo-adjusted reduction in HbA1c of 0.64 per cent and 0.59 per cent (p<0.001) for empagliflozin 10mg (n=225) and 25mg (n=216), respectively, compared with placebo (n=225).² The study also showed a statistically significant placebo-adjusted reduction at 24 weeks in mean daily glucose concentration of 0.56mmol/L and 0.72mmol/L (p<0.001) with empagliflozin 10mg and 25mg, respectively.² Reductions in body weight were significantly greater with the addition of empagliflozin to metformin plus sulphonylurea (change in body weight of 1.75 kg, 10mg; and 1.99 kg, 25mg; p<0.001). ²

Drug-related adverse events were reported by 24.1 per cent, 19.8 per cent and 15.5 per cent of patients on empagliflozin 10mg, empagliflozin 25mg and placebo, respectively. Confirmed hypoglycaemia was reported in 16.1 per cent of patients on empagliflozin 10mg, 11.5 per cent on empagliflozin 25mg and 8.4 per cent on placebo; none of which required assistance. Adverse events consistent with urinary tract infection were reported in 10.3 per cent of patients on empagliflozin 10mg, 8.3 per cent on empagliflozin 25mg and 8.0 per cent on placebo. Adverse events consistent with genital infection were reported in 2.7 per cent of patients on empagliflozin 10mg, 2.3 per cent on empagliflozin 25mg and 0.9 per cent on placebo.

About the empagliflozin phase III clinical trial program
Empagliflozin is being investigated in adults with T2DM in a Phase III clinical trial program that plans to enrol more than 14,500 patients. This program comprises more than 10 multinational clinical trials, including a large cardiovascular outcomes trial.

About Diabetes
An estimated 371 million people worldwide³ have type 1 or type 2 diabetes. Type 2 diabetes is the most common type, accounting for an estimated 90 per cent of all diabetes cases.⁴ Diabetes is a chronic condition that occurs when the body either does not properly produce, or use, the hormone insulin.⁵ Today, more than 9 million Canadians live with diabetes or prediabetes - a condition that, if left unchecked increases the risk of developing type 2 diabetes.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 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 (Canada) Ltd.
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 endeavors.

In 2012, Boehringer Ingelheim achieved net sales of about 14.7 billion euro. R&D expenditure in its Prescription Medicines business corresponds to 22.5 per cent of its net sales.

The Canadian headquarters of Boehringer Ingelheim was established in 1972 in Montreal, Quebec and is now located in Burlington, Ontario.  Boehringer Ingelheim employs more than 550 people across Canada.

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

About Eli Lilly Canada Inc.
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Indiana, Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs. Eli Lilly Canada, headquartered in Toronto, Ontario, employs close to 500 people across the country. Additional information about Eli Lilly Canada can be found at www.lilly.ca.

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.

*Empagliflozin is an investigational compound. Its safety and efficacy have not yet been fully established and is not currently authorized for sale in Canada.

References
________________________________
¹ Häring H et al, Empagliflozin as Add-On to Metformin for 24 Weeks Improves Glycemic Control in Patients with Type 2 diabetes (T2DM). Poster No: 1092-P. Presented at the American Diabetes Association® (ADA) 73rd Scientific Sessions. June 21-25, Chicago, IL.
² Häring H et al, Empagliflozin as Add-On to Metformin Plus Sulfonylurea (SU) for 24 Weeks Improves Glycemic Control in Patients with Type 2 diabetes (T2DM). Poster No: 1082-P. Presented at the American Diabetes Association® (ADA) 73rd Scientific Sessions. June 21-25, Chicago, IL.
³ International Diabetes Federation. Diabetes Atlas, 5th Edition: Fact Sheet. 2012.
⁴ Canadian Diabetes Association. Diabetes facts. Available at http://www.diabetes.ca/diabetes-and-you/what/facts/ Accessed on May 24, 2013
⁵ International Diabetes Federation. IDF Diabetes Atlas, 5th Edition: What is Diabetes? http://www.idf.org/diabetesatlas/5e/what-is-diabetes. Accessed on: April 4, 2013
⁶ Canadian Diabetes Association. The Harsh Reality. Available at http://www.diabetes.ca/diabetes-and-you/living/harsh-reality/ Accessed on: May 24, 2013

SOURCE: Boehringer Ingelheim

Jennifer Mota
Brand Communication Associate
Boehringer Ingelheim (Canada) Ltd.
Email: [email protected]
Phone: [phone]

Helen Stone
Manager, Communications
Eli Lilly Canada Inc.
Email: [email protected]
Phone: [phone]