The Alliance continues to reinforce its commitment to diabetes with data presentations on three molecules in three product classes, across type 1 and type 2 diabetes
RIDGEFIELD, Conn. and INDIANAPOLIS, Sept. 24, 2012 /PRNewswire/ -- Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) will present data for three molecules, including two investigational compounds, from their Diabetes Alliance portfolio at the 48th European Association for the Study of Diabetes (EASD) Annual Meeting in Berlin, 1–5 October 2012. Now in its second year, the Boehringer Ingelheim and Lilly Diabetes Alliance continues its commitment to address patient needs arising from the growing global diabetes pandemic. Its portfolio of compounds represents several of the largest product classes for the treatment of diabetes.
New data for linagliptin, the dipeptidyl peptidase-4 (DPP-4) inhibitor will be presented. Recent data are available for the investigational inhibitor of the sodium glucose co-transporter-2 (SGLT-2), empagliflozin* for type 2 diabetes and the investigational novel basal insulin analog, LY2605541*, both of which are in late-stage clinical development.
Abstract highlights include:
- Linagliptin: Results from a large, phase III, 52-week study (n= 1,261), evaluating the safety and efficacy of linagliptin or placebo added on to basal insulin in patients inadequately controlled on basal insulin therapy, and three pooled analyses of phase III data in populations of patients with type 2 diabetes.
- Empagliflozin*: Phase IIb data among 903 patients with type 2 diabetes, including effects on HbA1c, blood pressure and weight, for the investigational sodium glucose co-transporter−2 (SGLT-2) inhibitor.
- Novel basal insulin analog, LY2605541*: Pre-clinical, Phase I (n=78) and Phase II (n=425) clinical trial data assessing the effects of the novel basal insulin analog, LY2605541, on glycemic control and other measures in patients with type 1 diabetes and type 2 diabetes.
Clinical and preclinical abstracts on linagliptin will be presented at the meeting. Details of select presentations are as follows:
- Tuesday , October 2, 10:45 AM - 12:15 PM, Oral Session: 01 Incretin based therapies
- Long-term safety and efficacy of linagliptin as add-on therapy to basal insulin in patients with type 2 diabetes: a 52-week randomized, placebo-controlled trial (Lead Author: H Yki-Jarvinen) [Langerhans Hall, Presentation No. 6]
- Tuesday , October 2, 10:45 AM - 12:15 PM, Oral Session: 06 What's new in the treatment of diabetic nephropathy?
- Effects of the DPP-4 inhibitor linagliptin on albuminuria in patients with type 2 diabetes and diabetic nephropathy (Lead Author: P.-H. Groop) [Rubner Hall, Presentation No. 36]
- Tuesday, October 2, 2012, 12:30 PM - 1:30 PM, General Poster Session: 067 DPP-4 inhibitors
- Safety and efficacy of linagliptin plus basal insulin combination therapy in a vulnerable population of elderly patients (aged greater than or equal to 70 years) with type 2 diabetes (Lead Author: HJ Woerle) [Poster No. 848]
- Safety and efficacy of linagliptin in elderly patients with type 2 diabetes: evidence from 1331 individuals aged greater than or equal to 65 years (Lead Author: S Patel) [Poster No. 850]
Linagliptin, which is marketed as Tradjenta® 5mg tablets in the U.S., is a once-daily tablet that is used along with diet and exercise to improve glycemic control in adults with type 2 diabetes. 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). Linagliptin is a DPP-4 inhibitor that does not require dose adjustments, regardless of declining renal function or hepatic impairment.
Clinical data will be presented on empagliflozin. Details on this presentation are as follows:
- Thursday, October 4, 2012, 12:00 PM - 1:00 PM, General Poster Session: 059 SGLT-2 IV
- The sodium glucose cotransporter-2 (SGLT-2) inhibitor empagliflozin lowers blood pressure independent of weight or HbA1c changes (Lead Author: T Hach) [Poster No. 770]
Novel Basal Insulin Analog (LY2605541)* Data
Details of select presentations for LY2605541 are as follows:
- Tuesday, October 2, 2012, 10:45 AM - 12:15 PM, Oral Session: 04 Insulin Action in the Liver
- Novel PEGylated basal insulin LY2605541 has a preferential hepatic effect on glucose metabolism (Lead Author: MC Moore) [Heubner Hall, Presentation: 24]
- Tuesday, October 2, 2012, 3:00 PM - 4:30 PM, General Poster Session: 07 What's New in Insulin Therapy?
- LY2605541: Leveraging hydrodynamic size to develop a novel basal insulin (Lead Author: JM Beals) [Langerhans Hall, Presentation: 42]
- Thursday, October 4, 2012, 1:15 PM - 2:15 PM, General Poster Session: 078 Psychological Aspects I
- Novel long-acting basal insulin analog LY2605541 significantly reduces nocturnal hypoglycemia and fear of hypoglycemia compared to insulin glargine in patients with type 2 diabetes mellitus (Lead Author: B Curtis) [Poster No. 954]
*Empagliflozin and novel basal insulin analog LY2605541 are investigational compounds. Their safety and efficacy have not yet been fully established.
What are Tradjenta® (linagliptin) tablets?
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).
Important Safety Information
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 are rash, raised red patches on your skin (hives), swelling of your face, lips, 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 right away.
What should I tell my doctor before taking TRADJENTA?
Tell your doctor if you take other medicines that can lower your blood sugar, such as a sulfonylurea or insulin.
TRADJENTA may cause serious side effects, including low blood sugar (hypoglycemia). 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.
Signs and symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, or feeling jittery.
Also tell your doctor if you take rifampin (Rifadin®, Rimactane®, Rifater®, Rifamate®), an antibiotic that is used to treat tuberculosis.
TRADJENTA may affect the way other medicines work, and other medicines may affect how TRADJENTA works.
Tell your doctor if you are pregnant or planning to become pregnant or are breastfeeding or plan to breastfeed.
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
What are the possible side effects of TRADJENTA?
The most common side effects of TRADJENTA include stuffy or runny nose and sore throat.
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.
For more safety information, please see Patient Information and full Prescribing Information.
TJ CONS ISI August 14 2012
To learn more about TRADJENTA visit: www.TRADJENTA.com. For full prescribing information visit: http://bidocs.boehringer-ingelheim.com/BIWebAccess/ViewServlet.ser?docBase=renetnt&folderPath=/Prescribing+Information/PIs/Tradjenta/Tradjenta.pdf 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.
Approximately 25.8 million Americans1 and an estimated 366 million people worldwide2 have type 1 or type 2 diabetes. Type 2 diabetes is the most common type, accounting for an estimated 90 to 95 percent of all diabetes cases.1 Diabetes is a chronic disease that occurs when the body either does not properly produce, or use, the hormone insulin.3
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 $17.1 billion (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 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
Lilly has been a global leader in diabetes care since 1923, when Lilly introduced the world's first commercial insulin. Today Lilly works 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 Tradjenta tablets and two investigational compounds, empagliflozin* and novel basal insulin LY2605541*, which are currently in development for the treatment of 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, that empagliflozin* and novel basal insulin LY2605541* will receive required regulatory approvals, 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.
1. Centers for Disease Control and Prevention. National Diabetes Fact Sheet: National Estimates and General Information on Diabetes and Prediabetes in the United States, 2011. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention. 2011.
2. International Diabetes Federation. Diabetes Atlas, 5th Edition: Fact Sheet. 2011.
3. International Diabetes Federation. IDF Diabetes Atlas, 5th Edition: What is Diabetes? http://www.idf.org/diabetesatlas/5e/what-is-diabetes. Accessed on: April 11, 2012.
SOURCE Eli Lilly and Company; Boehringer Ingelheim