New publication in The Lancet: Two-year study in over 1,500 patients compares Trajenta (linagliptin) to the commonly prescribed sulphonylurea glimepiride

INGELHEIM, Germany - Thursday, June 28th 2012 [ME NewsWire]

Linagliptin provides similar glucose improvements but with less hypoglycaemia and relative weight loss when compared to glimepiride in patients with Type 2 Diabetes

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Results from a two-year study published in The Lancet today demonstrate that Trajenta® (linagliptin) provides similar blood glucose improvements when compared to the commonly prescribed sulphonylurea, glimepiride, in adult patients with Type 2 Diabetes (T2D) inadequately controlled on metformin alone. The publication also describes that linagliptin was associated with significantly fewer hypoglycaemic events and resulted in relative weight loss of 2.7 kg compared to glimepiride.1

The publication reports on a two-year, randomised, double-blind study in 1,552 patients evaluating the efficacy of linagliptin compared to glimepiride as measured by a reduction in HbA1c from baseline in patients uncontrolled on metformin alone.1

“These study results are interesting to the medical community because of the main study objective which was to compare the glycaemic control achieved by linagliptin and glimepiride,” Professor Baptist Gallwitz, Professor of Medicine, Eberhard Karls University, Tübingen, Germany. “The safety evaluation is interesting; and, although based on a small number of cardiovascular events (n=38), we were able to evaluate and compare the incidences of major cardiovascular events between linagliptin and glimepiride for the first time.”

The profile of linagliptin vs. glimepiride is being further investigated in the ongoing, head-to-head outcomes trial CAROLINA - the first outcomes study to compare a DPP-4 inhibitor with an active comparator. The study investigates 6,000 patients over a five year period and patient recruitment is due to complete this year.2

Linagliptin (5 mg, once daily) is marketed in the U.S. as Tradjenta® (linagliptin) tablets, in Europe as Trajenta™ (linagliptin) tablets, and in other global markets as a once-daily tablet that is used along with diet and exercise to improve glycaemic control in adults with T2D. Linagliptin should not be used in patients with Type 1 Diabetes or for the treatment of diabetic ketoacidosis (increased ketones in the blood or urine). With linagliptin, no dose adjustment is required regardless of declining renal function or hepatic impairment.3,4

-Ends-

About Diabetes

An estimated 366 million people worldwide have Type 1 and Type 2 Diabetes.5 Type 2 Diabetes is the most common type, accounting for an estimated 90 to 95% of all diabetes cases.6 Diabetes is a chronic disease that occurs when the body either does not properly produce, or use, the hormone insulin.7

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 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 linagliptin 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 linagliptin 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.

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References

1 Gallwitz, B., Rosenstock J., Rauch, T., et al. Two-year efficacy and safety of linagliptin compared with glimepiride in patients with Type 2 Diabetes inadequately controlled on metformin: A randomised, double-blind, active controlled, non-inferiority trial. Lancet. 2012 June 28. [E-publication ahead of print].http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(12)60691-6/fulltext Accessed on: June 28, 2012.

2 Clinical Trials: CAROLINA: Cardiovascular Outcome Study of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes.

3 Trajenta™ (linagliptin) tablets. EMA Summary of Product Characteristics. Approval 25 September 2011.

4 Tradjenta™ (linagliptin) tablets. Highlights of Prescribing Information. Initial U.S. Approval: 2011.

5 International Diabetes Federation. IDF Diabetes Atlas, 5th Edition: The Global Burden http://www.idf.org/diabetesatlas/5e/the-global-burden. Accessed on: June 21, 2012.

6 International Diabetes Federation. IDF Diabetes Atlas, 5th Edition: Diabetes http://www.idf.org/diabetesatlas/5e/diabetes. Accessed on: June 21, 2012.

7 International Diabetes Federation. IDF Diabetes Atlas, 5th Edition: What is Diabetes? http://www.idf.org/diabetesatlas/5e/what-is-diabetes. Accessed on: June 21, 2012.

Contacts

Boehringer Ingelheim GmbH

Ute E Schmidt

Director Diabetes Franchise

Email: press@boehringer-ingelheim.com

Phone: +49 (6132) 77-97296



Lilly Diabetes

Tammy Hull

Communications Manager

Email: hullta@lilly.com

Phone: (317) 651-9116