RIDGEFIELD, Conn. and
INDIANAPOLIS, June 11, 2016 /PRNewswire/ -- Results from
the MARLINA-T2D™ trial demonstrated that Tradjenta®
(linagliptin), which is marketed by Boehringer Ingelheim and Eli
Lilly and Company (NYSE: LLY), reduced blood sugar in adults with
type 2 diabetes (T2D) who are at risk for kidney impairment, with a
renal safety profile similar to that seen in other trials. The
findings will be presented tomorrow at the American Diabetes
Association 76th Scientific Sessions® in New Orleans.
"Up to half of people with type 2 diabetes experience long-term
problems with kidney function," 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-T2D trial. "Diabetes treatment options are generally
limited for this group. These results support the use of TRADJENTA,
with just one dose for all patients, including those with type 2
diabetes who have early signs of kidney disease."
In people who have diabetes, high levels of blood glucose can
damage the kidneys' filters. Over time, the damage can increase
risk for developing kidney impairment. One of the first signs of
damaged kidneys and early stage kidney disease is leakage of the
protein albumin out of the kidneys into the urine — a condition
known as albuminuria that indicates risk for further worsening of
kidney function.
MARLINA-T2D examined the safety and efficacy of TRADJENTA versus
placebo in 360 patients with T2D and albuminuria (defined as
urinary albumin-to-creatinine ratio (UACR) 30-3000 mg/g
creatinine). At 24 weeks, TRADJENTA was associated with a
significant 0.6 percent reduction in A1C (a measure of average
blood glucose over the past two to three months) versus placebo.
Change in albuminuria, as measured by UACR,
was non-significant with TRADJENTA versus
placebo. TRADJENTA was well tolerated in the trial, with a
renal safety profile consistent with that of previous clinical
trials.
"The treatment of type 2 diabetes is rarely a simple
matter—people with this condition are often dealing with a
multitude of complications, including problems with their kidneys,"
said Professor Hans-Juergen Woerle,
global vice president medicine, Boehringer Ingelheim. "The
MARLINA-T2D trial results further support the use of TRADJENTA as a
once-daily therapy that does not require dose adjustment regardless
of renal function."
About Diabetes
Approximately 29 million
Americans and an estimated 415 million people worldwide have
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. Type 2 diabetes
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
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 over-the-counter 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.
*These trademarks are owned by
third parties not affiliated with TRADJENTA.
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.
- Joint pain. Some people who take medicines called DPP-4
inhibitors like TRADJENTA, may develop joint pain that can be
severe. Call your doctor if you have severe joint pain.
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/medwatch or call
1-800-FDA-1088.
TJ CONS lSI 31AUG2015
For more safety information, please see Medication Guide and
full Prescribing Information.
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 Pharmaceuticals,
Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in
Ridgefield, CT, is the largest
U.S. subsidiary of Boehringer Ingelheim Corporation.
Boehringer Ingelheim is one of the world's 20 leading
pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with
145 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 2015, Boehringer Ingelheim achieved net sales of about
$15.8 billion dollars (14.8 billion euros). R&D expenditure
corresponds to 20.3 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
or follow @LillyDiabetes.
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 (as
that term is defined in the Private Securities Litigation Reform
Act of 1995) about TRADJENTA and reflects Lilly's current belief.
However, as with any pharmaceutical product, there are substantial
risks and uncertainties in the process of development and
commercialization. Among other things, there can be no guarantee
that future study results will be consistent with the results to
date or that TRADJENTA will receive additional regulatory
approvals. For further discussion of these and other risks and
uncertainties, see Lilly's most recent Form 10-K and Form 10-Q
filings with the United States Securities and Exchange Commission.
Except as required by law, Lilly undertakes no duty to update
forward-looking statements to reflect events after the date of this
release.
Tradjenta® is a registered trademark of Boehringer Ingelheim
P-LLY
PC-TJ-0098-PR
CONTACT:
Lauren
Murphy, MBA
Associate Director, Public Relations
Boehringer Ingelheim Pharmaceuticals, Inc.
Email: lauren.murphy@boehringer-ingelheim.com
Phone: (203) 448-1982
Molly
McCully
Communications Manager
Lilly Diabetes
Email: mccully_molly@lilly.com
Phone: (317) 478-5423
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SOURCE Eli Lilly and Company; Boehringer Ingelheim