Boehringer Ingelheim and Lilly to Feature Type 2 Diabetes Research in More Than 25 Presentations at the 71st American Diabetes A

Late-breaking, two-year cardiovascular data to be presented for DPP-4 inhibitor linagliptin

RIDGEFIELD, Conn. and INDIANAPOLIS, June 20, 2011 /PRNewswire/ -- Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) will present the latest data from their diabetes portfolio at the 71st American Diabetes Association (ADA) Scientific Sessions in San Diego on June 24-28. Study results evaluating the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin, as well as the investigational sodium glucose cotransporter−2 (SGLT−2) inhibitor BI-10773, will be featured among the 27 presentations. Linagliptin, 5 mg, is marketed under the trade name Tradjenta™ (linagliptin) tablets in the U.S. and was approved by the U.S. Food and Drug Administration (FDA) in May 2011 to be used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.  TRADJENTA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis (increased ketones in the blood or urine). It has not been studied in combination with insulin.

To view the multimedia assets associated with this release, please click: http://multivu.prnewswire.com/mnr/boehringer-ingelheim/50750/

Two linagliptin abstracts were selected by ADA as President's Posters, a prestigious session showcasing 100 specially-selected posters on Sunday, June 26 and repeated on Monday, June 27.  Two additional Phase III studies evaluating cardiovascular events will be highlighted as late-breaking posters.

Among the presentations are the following:

Linagliptin Data


Title

Format

Authors

Presentation details

Phase III (12-week)

Safety and Efficacy of Linagliptin in Type 2 Diabetes Patients with Severe Renal Impairment

President's Poster

413-PP

L Sloan, J Newman, C Sauce, M von Eynatten, S Patel, H-J Woerle

President's Poster Reception

Date: Sun, June 26

Time: 6:45−8 p.m.

President's Poster Session

Date: Mon, June 27

Time: 12-2 p.m.

Phase III (pooled analysis)

Efficacy and Safety of Linagliptin in Patients with Type 2 Diabetes with or without Renal Impairment: Results From a Global Phase III Program

Poster

1068-P

M Cooper, M von Eynatten, A Emser, S Patel, H-J Woerle

Date: Sat, June 25

Time: 11:30 a.m.-1:30 p.m.

Phase III (24-week)

Combination of Linagliptin and Metformin Improves Glycemic Control in Type 2 Diabetes: A Randomized Trial with an Open-Label Arm in Patients with Poor Glycemic Control

Oral

279-OR

T Haak, T Meinicke, R Jones, M von Eynatten, H-J Woerle

Date: Mon, June 27

Time: 8-10 a.m.


Phase III (2-year)

Linagliptin has Improved Safety and Similar Efficacy to Glimepiride over 2 Years in Patients with Type 2 Diabetes Mellitus Inadequately Controlled on Metformin

Late-Breaking  Poster

39-LB

B Gallwitz, B Uhlig-Laske, S Battacharaya, S Patel, H-J Woerle

Date: Sun, June 26

Time: 12-2 p.m.

Phase III (meta-analysis)

Cardiovascular Risk with Linagliptin in Patients with Type 2 Diabetes: A Pre-specified, Prospective, and Adjudicated Meta-Analysis from a Large Phase III Program

Late-Breaking Poster

30-LB


O-E Johansen, D Neubacher, M von Eynatten, S Patel, H-J Woerle

Date: Sun, June 26

Time: 12-2 p.m.

Phase III (pooled analysis)

Efficacy and Safety of Linagliptin in Patients with Type 2 Diabetes and Poor Glycemic Control

Poster

1067-P

S Del Prato, M-R Taskinen, D Owens, M von Eynatten, A Emser, S Patel, H-J Woerle

Date: Sat, June 25

Time: 11:30 a.m.-1:30 p.m.

Phase III (pooled analysis)

Renal Impairment has no Relevant Effect on Long−Term Exposure of Linagliptin in Patients with Type 2 Diabetes

Poster

1105-P

C Friedrich, A Emser, H-J Woerle,

U Graefe-Mody

Date: Sat, June 25

Time: 11:30 a.m.-1:30 p.m.

Phase III

The Rationale and Design of the CAROLINA trial: An Active Comparator CARdiOvascular Outcome Study of the DPP-4 Inhibitor Linagliptin in Patients with Type 2 Diabetes at High Cardiovascular Risk

Poster

1103-P

J Rosenstock, N Marx, SE Kahn, B Zinman, J Kastelein, J Lachin, E Bluhmki, A Schlosser, D Neubacher, S Patel, O-E Johansen, H-J Woerle

Date: Sat, June 25

Time: 11:30 a.m.-1:30 p.m.

Phase III (pooled analysis)

Efficacy and Safety of Linagliptin in Type 2 Diabetes Patients at High Risk of Renal Complications: Results From a Large Phase III Program

Publication only

2274-PO

P-H Groop, M von Eynatten,  A Emser, S Patel, H-J Woerle

N/A


Phase III (pooled analysis)

Safety and Tolerability of Linagliptin: A Pooled Analysis of Data from 3572 Patients with Type 2 Diabetes

Publication  only

2327-PO

G Schernthaner, M von Eynatten, A Emser, H-J Woerle

N/A

Phase III (pooled analysis)

The Novel DPP-4 Inhibitor Linagliptin is Associated with a Very Low Risk of Hypoglycemia: Results from a Large Phase III Program

Publication only

2346-PO

A-H Barnett, AA Tahrani, M von Eynatten, A Emser, S Patel, H-J Woerle

N/A


Preclinical

The DPP-4 Inhibitor Linagliptin Reduces Intra-myocellular and Hepatic Lipid Accumulation in a Diet-induced Obesity Rat Model: An MRS-based Study in Comparison to Sibutramine

President's Poster

415-PP

T Klein, R Grempler, E Mayoux, H Niessen, S Cheetham, D Stiller, M Mark

President's Poster Reception

Date: Sun, June 26

Time: 6:45-8 p.m.

President's Poster Session

Date: Mon, June 27

Time: 12-2 p.m.




BI-10773 Data


Title

Format

Authors

Presentation details

Phase II

Efficacy and Safety of BI-10773, a New Sodium Glucose Cotransporter-2 (SGLT-2) Inhibitor, in Type 2 Diabetes Inadequately Controlled on Metformin

Moderated poster

989-P

J Rosenstock, A Jelaska, L Seman, S Pinnetti, S Hantel, H-J Woerle

General poster session

Date: Sat, June 25

Time: 11:30 a.m.-1:30 p.m.

Guided audio poster tour

Date: Sun, June 26

Time: 12-1 p.m.

Phase I/II

Evaluation of Efficacy and Tolerability Using Exposure-Response Modeling for BI-10773, a Sodium Glucose Cotransporter-2 (SGLT-2) Inhibitor, in Patients with Type 2 Diabetes

Poster

1069-P

M Riggs, S Macha, L Seman, A Staab, T MacGregor, H-J Woerle, W Gillispie, M Gastonguay

Date: Sat, June 25

Time: 11:30 a.m.-1:30 p.m.

Phase I

Pharmacokinetics and Pharmacodynamics of BI-10773, a Sodium Glucose Cotransporter-2 (SGLT-2) Inhibitor, and Linagliptin, a Dipeptidyl Peptidase-4 (DPP-4) Inhibitor, Following Co-Administration in Healthy Volunteers

Publication only

2318-PO

C Friedrich, K Metzmann, P Rose, M Mattheus, S Pinnetti, H-J Woerle

N/A




Health Economics and Outcomes Research Data (HEOR)


Title

Format

Authors

Presentation details

US – HEOR

Clinical and Economic Outcomes of Appropriate Oral Antidiabetic Drug (OAD) Treatment Among Type 2 Diabetes Mellitus (T2DM) Patients with Chronic Kidney Disease (CKD)

Late- Breaking Poster 52-LB

S-Y Chen, B Kovacs, M Stokes, S Sander, K Siu, P Rao, L Boulanger

Date: Sun, June 26

Time: 12-2 p.m.

US - HEOR

Insulin Use, its Associated Costs, Glycemic Control and Hypoglycemia in Patients with Type 2 Diabetes Mellitus and Renal Impairment

Publication only

2107-PO


J Burke, K Siu, B Kovacs, L Borton, S Sander

N/A




To learn more about TRADJENTA and for full prescribing information visit: www.TRADJENTA.com or call Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257.

Please report any unexpected effects or product problems to the Boehringer Ingelheim Drug Information Unit by calling 1-800-542-6257.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Indication and Important Limitations of Use

TRADJENTA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

TRADJENTA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.

TRADJENTA has not been studied in combination with insulin.

Important Safety Information

CONTRAINDICATIONS

TRADJENTA is contraindicated in patients with a history of hypersensitivity reaction to linagliptin, such as urticaria, angioedema or bronchial hyperreactivity.

WARNINGS AND PRECAUTIONS

Use with Medications Known to Cause Hypoglycemia

Insulin secretagogues (e.g., sulfonylurea) are known to cause hypoglycemia. Therefore, a lower dose of the insulin secretagogue may be required to reduce the risk of hypoglycemia when used in combination with TRADJENTA.

Macrovascular Outcomes

There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with TRADJENTA or any other antidiabetic drug.

ADVERSE REACTIONS

Adverse reactions reported in >/= 5% of patients treated with TRADJENTA and more commonly than in patients treated with placebo included nasopharyngitis.

Hypoglycemia was more commonly reported in patients treated with the combination of TRADJENTA and sulfonylurea compared with those treated with the combination of placebo and sulfonylurea. Pancreatitis was reported more often in patients randomized to linagliptin (1 per 538 person-years versus zero in 433 person-years for comparator).

DRUG INTERACTIONS

The efficacy of TRADJENTA may be reduced when administered in combination with a strong P-glycoprotein or CYP3A4 inducer (e.g., rifampin). Therefore, use of alternative treatments is strongly recommended.

USE IN SPECIFIC POPULATIONS

There are no adequate and well-controlled studies in pregnant women. Therefore, TRADJENTA should be used during pregnancy only if clearly needed. It is not known whether linagliptin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when TRADJENTA is administered to a nursing woman. Safety and effectiveness of TRADJENTA in patients below the age of 18 have not been established.

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 Pharmaceuticals, Inc.

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 145 affiliates and more than 42,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products 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 2010, Boehringer Ingelheim posted net sales of approximately $16.7 billion (about 12.6 billion euro) while spending almost 24 percent of net sales in its largest business segment, Prescription Medicines, on research and development.

For more information, please visit http://us.boehringer-ingelheim.com and follow us on Twitter at http://twitter.com/boehringerus.

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

For more than 85 years, Lilly has been a worldwide leader in pioneering industry-leading solutions to support people living with and treating diabetes. Lilly introduced the world's first commercial insulin in 1923, and remains at the forefront of medical and delivery device innovation to manage diabetes. Lilly is also committed to providing solutions beyond therapy – practical tools, education, and support programs to help overcome barriers to success along the diabetes journey. At Lilly, the journeys of each person living with or treating diabetes inspire ours. For more information, visit www.lillydiabetes.com.

This press release contains forward-looking statements about TRADJENTA or 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 TRADJENTA will 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.

P-LLY

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.; Eli Lilly and Company

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