Boehringer Ingelheim and Lilly introduce the My Well Planner Lifestyle Improvement Program for Adults with Type 2 Diabetes The new, personalized online resource designed for adult patients with type 2 diabetes to set and reach their health goals is from the makers of Tradjenta® (linagliptin) and Jentadueto® (linagliptin/metformin hydrochloride) tablets

RIDGEFIELD, Conn. and INDIANAPOLIS, Sept. 13, 2012 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company (NYSE: LLY) today announce the availability of a new online program offering customized educational content to help adults with type 2 diabetes make simple lifestyle changes to improve their health. My Well Planner is designed to address the emotional barriers people with type 2 diabetes face every day, going beyond education to help them, working with their healthcare providers, set achievable goals based on their personal needs.

My Well Planner is a free, comprehensive resource open to adults with type 2 diabetes. Modeled on a behavioral change approach, it offers personalized content that adjusts as patients use the tool over time. The program helps adults with type 2 diabetes and their healthcare providers work together to set small lifestyle goals at their own pace, building toward bigger goals in the future. Sample topics include: general information about type 2 diabetes, better eating habits, building physical activity into daily life, taking medication and communication strategies.

"Managing type 2 diabetes is complex. While medication is important, maintaining healthy diet and exercise habits are critical as well in order to successfully control blood glucose levels," said Francine Cabrera, RN, CDE, WOCN, Philadelphia, Penn. "It is not easy to break old habits and create healthier ones. What sets My Well Planner apart is its personalized content based on a graduated approach to help patients build goals and confidence to make healthy life changes."

Approximately 25.8 million Americans, or 8.3 percent, 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 The Centers for Disease Control and Prevention (CDC) projects as many as one in three U.S. adults could have diabetes by 2050 if current trends continue.2 However, research has shown for patients with diabetes, a combination of treatment and lifestyle changes in nutrition, physical exercise and stress reduction can bring about improvements in their glucose levels.1

Once enrolled in the My Well Planner program, patients are asked to take a self assessment to determine their motivation levels. Unlike other programs, My Well Planner delivers tailored tips based on patients' evaluation results to help them take an active role in their condition and maintain healthy behaviors over time. The program also creates progress reports, which patients can print out and take to their healthcare providers to discuss during visits.

"There is no one-size-fits-all approach to managing type 2 diabetes. The Boehringer Ingelheim and Lilly Diabetes Alliance is committed to helping the millions of Americans living with type 2 diabetes manage their health by providing resources, such as My Well Planner, as well as treatments, such as the TRADJENTA and JENTADUETO family of products," said David Pass, PharmD, vice president, metabolism marketing, Boehringer Ingelheim Pharmaceuticals, Inc.

People with type 2 diabetes can register and create their own My Well Planner account at www.mywellplannerinfo.com.

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 (linagliptin)?

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 (linagliptin)?

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 (linagliptin)?

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® (linagliptin) tablets 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.

What is Jentadueto® (linagliptin/metformin hydrochloride) tablets?

JENTADUETO is a prescription medicine that contains two diabetes medicines, linagliptin and metformin. JENTADUETO can be used along with diet and exercise to help control blood sugar in adults with type 2 diabetes when treatment with both linagliptin and metformin is appropriate.

JENTADUETO is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).

It is not known if JENTADUETO is safe and effective when used with insulin.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about JENTADUETO (linagliptin/metformin hydrochloride)?

WARNING: RISK OF LACTIC ACIDOSIS

Serious side effects can happen in people taking JENTADUETO. Metformin, one of the medicines in JENTADUETO, can cause a rare but serious condition called lactic acidosis (a build-up of lactic acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in a hospital.

 

Stop taking JENTADUETO and call your doctor right away if you feel very weak or tired, have unusual muscle pain, have trouble breathing, are very sleepy, have sudden nausea and vomiting or diarrhea, feel cold, especially in your arms or legs, feel dizzy or lightheaded, or have a slow or irregular heartbeat, as these could be symptoms of lactic acidosis.

 

You have a higher chance of getting lactic acidosis with JENTADUETO if you have kidney problems, liver problems, congestive heart failure that requires medicines, drink alcohol very often, or drink a lot of alcohol in short-term "binge" drinking, get dehydrated (lose a large amount of body fluids), have certain x-ray tests with dyes or contrast agents that are injected into your body, have surgery, have a heart attack, severe infection, or stroke, and are 80 years of age or older and have not had your kidneys tested.

 

Who should not take Jentadueto® (linagliptin/metformin hydrochloride) tablets?

Do not take JENTADUETO if you:

  • have kidney problems
  • have a condition called metabolic acidosis or diabetic ketoacidosis (increased ketones in the blood or urine)
  • are allergic to linagliptin, metformin or any of the ingredients in JENTADUETO. Symptoms of any allergic reaction are rash, raised red patches on your skin (hives), and 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 JENTADUETO and call your doctor right away.

What should I tell my doctor before using JENTADUETO (linagliptin/metformin hydrochloride)?

Before you take JENTADUETO, tell your doctor if you:

  • have kidney problems
  • are going to get an injection of dye or contrast agents for an x-ray procedure. JENTADUETO will need to be stopped for a short time. Talk to your doctor about when you should stop JENTADUETO and when you should start JENTADUETO again.
  • have liver problems
  • have heart problems, including congestive heart failure
  • drink alcohol very often, or drink a lot of alcohol in short term "binge" drinking
  • have any other medical conditions
  • are pregnant or planning to become pregnant. It is not known if JENTADUETO will harm your unborn baby. If you are pregnant, talk with your doctor about the best way to control your blood sugar while you are pregnant.
  • are breast-feeding or plan to breast-feed. It is not known if JENTADUETO passes into your breast milk. Talk with your doctor about the best way to feed your baby if you take JENTADUETO.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. JENTADUETO may affect the way other medicines work, and other medicines may affect how JENTADUETO works.

Especially tell your doctor if you take:

  • other medicines that can lower your blood sugar. JENTADUETO may cause serious side effects, including low blood sugar (hypoglycemia), which may become worse in people who already take another medication to treat diabetes, such as a sulfonylurea or insulin. Tell your healthcare provider if you take other diabetes medicines. Your doctor may prescribe lower doses of the sulfonylurea medicine.

If you have symptoms of low blood sugar, you should check your blood sugar and treat it if it is low, then call your healthcare provider. Symptoms of low blood sugar include shaking, rapid heartbeat, hunger, headache, sweating, change in vision, and change in mood.

  • rifampin (Rifadine®, Rimactane®, Rifater®, Rifamate®), an antibiotic that is used to treat tuberculosis.

Ask your doctor or pharmacist for a list of these medicines if you are not sure if your medicine is one that is listed above.

Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.

What are the possible side effects of JENTADUETO (linagliptin/metformin hydrochloride) tablets?

The most common side effects of JENTADUETO include:

  • stuffy or runny nose and sore throat
  • diarrhea

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

Please see Important Safety Information including Boxed Warning about the Risk of Lactic Acidosis, and full Prescribing Information, including Patient Information for additional safety information.

To learn more about JENTADUETO (linagliptin/metformin hydrochloride) tablets visit http://www.JENTADUETO.com. For full prescribing information visit http://bidocs.boehringer-ingelheim.com/BIWebAccess/ViewServlet.ser?docBase=renetnt&folderPath=/Prescribing+Information/PIs/Jentadueto/Jentadueto.pdf or call Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257, or (TTY) 1-800-459-9906.

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

About Diabetes

Approximately 25.8 million Americans1 and an estimated 366 million people worldwide3 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.4

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.

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

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.

P-LLY

TJ434300

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, Center for Disease Control and Prevention, 2011.

2 Boyle JP, Thompson TJ, Gregg EW, et al. Projection of the year 2050 burden of diabetes in the US adult population: dynamic modeling of incidence, mortality, and prediabetes prevalence. Popul Health Metr. 2010:8:29. doi: 10.1186/1478-7954-8-29

3 International Diabetes Federation. Diabetes Atlas, 5th Edition: Fact Sheet. 2011.

4 International Diabetes Federation. IDF Diabetes Atlas, 5th Edition: What is Diabetes? http://www.idf.org/diabetesatlas/5e/what-is-diabetes. Accessed on: July 27, 2012.

(Logo: http://photos.prnewswire.com/prnh/20031219/LLYLOGO )

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



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