INDIANAPOLIS, May 27, 2015 /PRNewswire/ -- New clinical
data demonstrating the range of treatment options represented in
Lilly's (NYSE: LLY) diabetes portfolio will be presented in 79
abstracts on June 5-9, at the
75th American Diabetes Association (ADA)®
Scientific Sessions in Boston. These presentations reflect Lilly's
efforts to enhance scientific knowledge and improve current
approaches to diabetes management. Thirty-five of the abstracts
will be presented as part of the Boehringer Ingelheim-Lilly
Diabetes alliance.
"The Scientific Sessions are an important opportunity for
researchers and healthcare and industry professionals to come
together and share learnings and advances in diabetes care," said
David Kendall, M.D., vice president
of Medical Affairs, Lilly Diabetes. "We look forward to
communicating significant new data that showcase the full range of
our diabetes portfolio."
Among the data being presented at this year's Scientific
Sessions are:
Basal Insulin Peglispro
Lilly will share new efficacy
and safety data for its investigational basal insulin peglispro
(BIL), including two late-breaking abstracts and the first data
presentations from the seven Phase III IMAGINE trials in patients
with type 1 and type 2 diabetes. A total of 19 abstracts will be
presented, including three oral presentations:
- Saturday, June 6, 1:45 to 3:45 p.m., "Basal Insulin Analogs: New
Evidence" Oral Session
- 1:45 p.m.: Basal Insulin
Peglispro (BIL) is Superior to Insulin Glargine (GL) in Reducing
HbA1c at 52 Weeks in Insulin-Naïve T2D Patients (Pts) Treated with
Oral Antihyperglycemic Medications (OAMs): IMAGINE 2 (Lead author:
M.J. Davies) [Presentation No.
93-OR]
- 2 p.m.: Reduced Intra-subject
Variability of Basal Insulin Peglispro (BIL) Compared to Insulin
Glargine in Patients with Type 1 Diabetes Mellitus (T1DM) (Lead
author: T. Heise) [Presentation No. 94-OR]
- 2:15 p.m.: Greater HbA1c
Reduction with Basal Insulin Peglispro (BIL) v Insulin Glargine
(GL) in an Open-label, Randomized Study in T1D Patients (pts):
IMAGINE 1 (Lead author: S. K. Garg)
[Presentation No. 95-OR]
Additional data showing BIL's effect on hypoglycemia, liver
enzymes and lipids will also be presented.
Trulicity™ (dulaglutide)
Lilly will present nine abstracts for Trulicity, a once-weekly,
glucagon-like peptide-1 receptor agonist (GLP-1 RA) injectable
prescription medication to improve blood sugar in adults with type
2 diabetes along with diet and exercise. Among these presentations
are new data comparing the safety and efficacy of Trulicity to
other common diabetes medicines in multinational patient
populations, and a meta-analysis showing no increased risk of
cardiovascular events in patients taking Trulicity. Select
presentations are as follows:
- Saturday, June 6, 11:30 a.m. to 1:30 p.m., General Poster
Session
- Efficacy and Safety of Once-weekly Dulaglutide versus
Once-daily Liraglutide in Japanese Patients with Type 2 Diabetes
(Lead author: T. Takamura) [Poster No. 1111-P]
- Once Weekly Dulaglutide Does Not Increase the Risk for CV
Events in Type 2 Diabetes: A Pre-Specified CV Meta-Analysis of
Prospectively Adjudicated CV Events (Lead author: K.C. Ferdinand) [Poster No. 1127-P]
- Monday, June 8, 8 a.m. to 10 a.m., "Update on GLP-1 Receptor
Agonists" Oral Session
- Efficacy and Safety of Once-Weekly Dulaglutide vs. Insulin
Glargine in Combination with Metformin and/or a Sulfonylurea in
Predominantly Asian Patients with Type 2 Diabetes (Lead author: W.
Wang) [Presentation No. 280-OR]
For more information on presentations, please click here.
About Trulicity
Trulicity is a once-weekly,
glucagon-like peptide-1 receptor agonist (GLP-1 RA) injectable
prescription medicine indicated as an adjunct to diet and exercise
to improve glycemic control in adults with type 2 diabetes.
Trulicity is not insulin. It acts like GLP-1, a natural hormone,
helping the body release its own insulin when patients eat to
control blood sugar.
Trulicity comes in a pen and does not require the patient to
mix, measure, or handle the needle. It can be taken any time of
day, with or without meals, and should be injected subcutaneously
in the abdomen, thigh, or upper arm.
Indication and Limitations of Use for Trulicity
Trulicity is indicated as an adjunct to diet and exercise to
improve glycemic control in adults with type 2 diabetes.
Trulicity is not recommended as first-line therapy for patients
inadequately controlled on diet and exercise because of uncertain
relevance in rodent C-cell tumor findings to humans. Prescribe only
if potential benefits outweigh potential risks. It has not been
studied in patients with a history of pancreatitis, and other
antidiabetic therapies should be considered. Trulicity is not for
the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.
Trulicity is not a substitute for insulin and has not been studied
in combination with basal insulin. Trulicity has not been studied
in patients with severe gastrointestinal disease, including severe
gastroparesis, and is not for patients with pre-existing severe
gastrointestinal disease.
Important Safety Information for
Trulicity™
WARNING:
RISK OF THYROID C-CELL TUMORS
In male and female rats, dulaglutide causes a dose-related and
treatment-duration-dependent increase in the incidence of thyroid
C-cell tumors (adenomas and carcinomas) after lifetime exposure. It
is unknown whether Trulicity causes thyroid C-cell tumors,
including medullary thyroid carcinoma (MTC), in humans as human
relevance of dulaglutide-induced rodent thyroid C-cell tumors has
not been determined.
Trulicity is contraindicated in patients with a personal or family
history of MTC and in patients with Multiple Endocrine Neoplasia
syndrome type 2 (MEN 2). Counsel patients regarding the potential
risk of MTC with use of Trulicity and inform them of symptoms of
thyroid tumors (e.g., mass in the neck, dysphagia, dyspnea,
persistent hoarseness). Routine monitoring of serum calcitonin or
using thyroid ultrasound is of uncertain value for early detection
of MTC in patients treated with Trulicity.
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Trulicity is contraindicated in patients with a personal or
family history of MTC or in patients with MEN 2, and in patients
with a prior serious hypersensitivity reaction to dulaglutide or
any of the product components.
Risk of Thyroid C-cell Tumors: Cases of MTC in patients
treated with liraglutide, another GLP-1 receptor agonist (GLP-1
RA), have been reported in the postmarketing period; the data in
these reports are insufficient to establish or exclude a causal
relationship between MTC and GLP-1 RA use in humans. If serum
calcitonin is measured and found to be elevated or thyroid nodules
are noted on physical examination or neck imaging, the patient
should be further evaluated.
Pancreatitis: Has been reported in clinical trials.
Observe patients for signs and symptoms including persistent severe
abdominal pain. If pancreatitis is suspected, discontinue Trulicity
promptly. Do not restart if pancreatitis is confirmed. Consider
other antidiabetic therapies in patients with a history of
pancreatitis.
Hypoglycemia: The risk of hypoglycemia is increased when
Trulicity is used in combination with insulin secretagogues (e.g.,
sulfonylureas) or insulin. Patients may require a lower dose of the
sulfonylurea or insulin to reduce the risk of hypoglycemia.
Hypersensitivity Reactions: Systemic reactions were
observed in patients receiving Trulicity in clinical trials.
Instruct patients who experience symptoms to discontinue Trulicity
and promptly seek medical advice.
Renal Impairment: In patients treated with GLP-1
RAs, there have been postmarketing reports of acute renal failure
and worsening of chronic renal failure, sometimes requiring
hemodialysis. A majority of reported events occurred in patients
who had experienced nausea, vomiting, diarrhea, or dehydration. In
patients with renal impairment, use caution when initiating or
escalating doses of Trulicity and monitor renal function in
patients experiencing severe adverse gastrointestinal
reactions.
Severe Gastrointestinal Disease: Use of Trulicity may be
associated with gastrointestinal adverse reactions, sometimes
severe. Trulicity has not been studied in patients with severe
gastrointestinal disease, including severe gastroparesis, and is
therefore not recommended in these patients.
Macrovascular Outcomes: There have been no clinical
studies establishing conclusive evidence of macrovascular risk
reduction with Trulicity or any other antidiabetic drug.
The most common adverse reactions reported in ≥5% of
Trulicity-treated patients in placebo-controlled trials (placebo,
Trulicity 0.75 mg, and Trulicity 1.5 mg) were nausea (5.3%, 12.4%,
21.1%), diarrhea (6.7%, 8.9%, 12.6%), vomiting (2.3%, 6.0%, 12.7%),
abdominal pain (4.9%, 6.5%, 9.4%), decreased appetite (1.6%, 4.9%,
8.6%), dyspepsia (2.3%, 4.1%, 5.8%), and fatigue (2.6%, 4.2%,
5.6%).
Gastric emptying is slowed by Trulicity, which may impact
absorption of concomitantly administered oral medications. Use
caution when oral medications are used with Trulicity. Drug levels
of oral medications with a narrow therapeutic index should be
adequately monitored when concomitantly administered with
Trulicity. In clinical pharmacology studies, Trulicity did not
affect the absorption of the tested, orally administered
medications to a clinically relevant degree.
Pregnancy: There are no adequate and well-controlled
studies of Trulicity in pregnant women. Use only if potential
benefit outweighs potential risk to fetus.
Nursing Mothers: It is not known whether Trulicity is
excreted in human milk. A decision should be made whether to
discontinue nursing or to discontinue Trulicity, taking into
account the importance of the drug to the mother.
Pediatric Use: Safety and effectiveness of Trulicity have
not been established and use is not recommended in patients less
than 18 years of age.
Please click to access Prescribing
Information, including Boxed Warning about possible thyroid
tumors including thyroid cancer, and Medication
Guide.
Please see Instructions for Use included with the
pen.
DG HCP ISI 20APR2015
About Diabetes
Approximately 29 million
Americans[1] and an estimated 387 million people
worldwide have type 1 and type 2
diabetes.[2] Type 2 diabetes is the most
common type, accounting for an estimated 90 to 95 percent of all
diabetes cases.[1] Diabetes is a chronic disease that
occurs when the body either does not properly produce, or use, the
hormone insulin.[2]
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.
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.
P-LLY
This press release contains forward-looking statements about
an investigational compound basal insulin peglispro, which is
currently in development for the treatment of diabetes and
Trulicity 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 basal insulin
peglispro will receive required regulatory approvals or that
Trulicity will 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.
___________________________
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[1]
Centers for Disease Control and Prevention. National Diabetes
Statistics Report: Estimates of Diabetes and Its Burden in the
United States, 2014. Atlanta, GA: U.S. Department of Health and
Human Services; 2014.
|
[2]
International Diabetes Federation. IDF Diabetes Atlas, 6th edn.
Brussels, Belgium: International Diabetes Federation, 2014.
http://www.idf.org/diabetesatlas.
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Refer to: Candace Johnson,
johnson_candace_a@lilly.com, (317) 755-9143
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SOURCE Eli Lilly and Company