RIDGEFIELD, Conn. and
INDIANAPOLIS, June 1, 2017 /PRNewswire/ -- Boehringer
Ingelheim and Eli Lilly and Company (NYSE: LLY) will present 33
abstracts highlighting the companies' wide range of diabetes
treatment options at the 77th American Diabetes
Association's (ADA) Scientific Sessions® in San Diego, June
9-13.
With compounds representing several of the largest diabetes
treatment classes, Boehringer Ingelheim and Lilly will feature
posters, abstracts and oral presentations for their range of
products, including Jardiance® (empagliflozin) tablets,
Tradjenta® (linagliptin) tablets and
Basaglar® (insulin glargine injection) 100 units/mL.
"Since diabetes requires a personalized treatment regimen best
suited to each individual, it is important that we understand how
different treatment options can help people with diabetes manage
their condition," said Thomas Seck, M.D., vice president, Clinical
Development and Medical Affairs, Primary Care, Boehringer Ingelheim
Pharmaceuticals, Inc. "With our broad portfolio of treatment
options, we, along with Lilly, are looking forward to showcasing
our research efforts and sharing new data at this year's ADA
Scientific Sessions."
Highlighted presentations and posters include the following:
JARDIANCE Data
JARDIANCE is approved by the U.S. Food
and Drug Administration to reduce the risk of cardiovascular death
in adults with type 2 diabetes and established cardiovascular
disease. JARDIANCE is also approved as an adjunct to diet and
exercise to improve glycemic control, or blood glucose levels, in
adults with type 2 diabetes.
A special session at ADA titled "What More Can We Learn from
EMPA-REG?" will review new analyses from the landmark EMPA-REG
OUTCOME® trial on Saturday, June
10 from 12:30-1:30 p.m.
PDT/3:30-4:30 p.m. EDT.
EMPA-REG OUTCOME was a long-term, multicenter, randomized,
double-blind, placebo-controlled trial which investigated the
effects of JARDIANCE compared with placebo when added to standard
of care type 2 diabetes and cardiovascular medicines in adults with
type 2 diabetes and established cardiovascular disease.
The session will include the following abstracts:
- Empagliflozin (EMPA) Reduces Heart Failure Irrespective of
Control of Blood Pressure (BP), Low Density Lipoprotein Cholesterol
(LDL-C), and HbA1c (Presenting author: Fitchett, D.) [1172-P]
- Empagliflozin reduces mortality in analyses adjusted for
control of blood pressure (BP), low density lipoprotein cholesterol
(LDL-C) and HbA1c over time (Presenting author: Zinman, B.)
[1173-P]
- Reduction in cardiovascular (CV) death with empagliflozin is
consistent across categories of baseline HbA1c and change in HbA1c:
results from EMPA-REG OUTCOME (Presenting author: Inzucchi, S.E.)
[1174-P]
- Empagliflozin and progression of kidney disease in patients at
high renal risk: slope analyses from EMPA-REG OUTCOME (Presenting
author: Wanner, C.) [1175-P]
- Empagliflozin and incidence of acute kidney injury: pooled
safety analysis in >12,000 individuals (Presenting author:
Wheeler, D.) [1176-P]
- Effect of the SGLT-2 inhibitor EMPA on vascular function and
central hemodynamics in patients with type 2 diabetes (Presenting
author: Schmieder, R.) [1177-P]
TRADJENTA Data
TRADJENTA is approved to lower
blood sugar in adults with type 2 diabetes along with diet and
exercise. A poster presentation will focus on the CARMELINA
(CArdiovascular Safety & Renal Microvascular outcomE study with
LINAgliptin) trial, which is investigating the impact of treatment
with TRADJENTA versus placebo on top of standard of care on
cardiovascular and renal outcomes.
Sunday, June 11,
12:00–1:00 p.m.
PDT/3:00–4:00 p.m.
EDT (general poster session)
- CARMELINA® Trial Baseline Characteristics: A
Cardiovascular and Renal Microvascular Outcome Trial with
Linagliptin in Patients with Type 2 Diabetes at High Vascular Risk
(Presenting author: Rosenstock, J.) [1284-P]
BASAGLAR Data
BASAGLAR is a long-acting insulin used
to control high blood sugar in adults and children with type 1
diabetes and adults with type 2 diabetes. BASAGLAR is not for
treating diabetic ketoacidosis. The following BASAGLAR data will be
included in a moderated poster discussion titled "Insulins with a
'Twist'" on Sunday, June 11 from
12:00-1:00 p.m. PDT/3:00-4:00 p.m. EDT.
Saturday, June 10, 11:30 a.m.–12:30 p.m. PDT/2:30–3:30 p.m. EDT (general poster session)
- Efficacy and Safety Between Insulin Glargine Products
(LY2963016 and Lantus®) in Patients with T2DM: the
ELEMENT 5 Study (Presenting author: Pollom, R.K.) [963-P]
A complete list of abstracts to be presented or published at the
77th ADA Scientific Sessions can be found here.
About the EMPA-REG OUTCOME Trial
(NCT01131676)
EMPA-REG OUTCOME was a long-term, multicenter,
randomized, double-blind, placebo-controlled trial of more than
7,000 patients, from 42 countries, with type 2 diabetes and
established cardiovascular disease.
The study assessed the effect of JARDIANCE (10 mg or 25 mg once
daily) added to standard of care compared with placebo added to
standard of care. Standard of care was comprised of
glucose-lowering agents and cardiovascular drugs (including for
blood pressure and cholesterol). The primary endpoint was defined
as time to first occurrence of cardiovascular death, non-fatal
heart attack or non-fatal stroke.
About Diabetes and Cardiovascular Disease
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 does not properly produce or use the hormone insulin.
Due to the complications associated with diabetes, such as high
blood sugar, high blood pressure and obesity, cardiovascular
disease is a major complication and the leading cause of death
associated with diabetes. People with diabetes are two to four
times more likely to develop cardiovascular disease than people
without diabetes. Approximately 50 percent of deaths in people with
type 2 diabetes worldwide and 68 percent of deaths in people with
type 2 diabetes in the U.S. are caused by cardiovascular disease.
In the U.S., health care costs for managing cardiovascular
conditions in patients with diabetes totaled more than $23 billion in 2012.
Having diabetes can shorten a person's lifespan by as much as
six years compared with someone without diabetes.* And having both
diabetes and a history of heart attack or stroke can shorten a
person's lifespan by as much as 12 years compared with someone
without these conditions.**
* Based on having a history of diabetes at age 60.
** Based on having a history of diabetes and heart attack or stroke
at age 60.
About Educational Initiatives
Given the critical
connection between diabetes and cardiovascular disease, Boehringer
Ingelheim and Eli Lilly and Company are committed to providing a
wide range of diabetes therapies along with programs and support to
raise awareness, understanding and action toward reducing the
impact of cardiovascular disease in people with type 2
diabetes.
What is JARDIANCE? (www.jardiance.com)
JARDIANCE is a prescription medicine used along with diet and
exercise to lower blood sugar in adults with type 2 diabetes.
JARDIANCE is also used to reduce the risk of cardiovascular
death in adults with type 2 diabetes who have known cardiovascular
disease.
JARDIANCE is not for people with type 1 diabetes or for people
with diabetic ketoacidosis (increased ketones in the blood or
urine).
IMPORTANT SAFETY INFORMATION
What is the most important information I should
know about JARDIANCE?
JARDIANCE can cause serious side effects, including:
- Dehydration. JARDIANCE can cause some people to have
dehydration (the loss of body water and salt). Dehydration may
cause you to feel dizzy, faint, light-headed, or weak, especially
when you stand up.
You may be at a higher risk of dehydration if you:
-
- have low blood pressure
- take medicines to lower your blood pressure including water
pills (diuretics)
- are on a low salt diet
- have kidney problems
- are 65 years of age or older.
- Ketoacidosis (increased ketones in your blood or urine).
Ketoacidosis is a serious condition and may need to be treated in
the hospital. Ketoacidosis may lead to death. Ketoacidosis occurs
in people with type 1 diabetes and can also occur in people with
type 2 diabetes taking JARDIANCE, even if blood sugar is less than
250 mg/dL. Stop taking JARDIANCE and call your doctor right away
if you get any of the following symptoms, and if possible,
check for ketones in your urine:
-
- nausea
- vomiting
- stomach-area (abdominal) pain
- tiredness
- trouble breathing
- Serious urinary tract infections. Serious urinary tract
infections can occur in people taking JARDIANCE and may lead to
hospitalization. Tell your doctor if you have symptoms of a urinary
tract infection such as a burning feeling when passing urine, a
need to urinate often or right away, pain in the lower part of your
stomach or pelvis, or blood in the urine. Sometimes people also may
have a fever, back pain, nausea or vomiting.
- Vaginal yeast infection. Women who take JARDIANCE may
get vaginal yeast infections. Talk to your doctor if you experience
vaginal odor, white or yellowish vaginal discharge (discharge may
be lumpy or look like cottage cheese), and/or vaginal itching.
- Yeast infection of the penis. Men who take JARDIANCE may
get a yeast infection of the skin around the penis, especially
uncircumcised males and those with chronic infections. Talk to your
doctor if you experience redness, itching or swelling of the penis,
rash of the penis, foul smelling discharge from the penis, and /or
pain in the skin around penis.
Who should not take JARDIANCE?
Do not take JARDIANCE if you are allergic to
empagliflozin or any of the ingredients in JARDIANCE. Symptoms of
serious allergic reactions to JARDIANCE may include:
- skin rash
- raised red patches on your skin (hives)
- swelling of the face, lips, tongue, and throat that may cause
difficulty breathing or swallowing.
If you have any of these symptoms, stop taking JARDIANCE and
contact your doctor or go to the nearest emergency room right
away.
Do not take JARDIANCE if you have severe kidney problems
or are on dialysis.
What should I tell my doctor before using
JARDIANCE?
Tell your doctor if you:
- have kidney problems. Your doctor may do blood tests to check
your kidneys before and during your treatment with JARDIANCE
- have liver problems
- have a history of urinary tract infections or problems with
urination
- are going to have surgery
- are eating less due to illness, surgery, or a change in your
diet
- have or have had problems with your pancreas, including
pancreatitis or surgery on your pancreas
- drink alcohol very often, or drink a lot of alcohol in the
short term ("binge" drinking)
- have any other medical conditions
- are pregnant or planning to become pregnant. It is unknown if
JARDIANCE will harm your unborn baby
- are breastfeeding, or plan to breastfeed. It is unknown if
JARDIANCE passes into your breast milk.
Tell your doctor about all the medicines you take
including prescription and over-the-counter medicines, vitamins,
and herbal supplements. Especially tell your doctor if you take
water pills (diuretics) or medicines that can lower your blood
sugar such as insulin.
What are other possible side effects of
JARDIANCE?
- Low blood sugar (hypoglycemia): if you take
JARDIANCE with another medicine that can cause low blood sugar,
such as sulfonylurea or insulin, your risk of low blood sugar is
higher. The dose of your sulfonylurea or insulin may need to be
lowered. Symptoms of low blood sugar may include:
-
- Headache
- Drowsiness
- Weakness
- Dizziness
- Confusion
- Irritability
- Hunger
- Fast heartbeat
- Sweating
- Shaking or feeling jittery
- Kidney Problems. Sudden kidney injury has happened in
people taking JARDIANCE. Talk to your doctor right away if you
reduce the amount you eat or drink, or if you lose liquids; for
example, from vomiting, diarrhea, or being in the sun too long.
- Increased fats in your blood (cholesterol).
The most common side effects of JARDIANCE
include urinary tract infections, and yeast infections in
females.
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 information, please see full Prescribing Information
and Patient Information.
JAR CONS ISI 1.11.17
What is TRADJENTA? (www.tradjenta.com)
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 of these
symptoms, 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.
*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.
- Skin Reaction. Some people who take medicines called DPP-4
inhibitors like TRADJENTA, may develop a skin reaction called
bullous pemphigoid which can be serious and may need to be treated
in a hospital. Tell your doctor right away if you develop
blisters.
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 9JAN2017
For more safety information, please see Prescribing Information
and Medication Guide.
About BASAGLAR (www.basaglar.com)
In December 2015, BASAGLAR was the first insulin product
approved through an abbreviated approval pathway under the Federal
Food, Drug, and Cosmetic Act. The extensive clinical development
program for BASAGLAR included pharmacokinetic and pharmacodynamic
studies, as well as Phase III studies in people with type 1 and
type 2 diabetes comparing the safety and efficacy of BASAGLAR
to U.S.-and non-U.S.-approved Lantus®.
BASAGLAR Indication
BASAGLAR is a long-acting insulin
used to control high blood sugar in adults and children with type 1
diabetes and adults with type 2 diabetes.
BASAGLAR is not for treating diabetic ketoacidosis.
Important Safety Information
Do not take
BASAGLAR® (insulin glargine injection) during
episodes of low blood sugar or if you are allergic to insulin
glargine or any of the ingredients in BASAGLAR.
Do NOT reuse needles or share insulin pens, even if the
needle has been changed.
Before starting BASAGLAR, tell your doctor about all your
medical conditions, including if you have liver or kidney problems,
if you are pregnant or planning to become pregnant, or if you are
breastfeeding or planning to breastfeed.
BASAGLAR should be taken once a day at the same time every
day. Test your blood sugar levels while using insulin. Do not make
any changes to your dose or type of insulin without talking to your
healthcare provider. Any change of insulin should be made
cautiously and only under medical supervision.
The most common side effect of insulin, including BASAGLAR,
is low blood sugar (hypoglycemia), which may be serious and life
threatening. Signs and symptoms may include dizziness or
light-headedness, sweating, confusion, headache, blurred vision,
slurred speech, shakiness, fast heartbeat, anxiety, irritability,
mood change, or hunger.
Do NOT dilute or mix BASAGLAR with any other insulin or
solution. It will not work as intended and you may lose
blood sugar control, which could be serious. BASAGLAR must
only be used if the solution is clear and colorless with no
particles visible. Always make sure you have the correct insulin
before each injection.
BASAGLAR may cause serious side effects that can lead to
death, such as severe allergic reactions. Get emergency
help if you have:
- A rash over your whole body
- Trouble breathing
- A fast heartbeat
- Sweating
- Swelling of your face, tongue, or throat
- Shortness of breath
- Extreme drowsiness, dizziness, or confusion
Heart failure can occur if you are taking insulin together with
medicines called TZDs (thiazolidinediones), even if you have never
had heart failure or other heart problems. If you already have
heart failure, it may get worse while you take TZDs with BASAGLAR.
Your treatment with TZDs and BASAGLAR may need to be changed
or stopped by your doctor if you have new or worsening heart
failure. Tell your doctor if you have any new or worsening symptoms
of heart failure, including:
- Shortness of breath
- Swelling of your ankles or feet
- Sudden weight gain
Tell your doctor about all the medications you take, including
over-the-counter medicines, vitamins, and herbal supplements.
While using BASAGLAR, do not drive or operate heavy machinery
until you know how BASAGLAR affects you. Do not drink alcohol
or use other medicines that contain alcohol.
Other possible side effects may include swelling, weight gain,
low potassium, injection site reactions, including changes in fat
tissue at the injection site, and allergic reactions. These
are not all the possible side effects. Call your doctor
for medical advice about side effects.
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.
The BASAGLAR KwikPen is a disposable, prefilled
insulin pen. Please talk to your healthcare provider about proper
injection technique and follow instructions in the Instructions for
Use that accompanies the pen. BASAGLAR is available by prescription
only.
BV DTC ISI 24JUN2016
Please see Prescribing
Information and Patient
Information provided.
Please see Instructions for Use that come with the
pen.
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.
Boehringer Ingelheim
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 top 20 pharmaceutical
companies. Headquartered in Ingelheim, Germany, the company operates globally with
approximately 50,000 employees. Since its founding in 1885, the
company has remained family-owned and today creates value through
innovation for three business areas including human
pharmaceuticals, animal health and biopharmaceutical contract
manufacturing.
Boehringer Ingelheim is committed to improving lives and
providing valuable services and support to patients and their
families. Our employees create and engage in programs that
strengthen our communities. Please visit our website to learn more
about how we make more health for more people through our Corporate
Social Responsibility initiatives.
In 2016, Boehringer Ingelheim achieved net sales of about
$17.6 billion
(15.9 billion euros). R&D expenditure corresponds to
19.6 percent of its net sales.
For more information please visit www.boehringer-ingelheim.us,
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 (as
that term is defined in the Private Securities Litigation Reform
Act of 1995) about JARDIANCE, TRADJENTA and BASAGLAR,
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
JARDIANCE, TRADJENTA and BASAGLAR 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.
Jardiance®, EMPA-REG OUTCOME® and
Tradjenta® are registered trademarks of Boehringer
Ingelheim.
BASAGLAR® is a registered trademark of Eli Lilly
and Company.
The other trademarks referenced above are owned by third parties
not affiliated with Boehringer Ingelheim Pharmaceuticals,
Inc./Lilly USA, LLC.
P-LLY
PC-03957
CONTACT:
Jen Forsyth
Director,
Public Relations
Boehringer Ingelheim Pharmaceuticals, Inc.
Email: jennifer.forsyth@boehringer-ingelheim.com
Phone: (203) 791-5889
Dani
Barnhizer
Communications Manager
Lilly Diabetes
Email: dbarnhizer@lilly.com
Phone: (317) 607-6119
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/boehringer-ingelheim-and-lilly-diabetes-alliance-to-present-33-abstracts-at-the-american-diabetes-associations-77th-scientific-sessions-300466806.html
SOURCE Eli Lilly and Company