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New data presented at the 48th European Association for the Study of Diabetes (EASD) Annual Meeting highlight empagliflozin* as a potential new treatment for patients with Type 2 Diabetes (T2D), with additional blood pressure reduction
EX US & UK. Medical Media Only.
Berlin, Germany, 2nd October 2012 - Boehringer Ingelheim and Eli Lilly and Company today announced results of a pooled analysis of Phase IIb data for empagliflozin*, their investigational inhibitor of the sodium glucose co-transporter-2 (SGLT2).1
Empagliflozin* belongs to an innovative class of compounds, the SGLT2 inhibitors, and is currently being investigated for the reduction of blood glucose in patients with T2D.2 T2D is characterised by persistent hyperglycaemia (high blood glucose) along with declining beta cell function and increasing insulin resistance.3,4 Most classes of currently available oral T2D treatments depend on the actions of the hormone insulin to lower elevated blood glucose. SGLT2 inhibitors reduce glucose reabsorption in the kidney, leading to excretion of excess glucose via the urine. With a mode of action independent of insulin, SGLT2 inhibitors reduce blood glucose levels regardless of either insulin resistance or beta cell function. 2,5
The new, pooled Phase IIb data presented at the EASD Congress (PS 059 SGLT2 IV 770) examined the effect of empagliflozin* on blood pressure in addition to its primary action on HbA1c reduction and weight loss.1 Reductions in systolic blood pressure (SBP) of 4-5 mmHg from baseline were observed with empagliflozin*, with more pronounced reductions seen in patients with higher SBP (>140 mmHg at baseline).
Mean SBP at baseline of 131.3 mmHg and 132.5 mmHg were observed with empagliflozin* 10 mg and 25 mg, respectively, versus 134.3 mmHg with placebo. At week 12, reductions in mean SBP of 3.8 mmHg and 4.5 mmHg were observed with empagliflozin* 10 mg and 25 mg, respectively versus 1.2 mmHg for placebo. For both dosages the reduction from baseline in SBP was statistically significant versus placebo. In patients with higher SBP at baseline mean reductions of 17.0 mmHg and 13.4 mmHg were observed with empagliflozin* 10 mg and 25 mg, respectively, and 10.4 mmHg with placebo.
Reductions in diastolic blood pressure were greater with both empagliflozin* doses compared to placebo but did not reach statistical significance. Reductions in blood pressure were not correlated with reductions in weight or HbA1c.
Professor Michael Nauck, Head of the Diabeteszentrum Bad Lauterberg, Germany commented: "High blood pressure is an important contributor to higher cardiovascular death in people with T2D. Addressing elevated blood pressure should be an integral part of the management of T2D, together with elevated blood glucose."
Empagliflozin* was well-tolerated with the number of patients experiencing adverse events (AEs) comparable among the different treatment groups at week 12 (34.2% on empagliflozin* 10 mg, 31.6% on empagliflozin* 25 mg and 34.6% in placebo groups).1 The most commonly observed AEs include urinary tract and genital infections, generally categorised as mild, as seen in all clinical empagliflozin* trials to date.6
Empagliflozin* is currently being investigated in the largest Phase III clinical trial programme in diabetes with over 14,500 patients planned to be enrolled. The programme includes ten multi-national Phase III clinical trials, including a large cardiovascular outcome trial. Pivotal studies could complete in late 2012, with filing planned in the U.S. and Europe by 2013.
"The Boehringer Ingelheim and Lilly Alliance is excited about the promising profile of empagliflozin. We are looking forward to additional data for empagliflozin from our ongoing Phase III programme, including effects on blood pressure and body weight in addition to lowering blood glucose in patients with T2D." said Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim.
An estimated 366 million people worldwide have diabetes.7 Type 2 diabetes is the most common type, accounting for an estimated 90% of all diabetes cases.8 Diabetes is a chronic disease that occurs when the body either does not properly produce, or use, the hormone insulin.9
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.
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 organisations. 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 empagliflozin* tablets 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 commercialisation. There is no guarantee that future study results and patient experience will be consistent with study findings to date or that empagliflozin* will 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.
1Hach et al. The Sodium Glucose Cotransporter-2 (SGLT-2) Inhibitor Empagliflozin Lowers Blood Pressure Independent of Weight or HbA1c Change. Presented at the 48th European Association for the Study of Diabetes (EASD) Annual Meeting, Berlin, Germany. 2012 1-5 October 2012.
2Grempler R, Thomas L, Eckhardt M, Himmelsbach F, Sauer A, Sharp DE, et al. Empagliflozin, a novel selective sodium glucose cotransporter-2 (SGLT-2) inhibitor: characterisation and comparison with other SGLT-2 inhibitors. Diabetes, Obesity and Metabolism. 2012;14(1):83-90.
3Goldstein BJ. Expert column - understanding type 2 diabetes. The growing epidemic of type 2 diabetes. Medscape Diabetes & Endocrinology. 2006;14(9).
4DeFronzo R. From the triumvirate to the ominous octet: A new paradigm for the treatment of type 2 diabetes mellitus. Diabetes. 2009;58:773-95.
5Abdul-Ghani MA, DeFronzo R. Inhibition of renal glucose reabsorption: A novel strategy for achieving glucose control in type 2 diabetes mellitus. Endocrine Practice. 2008;14(6):782-90.
6Woerle HJ, Ferrannini E, Berk A, Manun'Ebo M, Pinnetti S, Broedl UC. 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. 72nd Scientific Sessions of the American Diabetes Association. Philadelphia, Pennsylvania, USA, June 2012.
7International Diabetes Federation. The Global Burden. IDF Diabetes Atlas. 2011(5th Edition).
8World Health Organization. Fact Sheet No. 312 What is Diabetes?, 2010
9International Diabetes Federation. What is Diabetes? . IDF Diabetes Atlas. 2011(5th Edition).
*Empagliflozin is an investigational compound. Its safety and efficacy have not yet been fully established