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Study evaluating the efficacy and safety of empagliflozin* presented during a late-breaking session at the American Diabetes Association’s (ADA) 72nd Scientific Sessions®
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Ingelheim, Germany and Indianapolis, US, June 09, 2012 – Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) presented study results that showed the investigational SGLT-2 inhibitor empagliflozin*, alone or as an add-on to metformin, reduced haemoglobin A1c (HbA1c) levels, fasting plasma glucose (FPG) and body weight when given to adults with type 2 diabetes for up to 90 weeks.1 HbA1c is an index of blood glucose control for the previous two to three months. The new data, from a Phase IIb open-label extension study, were presented as a late-breaking abstract at ADA.
Empagliflozin* is a member of an emerging class of compounds called sodium glucose co-transporter-2 (SGLT-2) inhibitors, which lower high blood glucose levels (hyperglycaemia) independently of insulin by blocking glucose reuptake in kidneys and thereby excreting excess glucose via the urine. This results in lowering HbA1c and weight irrespective of beta cell function or insulin resistance.1
"Type 2 diabetes is characterised by three main factors: persistent hyperglycaemia, impaired insulin secretion and increased insulin resistance," said Dr Hans-Juergen Woerle, Vice President Medicine Therapeutic Area Metabolism, Boehringer Ingelheim. "SGLT-2 inhibitors such as empagliflozin represent an innovative, insulin-independent mode of action. To date, clinical data have demonstrated that these drugs have the potential to improve persistent hyperglycaemia irrespective of the two other factors."
In the study, adults with type 2 diabetes (n=659) who participated in one of two 12-week Phase IIb empagliflozin trials, were treated for an additional 78 weeks with 10 mg or 25 mg of empagliflozin (monotherapy or add-on to metformin), metformin alone, or sitagliptin as add-on to metformin.
At week 90, decreases from baseline in mean HbA1c levels (%), and body weight (kg) were observed with empagliflozin 10 mg alone (-0.34%; -2.24 kg) and 25 mg alone (-0.47%; -2.61 kg), versus metformin alone (-0.56%, -1.28 kg).1 When used as an add-on to metformin, decreases from baseline in mean HbA1c levels and body weight were observed with empagliflozin 10 mg (-0.34%; -3.14 kg) and 25 mg (-0.63%; -4.03 kg), versus sitagliptin (-0.40%, -0.41 kg).1
The study showed empagliflozin (10 mg or 25 mg) was generally well-tolerated when given for a treatment duration of up to 90 weeks.1 More than 90% of the adverse events (AEs) reported were mild or moderate. Between 0.9 and 3.6% of patients on empagliflozin reported hypoglycaemic events, versus 7.1% on metformin only and 5.4% on sitagliptin. AEs related to urinary tract infections were reported in 3.8 to 12.7% of patients on empagliflozin, 3.6% of patients on metformin only, and 12.5% of patients on sitagliptin. AEs related to genital infections were reported in 3.0 to 5.5% of patients on empagliflozin, 1.8% of patients on metformin only, and none of the patients on sitagliptin.1
Empagliflozin is currently in Phase III clinical development with over 14,500 patients planned to be enrolled.
"The Boehringer Ingelheim and Eli Lilly and Company alliance is leveraging the collective scientific expertise of two leading research-driven pharmaceutical companies to address patient needs arising from the growing global diabetes epidemic," said Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. "We are committed to developing medications to help patients with diabetes throughout the course of their condition."
Safety and Efficacy of Empagliflozin as Monotherapy or Add-On to Metformin in a 78-Week Open-Label Extension Study in Patients With Type 2 Diabetes
In the extension study, patients treated with 10 mg or 25 mg of empagliflozin (monotherapy or add-on to metformin), metformin alone, or sitagliptin as add-on to metformin in one of two 12-week trials continued on the same treatment for an additional 78 weeks. Patients who had received 1,5 or 50 mg of empagliflozin or placebo in the 12-week trials were re-randomised to 78 weeks of treatment with either 10 mg or 25 mg of empagliflozin (monotherapy or add-on to metformin). Results for empagliflozin monotherapy were compared with those of patients treated with metformin alone, while data among patients on empagliflozin plus metformin were compared with those of patients on sitagliptin.
An estimated 366 million people worldwide have type 1 and type 2 diabetes.2 Type 2 Diabetes is the most common type, accounting for an estimated 90 percent of all diabetes cases.3 Diabetes is a chronic condition that occurs when the body either does not properly produce, or use, the hormone insulin.4
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 four pipeline compounds representing several of the largest 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 145 affiliates and more than 44,000 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 pledges to act socially responsible. 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 2011, Boehringer Ingelheim achieved net sales of about 13.2 billion euro. R&D expenditure in the business area Prescription Medicines corresponds to 23.5% of its net sales.
For more information please visit www.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.
This press release contains forward-looking statements about the investigational compound 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 commercialiation. There is no guarantee that future study results and patient experience will be consistent with study findings to date, that empagliflozin will receive required 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.
1BI/Lilly Data. Woerle HJ, Ferrannini E, Berk A, et al. Safety and Efficacy of Empagliflozin as Monotherapy or Add-On Therapy to Metformin in a 78-Week Open-Label Extension Study in Patients With Type 2 Diabetes. Poster No. 49-LB. Presented at the American Diabetes Association’s (ADA’s) 72nd Scientific Sessions®. June 8-12, Philadelphia, PA.
2International Diabetes Federation. IDF Diabetes Atlas, 5th Edition: The Global Burden. 2011. http://www.idf.org/diabetesatlas/5e/the-global-burden. Accessed on: April 11, 2012.
3Centers for Disease Control and Prevention. National diabetes fact sheet: national estimates and general information on diabetes and prediabetes in the United States, 2011. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, 2011.
4International Diabetes Federation. IDF Diabetes Atlas, 5th Edition: What is Diabetes? http://www.idf.org/diabetesatlas/5e/what-is-diabetes. Accessed on: April 11, 2012.
*Empagliflozin is an investigational compound. Its safety and efficacy has not yet been fully established