Diabetes Alliance to Feature 17 Presentations for Linagliptin and
Investigational Compound Empagliflozin^ During the 49th Annual Meeting of the
European Association for the Study of Diabetes (EASD)
Presentations at EASD to include safety and efficacy data for the Diabetes
RIDGEFIELD, Conn. and INDIANAPOLIS, Sept. 17, 2013
RIDGEFIELD, Conn. and INDIANAPOLIS, Sept. 17, 2013 /PRNewswire/ -- Boehringer
Ingelheim and Eli Lilly and Company (Lilly; NYSE: LLY) today announced they
will feature five oral and 12 poster presentations for linagliptin and the
investigational compound empagliflozin^^ at the 49^th Annual Meeting of the
European Association for the Study of Diabetes (EASD), which will take place
in Barcelona from September 23 – 27.
A total of eight clinical abstracts for the investigational agent
empagliflozin will be presented. Empagliflozin is a sodium glucose
co-transporter 2 (SGLT2) inhibitor being investigated for the reduction of
blood glucose levels in adults with type 2 diabetes (T2D). The emerging SGLT2
inhibitor class removes excess glucose through the urine by blocking glucose
re-absorption by the kidney.
^^Empagliflozin is an investigational compound. Its safety and efficacy have
not been established.
Details of clinical presentations for empagliflozin are as follows:^1
Tuesday, September 24, 12:30–1:30 CET, General Poster Session
oEmpagliflozin as Add-on to Basal Insulin for 78 Weeks Improves Glycemic
Control and Weight Loss in Insulin-Treated Type 2 Diabetes (T2DM)
(Presenting Author: J. Rosenstock) [Poster No. 931]
oSafety and Efficacy of Empagliflozin Monotherapy in a 52-Week Study in
Japanese Patients with Type 2 Diabetes Mellitus (Presenting Author: H. J.
Woerle) [Poster No. 930]
oMetabolic Response to Sodium Glucose Transporter 2 (SGLT2) Inhibition with
Empagliflozin in Patients with Type 2 Diabetes (T2D) (Presenting Author:
E. Ferrannini) [Poster No. 932]
Tuesday, September 24, 1:45–2:45 CET, General Poster Session
oEmpagliflozin Improves Blood Pressure in Patients with Type 2 Diabetes
(T2DM) and Hypertension (Presenting Author: I. Tikkanen) [Poster No. 942]
oEmpagliflozin Improved Glycemic Parameters and Cardiovascular Risk Factors
in Patients with Type 2 Diabetes (T2DM): Pooled Data from Four Pivotal
Phase III Trials (Presenting Author: T. Hach) [Poster No. 943]
oDesign of the Empagliflozin Cardiovascular Outcome Event Trial in Type 2
Diabetes Mellitus (Presenting Author: S. E. Inzucchi) [Poster No. 944]
Wednesday, September 25, 12:30–1:30 CET, General Poster Session
oEmpagliflozin in Patients with Type 2 Diabetes Mellitus (T2DM) and Stage
3A, 3B and 4 Chronic Kidney Disease (CKD) (Presenting Author: A. Mithal)
[Poster No. 952]
Thursday, September 26, 3:00 – 4:30 CET, Oral Presentation
oThe Sodium Glucose Co-Transporter-2 (SGLT2) Inhibitor Empagliflozin
Improves Glycemic Control in Patients with Type 1 Diabetes: A Single-Arm
Clinical Trial (Presenting Author: B. A. Perkins) [Oral Presentation No.
A total of nine clinical and pre-clinical abstracts for linagliptin will also
be presented. Linagliptin is an inhibitor of the enzyme, dipeptidyl
peptidase-4 (DPP-4), which breaks down the incretin hormones glucagon-like
peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) that
are involved with regulating blood sugar.^2
Details of all presentations for linagliptin are as follows:^1
Wednesday, September 25, 10:45 – 12:15 CET, Oral Presentation
oBaseline Characteristics of Participants Enrolled in the Cardiovascular
Outcome Study of Linagliptin Versus Glimepiride in Early Type 2 Diabetes
(CAROLINA) (Presenting Author: J. Rosenstock) [Oral Presentation No. 73] ^
Wednesday, September 25, 12:30 – 1:30 CET, General Poster Sessions
oEfficacy and Safety of Linagliptin as Add-On Therapy to Basal Insulin and
Metformin in Patients with Type 2 Diabetes (Presenting Author: S.
Duran-Garcia) [Poster No. 892]
Wednesday, September 25, 3:00 – 4:30 CET, Oral Presentation
oCardiovascular (CV) Safety of Linagliptin in Patients with Type 2 Diabetes
(T2D): A Pooled Comprehensive Analysis of Prospectively Adjudicated CV
Events in Phase 3 Studies (Presenting Author: O. E. Johansen) [Oral
Presentation No. 112] ^
oLinagliptin and The Angiotensin II Receptor Blocker Telmisartan Show
Comparable Efficacy but Different Renoprotective Pathways in Rats with 5/6
Nephrectomy (Presenting Author: B. Hocher) [Oral Presentation No. 143]
Thursday, September 26, 10:45 – 12:15 CET, Oral Presentation
oInsights into the Mechanism of Action of Linagliptin in Reducing Ischaemic
Brain Damage Following Stroke in Diabetic and Non-Diabetic Mice
(Presenting Author: V. Darsalia) [Oral Presentation No. 152]
Thursday, September 26, 12:30 – 1:30 CET, General Poster Session
oRenal Safety and Outcomes with Linagliptin: Meta-Analysis of Individual
Data for 5466 Patients with Type 2 Diabetes (Presenting Author: M. von
Eynatten) [Poster No. 913]
oLinagliptin Versus Placebo Followed by Glimepiride in Type 2 Diabetes
Patients with Moderate to Severe Renal Impairment (Presenting Author: P-H.
Groop) [Poster No. 914]
Thursday, September 26, 1:45 – 2:45 CET, General Poster Session
oSafety and Tolerability of Linagliptin in 7400 Patients with Type 2
Diabetes: A Pooled Comprehensive Analysis of Prospective Safety Reporting
in Placebo-Controlled Studies (Presenting Author: M. Lehrke) [Poster No.
oRenal Safety of Linagliptin in Elderly Patients with Type 2 Diabetes:
Analysis of Pooled Patient Data From 7 Phase 3 Clinical Trials (Presenting
Author: A. H. Barnett) [Poster No. 926]
Linagliptin, which is marketed as TRADJENTA^® (linagliptin) tablets in the
U.S., is a once-daily 5-mg tablet 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). TRADJENTA has not been
studied in patients with a history of pancreatitis, and it is unknown whether
patients with a history of pancreatitis are at an increased risk for the
development of pancreatitis while using TRADJENTA.
What are TRADJENTA 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).
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
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
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 right away.
What should I tell my doctor before using TRADJENTA?
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
Especially tell your doctor if you take
oOther medicines that can lower your blood sugar, such as a sulfonylurea or
oTRADJENTA 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.
oSigns and symptoms of low blood sugar may include headache,
drowsiness, weakness, dizziness, confusion, irritability, hunger,
fast heartbeat, sweating, or feeling jittery.
orifampin (Rifadin®, Rimactane®, Rifater®, Rifamate®)*, an antibiotic that
is used to treat tuberculosis.
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?
The most common side effects of TRADJENTA include stuffy or runny nose, sore
throat, cough and diarrhea.
You are encouraged to report negative side effects of prescription drugs to
the U.S. FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
For more safety information, please see Medication Guide and full Prescribing
TJ CONS ISI 19JUNE2013
*The brands listed are trademarks of their respective owners and are not
trademarks of Boehringer Ingelheim Pharmaceuticals, Inc. The makers of these
brands are not affiliated with and do not endorse Boehringer Ingelheim
Pharmaceuticals, Inc., or its products.
To learn more about TRADJENTA visit: www.TRADJENTA.com. For full Prescribing
Information and Medication Guide 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.
Approximately 25.8 million Americans^6 and an estimated 371 million people
worldwide have type 1 or type 2 diabetes.^3 Type 2 diabetes is the most common
type, accounting for an estimated 90 to 95 percent of all diabetes cases.^4
Diabetes is a chronic condition that occurs when the body either does not
properly produce, or use, the hormone insulin.^5 Diabetes was estimated to
cost the U.S. $245 billion in 2012^7.
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 compounds representing
several of the largest diabetes 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
About Boehringer Ingelheim
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the
largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT)
and a member of the Boehringer Ingelheim group of companies.
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical
companies. Headquartered in Ingelheim, Germany, it operates globally with 140
affiliates and more than 46,000 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.
Social responsibility is a central element of Boehringer Ingelheim's culture.
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
In 2012, Boehringer Ingelheim achieved net sales of about $19.1 billion (14.7
billion euro). R&D expenditure in the business area Prescription Medicines
corresponds to 22.5% of its net sales.
For more information please visit www.us.boehringer-ingelheim.com.
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 www.lillydiabetes.com.
This press release contains forward looking statements about empagliflozin, an
investigational compound being studied for the treatment of type 2 diabetes,
and linagliptin, a DPP-4 inhibitor approved for the treatment of type 2
diabetes along with diet and exercise. 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 linagliptin will be
commercially successful, or that empagliflozin will receive regulatory
approvals or prove to be commercially successful or that empagliflozin will
receive regulatory approvals or prove to 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.
Associate Director, Public Relations
Boehringer Ingelheim Pharmaceuticals, Inc.
Phone: (203) 798-4638
Phone: (317) 651-9116
1. EASD 2013 online program, Accessed:
2. TRADJENTA® (linagliptin) tablets. Highlights of Prescribing Information.
3. International Diabetes Federation. IDF Diabetes Atlas, 5th Edition: The
Global Burden (2012 Update - 5th Edition).
4. World Health Organization. Fact Sheet No. 312 What is Diabetes? 2009
[cited January 2013]; Available from:
5. International Diabetes Federation. What is Diabetes? IDF Diabetes Atlas.
2011; (5th Edition)
6. American Diabetes Association. Economic costs of diabetes in the U.S. in
2012. Diabetes Care. 2013;36(4):1033-1046.
7. 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.
(Logo: http://photos.prnewswire.com/prnh/20110825/DE57898LOGO )
SOURCE Eli Lilly and Company; Boehringer Ingelheim
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