TIDMLEL
Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company present
new linagliptin data at American Diabetes Association's 72nd Scientific
Sessions®
Two phase 3 studies and a post-hoc analysis provide additional data evaluating
efficacy and safety of linagliptin
Ridgefield, CT and Indianapolis, IN, June 9, 2012 - Boehringer Ingelheim
Pharmaceuticals, Inc. and Eli Lilly and Company (NYSE: LLY) presented results
from two randomized phase 3 clinical trials and a post-hoc analysis for
linagliptin at the American Diabetes Association's (ADA's) 72nd Scientific
Sessions®. The new studies provide additional data evaluating the efficacy and
safety of linagliptin (alone or in combination with other diabetes therapies)
in adults with type 2 diabetes.,,3 Linagliptin, marketed in the U.S. as
Tradjenta®, is a once-daily tablet that is used along with diet and exercise to
improve glycemic control in adults with type 2 diabetes.4
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).
TRADJENTA has not been studied in combination with insulin.
"Patients with type 2 diabetes often need more than one therapy to improve
their glycemic control," said Dr. Lance A. Sloan, MD, FACE, President and Chief
Medical Officer, Texas Institute for Kidney and Endocrine Disorders. "These new
studies provide additional data further evaluating the efficacy and safety of
linagliptin, alone or in combination, in adults with type 2 diabetes who have
experienced insufficient glycemic control on other treatments."
Interim results of the first phase 3 study presented here (abstract #999-P)
showed that adding linagliptin to a background of basal insulin - alone or in
combination with metformin and/or pioglitazone - demonstrated a
placebo-adjusted reduction in hemoglobin A1c (HbA1c or A1C) of 0.65 percent
from a baseline A1C of 8.3 percent1 at 24 weeks versus adding placebo to these
background therapies in adult patients with type 2 diabetes. A1C is measured in
people with diabetes to provide an index of blood glucose control for the
previous two to three months.
In a second phase 3 study (abstract #1017-P), linagliptin showed a 0.64 percent
placebo-adjusted reduction in A1C (p<0.0001) at 24 weeks from baseline (A1C =
7.8 percent) in elderly patients (mean age 74.9 years) insufficiently
controlled despite previous treatment with metformin and/or sulfonylurea and/or
insulin therapy. Hypoglycemia occured in 24.1 percent of patients on
linagliptin versus 16.5 percent of patients on placebo.2
The third abstract was a post-hoc analysis (abstract #1044-P) in which patients
with uncontrolled A1C on a background of metformin were randomized to add-on
linagliptin or glimepiride. The endpoint of the 104-week exploratory analysis
was to assess the proportions achieving a glycemic target A1C <7 percent
without weight gain (defined as <1 kg increase in body weight vs baseline) and
without hypoglycemia. After 104 weeks of treatment, both linagliptin and
glimepiride reduced mean A1C levels by 0.6 percent from baseline (baseline: 7.2
percent linagliptin, 7.3 percent glimepiride) and 76 percent of patients in
both groups achieved target A1C <7 percent. Analyses were based on a per
protocol population on treatment after 104 weeks without the use of rescue
medication. Fewer patients taking linagliptin versus glimepiride experienced
hypoglycemia (very low blood sugar levels) and weight gain during the trial
period (6 percent versus 42 percent and 22 percent versus 55 percent,
respectively).3 A significantly higher proportion in the linagliptin group than
the glimepiride group achieved the composite endpoint (54 percent versus 23
percent, respectively).
Abstract 999-P Study Design and Safety
This 52-week, multicenter, randomized, placebo-controlled phase 3 study
evaluated the efficacy and safety of linagliptin as an add-on therapy to basal
insulin alone, or in combination with metformin and/or pioglitazone in adult
patients with type 2 diabetes. The study included 1,261 patients who had
inadequate glycemic control with a stable dose of basal insulin with or without
metformin and/or pioglitazone (i.e., insulin glargine, insulin detemir or NPH
insulin).1 Patients were randomized to receive either 5 mg of linagliptin or
placebo once daily. The primary efficacy endpoint was the mean change in A1C
from baseline to week 24, during which time the basal insulin and metformin and
/or pioglitazone dose remained stable.1
The overall frequency of adverse events (linagliptin, 71.8 percent versus
placebo, 72.5 percent) and hypoglycemia (linagliptin, 25.7 percent versus
placebo, 27.3 percent) were similar in both groups.1 In addition, body weight
did not significantly change from baseline (-0.17 kg +0.11 versus +0.13 kg +
0.12; p=0.07) in the linagliptin and placebo groups, respectively.1
Abstract 1017-P Study Design and Safety
This randomized, placebo-controlled, double-blind phase 3 study evaluated the
efficacy and safety of linagliptin 5 mg daily in 241 elderly patients (74.9
years +4.3 years) with type 2 diabetes, who had insufficient glycemic control
despite treatment with metformin, sulfonylurea and/or insulin therapy. Patients
were randomized to receive either 5 mg of linagliptin once daily, or placebo as
an add-on to stable background therapy over 24 weeks.2 Patients were taking
either metformin (84.9 percent), sulfonylurea (57.6 percent) or insulin therapy
(21.0 percent). Baseline A1C was 7.8 percent and 7.7 percent in the linagliptin
and placebo groups, respectively.2 Drug-related adverse events were experienced
by 21.0 percent and 13.9 percent of linagliptin and placebo patients,
respectively. Hypoglycemia occurred in 24.1 percent and 16.5 percent,
respectively (p=0.1625).2
Abstract 1044-P Study Design and Safety
An exploratory analysis of a 104-week study assessed the proportions of adult
patients with type 2 diabetes treated with linagliptin versus glimepiride both
on a background of metformin who achieved a glycemic target of A1C <7 percent
without weight gain (defined as <1kg increase in body weight versus baseline)
and without hypoglycemia (defined event per protocol).3
Analyses were based on a per-protocol population on treatment after two years
without the use of rescue medication (according to fasting plasma glucose and
A1C thresholds). A total of 504 patients were evaluable (233 linagliptin; 271
glimepiride). Baseline A1C levels were similar in the two groups (linagliptin,
7.2 percent and glimepiride, 7.3 percent).3 Six percent of linagliptin patients
experienced hypoglycemia versus 22 percent on glimepiride and 22 percent
experienced weight gain, versus 55 percent on glimepiride. Consequently, a
significantly higher proportion in the linagliptin group than with the
glimepiride group achieved the composite endpoint (54 percent versus 23
percent, respectively).
TRADJENTA is the first member of the dipeptidyl peptidase-4 (DPP-4) inhibitor
class to be approved at one dosage strength. Among many considerations when
treating patients with type 2 diabetes, approximately 40 percent of individuals
have some degree of renal impairment.5 With TRADJENTA, no dose adjustment is
required regardless of declining renal function or hepatic impairment.4 To
learn more about TRADJENTA and for full prescribing information visit:
www.TRADJENTA.com, or call Boehringer Ingelheim Pharmaceuticals, Inc. at
1-800-542-6257.
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).
It is not known if TRADJENTA is safe and effective when used with insulin.
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 medicine 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
breast-feeding or plan to breast-feed.
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.
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 Americans6 and an estimated 366 million people
worldwide7 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.6
Diabetes is a chronic disease that occurs when the body either does not
properly produce, or use, the hormone insulin.8
Boehringer Ingelheim and Eli Lilly and Company
In January 2011, Boehringer Ingelheim and Eli Lilly and Companyannounced an
alliance in the field of diabetes that centers on four 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 www.boehringer-ingelheim.com
or www.lilly.com.
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 http://us.boehringer-ingelheim.com and
follow us on Twitter at http://twitter.com/boehringerus.
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.
This press release contains forward-looking statements about TRADJENTA 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 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.
P-LLY
TJ232000
###
CONTACT:
Lara Crissey
Director of Communications and Public Relations
Boehringer Ingelheim Pharmaceuticals, Inc.
Email: usnews@boehringer-ingelheim.com
Phone: (203) 798-4740
Tammy Hull
Communications Manager
Lilly Diabetes
Email: hullta@lilly.com
Phone: (317) 651-9116
Press Release
For U.S. Media
Embargoed until June 9, 2012, 10:00 a.m. ET
Yki-Jarvinen H, Duran-Garcia S, Pinnetti S, et al. Efficacy and Safety of
Linagliptin as Add-On Therapy to Basal Insulin in Patients With Type 2
Diabetes. Abstract #999-P. Presented at the American Diabetes Association's
(ADA's) 72nd Scientific Sessions®. June 8-12, Philadelphia, PA.
Barnett A, Huisman H, Jones R, et al. Efficacy and Safety of Linagliptin in
Elderly Patients (=70 Years) With Type 2 Diabetes. Abstract #1017-P. Presented
at the American Diabetes Association's (ADA's) 72nd Scientific Sessions®. June
8-12, Philadelphia, PA.
3 Gallwitz B, Rosenstock J, Emser A, et al. Linagliptin is More Effective than
Glimepiride at Achieving a Composite Outcome of A1C Target with No Hypoglycemia
and No Weight Gain over two Years in Mildly Hyperglycemic Type 2 Diabetes
Patients on Metformin. Abstract #1044-P. Presented at the American Diabetes
Association's (ADA's) 72nd Scientific Sessions®. June 8-12, Philadelphia, PA.
4 Tradjenta® (linagliptin) tablets. Highlights of Prescribing Information.
Initial US Approval: 2011.
5 Plantinga LC, Crews DC, Coresh J; CDC CKD Surveillance Team. Prevalence of
chronic kidney disease in US adults with undiagnosed diabetes or prediabetes.
Clin J Am Soc Nephrol. 2010;5:673-682.
6 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.
7 International Diabetes Federation. Diabetes Atlas, 5th Edition: Fact Sheet.
2011.
8 International Diabetes Federation. IDF Diabetes Atlas, 5th Edition: What is
Diabetes? http://www.idf.org/diabetesatlas/5e/what-is-diabetes. Accessed on:
April 11, 2012.
END
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