Boehringer Ingelheim and Lilly initiate MARLINA clinical trial to evaluate use of Tradjenta® (linagliptin) tablets in patients

Boehringer Ingelheim and Lilly initiate MARLINA clinical trial to evaluate use
   of Tradjenta® (linagliptin) tablets in patients with type 2 diabetes and

PR Newswire

RIDGEFIELD, Conn. and INDIANAPOLIS, March 19, 2013

RIDGEFIELD, Conn. and INDIANAPOLIS, March 19, 2013 /PRNewswire/ --Boehringer
Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company (NYSE: LLY) today
announced the initiation of a Phase IIIb trial to evaluate the glycemic
efficacy and safety of linagliptin in patients with type 2 diabetes with
prevalent albuminuria (defined as urinary albumin-to-creatinine ratio (UACR)
30-3000 mg/g creatinine), while remaining on current standard therapy for
diabetic nephropathy. The name of the clinical trial is MARLINA (efficacy,
safety & Modification of Albuminuria in type 2 diabetes subjects with Renal
disease with LINAgliptin), and it can be found on under
identifier number, NCT01792518.

In diabetes, high levels of blood glucose can damage the kidneys' filters.
Over time, damage to the kidneys' filters can leave people with type 2
diabetes at risk for developing renal impairment. One of the first signs of
damaged kidneys and early-stage renal disease is having the protein albumin
leak out of the kidneys into the urine.^1

"What is of particular interest is that this study will evaluate the glycemic
efficacy and safety of linagliptin therapy in patients with type 2 diabetes
whose kidneys are excreting significant amounts of albumin, a marker of both
kidney damage as well as an overall increased cardiovascular risk," said
Professor Per-Henrik Groop, Professor of Nephrology, and Chief Physician at
the Division of Nephrology, Helsinki University Central Hospital, Helsinki,
Finland and Principal Investigator of the MARLINA trial.

The primary endpoint of MARLINA is the change from baseline in HbA1c after 24
weeks of treatment. The study is expected to be completed in 2014.

"The initiation of this new trial marks an important study as it may provide
us with further insight into treating patients with type 2 diabetes who also
have renal disease," said Christophe Arbet-Engels, MD, PhD, MBA, vice
president, metabolic-clinical development and medical affairs, Boehringer
Ingelheim. "MARLINA demonstrates our ongoing commitment to diabetes research
and the development of products aimed at meeting the specific needs of the
diabetes community."

Linagliptin, marketed in the U.S. as TRADJENTA^®, is a once-daily tablet used
along with diet and exercise to improve glycemic control 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). With linagliptin, no dose adjustment is required regardless of
declining renal function.

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

About MARLINA Study Design
MARLINA is a 24-week, Phase IIIb, multicenter, multinational, randomized,
double-blind, placebo-controlled, parallel-group study to evaluate the
glycemic efficacy of once-daily administration of linagliptin 5 mg in patients
with type 2 diabetes with micro- or macroalbuminuria (30-3000mg/g creatinine)
in addition to current standard treatment for diabetic nephropathy
angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker.

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

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 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: For full prescribing
information visit:
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.

About Diabetes
Approximately 25.8 million Americans^2 and an estimated 371 million people
worldwide^3 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.^2
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 three 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 or

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 and
follow us on Twitter at

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

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

This press release contains forward-looking statements about TRADJENTA
tablets. 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.


Catherine London
Associate Director, Communications and Public Relations
Boehringer Ingelheim Pharmaceuticals, Inc.
Phone: (203) 798-4638

Tammy Hull
Communications Manager
Lilly Diabetes
Phone: (317) 651-9116

^1 IDF. ISN: Diabetes and kidney disease. Time to act. Brussels, 2003.

^2 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.

^3 International Diabetes Federation. Diabetes Atlas, 5th Edition: Fact
Sheet. 2012.

^4 International Diabetes Federation. IDF Diabetes Atlas, 5th Edition: What is
Diabetes? Accessed on:
July 27, 2012.

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

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