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.
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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
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Title |
Format |
Authors |
Presentation details |
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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. |
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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. |
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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. |
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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. |
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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. |
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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. |
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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. |
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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. |
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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 |
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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 |
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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 |
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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. |
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BI-10773 Data
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Title |
Format |
Authors |
Presentation details |
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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. |
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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. |
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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 |
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Health Economics and Outcomes Research Data (HEOR)
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Title |
Format |
Authors |
Presentation details |
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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. |
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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 |
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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