Retrospective analysis of linagliptin data in sub-populations with type 2 diabetes presented at AACE 22nd Annual Scientific &

  Retrospective analysis of linagliptin data in sub-populations with type 2
    diabetes presented at AACE 22nd Annual Scientific & Clinical Congress

Retrospective pooled analyses evaluated linagliptin treatment in American
Hispanic/Latino people with type 2 diabetes, as well as in people living with
type 2 diabetes for at least 10 years

PR Newswire

RIDGEFIELD, Conn. and INDIANAPOLIS, May 6, 2013

RIDGEFIELD, Conn. and INDIANAPOLIS, May 6, 2013 /PRNewswire/ --Boehringer
Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company (NYSE: LLY) today
announced results from two new pooled analyses of phase III data with the
dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin, presented at the
American Association of Clinical Endocrinologists (AACE) 22^nd Annual
Scientific & Clinical Congress.

In one retrospective pooled analysis, data were included from Hispanic/Latino
adults with type 2 diabetes (T2D), a population that is disproportionately
affected by T2D.^1 Data pooled from six phase III studies showed that
treatment with linagliptin reduced glucose levels (HbA[1c]) versus placebo in
this patient population.

In a second retrospective analysis, data were pooled from two phase III
studies that included people with long-standing T2D (>/=10 years). The
analysis showed reductions in HbA[1c] from baseline with linagliptin versus
placebo.

"Response to treatment can vary between sub-populations of adults with type 2
diabetes," said Christophe Arbet-Engels, MD, PhD, vice president, clinical
development and medical affairs metabolic, Boehringer Ingelheim
Pharmaceuticals, Inc. "Those with long-standing type 2 diabetes or of
Hispanic/Latino origin are often difficult to treat or under-treated."

About Poster No. 1118 - Sub-population of Hispanic/Latino Adults with T2D
The findings from the first presentation were derived from six randomized,
double-blind, placebo-controlled phase III studies of linagliptin 5 mg/d given
as monotherapy or in addition to common glucose-lowering therapies.^1 Of the
six studies included in the analysis, two were 18 weeks in duration and four
were 24 weeks in duration.^1 A total of 731 American Hispanic/Latino patients
(467 who received linagliptin and 264 who received placebo) were included in
the full analysis set (FAS), which was comprised of all randomized patients
treated with at least one dose of the study drug, and who had their HbA[1c]
measured at baseline and at least once during the treatment period.^1 The
primary efficacy endpoint was change in HbA[1c] from baseline to 18 or 24
weeks.^1 Baseline HbA[1c] levels were 8.25% in the linagliptin group and
8.23% in the placebo group.^1

Key findings of the retrospective analysis for the linagliptin treatment group
included^1:

  o0.58% reduction in HbA[1c] compared to placebo after 24 weeks of treatment
    (95% confidence interval [CI]-0.74, -0.42; p<0.0001)
  o14.6% reported drug-related AEs vs. 18.4% for placebo

About Poster No. 1119 - Sub-population of Adults with Long-standing T2D
For the second retrospective analysis, researchers pooled data from two phase
III studies of 202 patients with a reported T2D duration of ≥10 years, who
received either linagliptin 5 mg/d (n=122) or placebo (n=80).^2 The average
exposure to both treatments was 169 days.^2 A total of 192 patients (117
linagliptin and 75 placebo) were included in the FAS.^2 The primary endpoint
was change in HbA[1c] from baseline to 24 weeks.^2 Baseline HbA[1c] levels
were 8.07% in the linagliptin group and 8.45% in the placebo group.^2

Key findings of the retrospective analysis for the linagliptin treatment group
included^2:

  o0.66% reduction in HbA[1c] compared to placebo after 24 weeks of treatment
    (CI: -0.95, -0.38; p<0.0001)
  o21.3% reported treatment-related AEs vs. 16.3% in the placebo arm

Linagliptin, which is marketed as Tradjenta® (linagliptin) tablets in the
U.S., is a once-daily 5mg 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). Linagliptin is a
DPP-4 inhibitor that does not require dose adjustments, regardless of
declining renal function or hepatic impairment.

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 away.

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 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 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.

About Diabetes
Approximately 25.8 million Americans^3 and an estimated 371 million people
worldwide^4 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.^3
Diabetes is a chronic condition that occurs when the body either does not
properly produce, or use, the hormone insulin.^5

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
www.lilly.com.

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.

As a central element of its culture, Boehringer Ingelheim has a demonstrated
commitment to corporate social responsibility.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 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
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

TJ562305PR

This press release contains forward-looking statements about linagliptin
tablets for the treatment of type 2 diabetes. 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. 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.

CONTACT:

Catherine London
Associate Director, Public Relations
Boehringer Ingelheim Pharmaceuticals, Inc.
Email: usnews@boehringer-ingelheim.com
Phone: (203) 798-4638

Tammy Hull
Communications Manager
Lilly Diabetes
Email: hullta@lilly.com
Phone: (317) 651-9116

References

1.Davidson J, et al. Efficacy and safety of linagliptin in Hispanic/ Latino
    patients with type 2 diabetes: pooled analysis from six randomized
    placebo-controlled phase 3 trials. Poster No: 1118. Presented at the
    American Association of Clinical Endocrinologists (AACE) 22nd Annual
    Scientific & Clinical Congress. May 1-5, Phoenix, AZ.
2.Lajara R, et al. Efficacy and safety of linagliptin in individuals with
    long-standing type 2 diabetes (>/= 10 years). Poster No: 1119. Presented
    at the American Association of Clinical Endocrinologists (AACE) 22nd
    Annual Scientific & Clinical Congress. May 1-5, Phoenix, AZ.
3.Centers for Disease Control and Prevention. National diabetes fact sheet:
    national estimates and general information on diabetes and pre-diabetes in
    the United States, 2011. Atlanta, GA: U.S. Department of Health and Human
    Services, Center for Disease Control and Prevention, 2011.
4.International Diabetes Federation. Diabetes Atlas, 5th Edition: Fact
    Sheet. 2012.
5.International Diabetes Federation. IDF Diabetes Atlas, 5th Edition: What
    is Diabetes? http://www.idf.org/diabetesatlas/5e/what-is-diabetes.
    Accessed on: April 10, 2013.

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

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SOURCE Eli Lilly and Company; Boehringer Ingelheim
 
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