Boehringer Ingelheim and Lilly Diabetes Alliance to Present Data from 35 Studies at the American Diabetes Association's 75th Scientific Sessions®
Clinical and pre-clinical data on compounds representing several of the largest diabetes treatment classes will be presented
"With growing numbers of people being diagnosed with diabetes, there is tremendous need for ongoing clinical research to ensure treatment options and approaches are available to meet patients' diverse needs," said Thomas Seck , M.D., vice president, Clinical Development and Medical Affairs - Metabolism at Boehringer Ingelheim. "As part of our commitment to the diabetes community, the BI-Lilly Diabetes alliance will present an array of product, disease state and patient-physician survey data that help address the needs of adults with diabetes."
Highlighted presentations and posters include:
Empagliflozin/Metformin Data
- Initial Combinations of Empagliflozin and Metformin (EMPA+MET) in Patients with Type 2 Diabetes (T2DM) (Presenting Author: Hadjadj, S.) [119-LB]
Empagliflozin plus immediate-release metformin hydrochloride fixed-dose combination is an investigational compound being studied for the treatment of adults with T2D. Data on this combination will be discussed in a late-breaker poster presentation.
IntroDia™ Survey Data
- Physician-Patient Communication At Prescription of an Additional Oral Agent for Type 2 Diabetes (T2D): Link Between Key Conversation Elements, Physician Empathy and Patient Outcomes - Insights From the Global IntroDia™ Study (Presenting Author: Capehorn, M.) [63-LB]
IntroDia™ is the largest global patient and physician survey ever conducted that focuses on early conversations about T2D - providing insights into how physicians and patients interact at important moments of the diabetes treatment journey. New results from the survey will be presented as a late-breaker poster presentation.
Tradjenta® (linagliptin) Data
- Safety and Efficacy of Linagliptin in Patients with Type 2 Diabetes (T2D) and Coronary Artery Disease (CAD): Analysis Of Pooled Incident Investigator Reported Events From Phase 3 Clinical Trials (Presenting Author: Leiter, L.) [1246-P]
Linagliptin, marketed as Tradjenta® (linagliptin) 5 mg tablets in the U.S., is a DPP-4 inhibitor, which works by increasing hormones that stimulate the pancreas to produce more insulin and stimulate the liver to produce less glucose. Data will be presented as a poster presentation.
A complete list of alliance abstracts to be presented or published at the 75th ADA Scientific Sessions can be found here.
About Diabetes
Approximately 29 million Americans and an estimated 387 million people worldwide have type 1 or type 2 diabetes, and nearly 28 percent of Americans with diabetes—totaling 8 million people—are undiagnosed. In the U.S., approximately 12 percent of those aged 20 and older have diabetes. T2D is the most common type, accounting for an estimated 90 to 95 percent of all diagnosed adult diabetes cases in the U.S. Diabetes is a chronic condition that occurs when the body either does not properly produce, or use, the hormone insulin.
What is TRADJENTA?
TRADJENTA is a prescription medicine that is used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
TRADJENTA is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).
If you have had inflammation of the pancreas (pancreatitis) in the past, it is not known if you have a higher chance of getting pancreatitis while you take TRADJENTA.
IMPORTANT SAFETY INFORMATION
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about TRADJENTA?
Serious side effects can happen to people taking TRADJENTA, including inflammation of the pancreas (pancreatitis), which may be severe and lead to death. Before you start taking TRADJENTA, tell your doctor if you have ever had pancreatitis, gallstones, a history of alcoholism, or high triglyceride levels.
Stop taking TRADJENTA and call your doctor right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.
Who should not take TRADJENTA?
Do not take TRADJENTA if you are allergic to linagliptin or any of the ingredients in TRADJENTA.
Symptoms of a serious allergic reaction to TRADJENTA may include rash, itching, flaking or peeling; raised red patches on your skin (hives); swelling of your face, lips, tongue and throat that may cause difficulty breathing or swallowing. If you have any symptoms of a serious allergic reaction, stop taking TRADJENTA and call your doctor or go to the emergency room right away.
What should I tell my doctor before using TRADJENTA?
Tell your doctor about all your medical conditions, including if you have or have had inflammation of your pancreas (pancreatitis).
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. TRADJENTA may affect the way other medicines work, and other medicines may affect how TRADJENTA works.
Especially tell your doctor if you take
- other medicines that can lower your blood sugar. If you take TRADJENTA with another medicine that can cause low blood sugar, such as sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea or insulin may need to be lowered while you take TRADJENTA.
- rifampin (Rifadin®, Rimactane®, Rifater®, Rifamate®), an antibiotic that is used to treat tuberculosis.
Tell your doctor if you are pregnant or planning to become pregnant or are breastfeeding or plan to breastfeed.
What are the possible side effects of TRADJENTA?
TRADJENTA may cause serious side effects, including
- Inflammation of the pancreas (pancreatitis).
- Low blood sugar (hypoglycemia), especially if you take TRADJENTA with another medicine that can cause low blood sugar. Signs and symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, or feeling jittery.
- Allergic (hypersensitivity) reactions can happen after your first dose or up to 3 months after starting TRADJENTA. Symptoms may include swelling of your face, lips, throat, and other areas on your skin; difficulty with swallowing or breathing; raised, red areas on your skin (hives); skin rash, itching, flaking, or peeling.
The most common side effects of TRADJENTA include stuffy or runny nose, sore throat, cough and diarrhea.
These are not all the possible side effects of TRADJENTA. For more information, ask your doctor or pharmacist. You are encouraged to report negative side effects of prescription drugs to the FDA . Visit www.fda.gov/medwatchor call 1-800-FDA -1088.
TJ CONS ISI 28MAY2014
Click here for full Prescribing Information, including Medication Guide.
^The brands listed are trademarks of their respective owners and are not trademarks of Boehringer Ingelheim Pharmaceuticals, Inc. The makers of these brands are not affiliated with and do not endorse Boehringer Ingelheim Pharmaceuticals, Inc. , or its products.
To learn more about TRADJENTA visit: www.TRADJENTA.com. For full Prescribing Information and Medication Guide visit: http://bidocs.boehringer-ingelheim.com/BIWebAccess/ViewServlet.ser?docBase=renetnt&folderPath=/Prescribing+Information/PIs/Tradjenta/Tradjenta.pdf.
Please report any unexpected effects or product problems to the Boehringer Ingelheim Drug Information Unit by calling 1-800-542-6257.
Boehringer Ingelheim and Eli Lilly and Company
In January 2011 , Boehringer Ingelheim and Eli Lilly and Company announced an alliance in diabetes that centers on compounds representing several of the largest diabetes treatment classes. This alliance leverages the strengths of two of the world's leading pharmaceutical companies. 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
Boehringer Ingelheim is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany , the company operates globally with 146 affiliates and more than 47,000 employees. Since its founding in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel treatments for human and veterinary medicine.
Boehringer Ingelheim is committed to improving lives and providing valuable services and support to patients and families. Our employees create and engage in programs that strengthen our communities. To learn more about how we make more health for more people, visit our Corporate Social Responsibility Report.
In 2014, Boehringer Ingelheim achieved net sales of about $16.96 billion dollars (13.3 billion euros). R&D expenditure corresponds to 19.9 percent of its net sales.
For more information please visit www.us.boehringer-ingelheim.com, or follow us on Twitter @BoehringerUS.
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 are building upon this heritage by working to meet the diverse needs of people with diabetes and those who care for them. Through research and collaboration, a broad and growing product portfolio and a continued determination to provide real solutions—from medicines to support programs and more—we strive to make life better for all those affected by diabetes around the world. For more information, visit www.lillydiabetes.com.
About Eli Lilly and Company
Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and newsroom.lilly.com/social-channels.
This press release contains forward looking statements about TRADJENTA and the investigational fixed-dose combination of empagliflozin and metformin for the treatment of type 2 diabetes along with diet and exercise. 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, that the investigational fixed-dose combination of empagliflozin and metformin will be approved or be commercially successful, or that TRADJENTA will receive additional regulatory approvals. 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 . Except as required by law, Lilly undertakes no duty to update forward-looking statements.
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