INDIANAPOLIS, June 8, 2015 /PRNewswire/
-- Trulicity™ 1.5 mg and 0.75 mg provided superior
hemoglobin A1c (A1C) reduction compared to Lantus® in a
study of patients with type 2 diabetes and primarily enrolled from
East Asia, according to new data
presented by Eli Lilly and Company (NYSE: LLY). The
head-to-head study was presented today at the 75th
American Diabetes Association (ADA) Scientific Sessions in
Boston.1
"Continuing to research our medicines beyond the initial
clinical trial program is important for patients and for the
ongoing study of diabetes," said Brad
Woodward, M.D., senior medical director, Lilly Diabetes.
"These results reinforce the value, safety and efficacy of
once-weekly Trulicity for people in need of additional treatment
when diet, exercise and oral medicines are not enough to give them
the blood sugar control they need."
After 26 weeks, both doses of Trulicity were superior to Lantus
in A1C reduction, and significantly more patients reached the
recommended A1C target of less than 7 percent.
- A1C reductions from baseline: -1.7 percent (Trulicity 1.5 mg),
-1.32 percent (Trulicity 0.75 mg), -1.15 percent (Lantus).
- Percentages of patients reaching target A1C levels (< 7
percent): 65 percent (Trulicity 1.5 mg), 54 percent (Trulicity 0.75
mg), 41 percent (Lantus).1
Patients treated with Trulicity 1.5 mg and 0.75 mg also lost an
average of 1.51 kg and 0.88 kg respectively, while patients treated
with Lantus gained 0.96 kg.1
Trulicity was well-tolerated in the study, showing fewer reports
of hypoglycemia in patients treated with Trulicity 1.5 mg and 0.75
mg compared to Lantus. No severe hypoglycemia was reported. Other
adverse events were gastrointestinal in nature, with more
Trulicity-treated patients experiencing diarrhea (15.2 percent
[Trulicity 1.5 mg], 8.4 percent [Trulicity 0.75 mg]) and nausea
(8.7 percent [Trulicity 1.5 mg], 4.9 percent [Trulicity 0.75 mg])
compared to Lantus (1.6 percent [diarrhea] and 0.8 percent
[nausea]). These results were consistent with previous Trulicity
studies.1
Trulicity was approved by the U.S. Food and Drug Administration
(FDA) in September 2014, and launched in the U.S. in November 2014.
The European Commission granted marketing authorisation for
Trulicity in November 2014, and launches are ongoing in the various
countries. Additional regulatory applications are pending around
the world.
About the study
This randomized, open-label,
parallel-arm study compared the safety and efficacy of Trulicity
1.5 mg and 0.75 mg to Lantus. The primary objective of the study,
conducted in 789 type 2 diabetes patients inadequately controlled
on metformin and/or a sulfonylurea, was to evaluate whether
Trulicity 1.5 mg was non-inferior to Lantus in reducing A1C from
baseline at 26 weeks. The study enrolled participants primarily
from China and also from Korea,
Mexico and Russia. Participants had an average baseline
A1C of 8.36 percent and continued to receive background treatment
of metformin and/or a sulfonylurea.1
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 the
uncertain relevance of 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.
|
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
Americans2 and an estimated 387 million people worldwide
have type 1 and type 2 diabetes. Type 2 diabetes is the most common
type, accounting for an estimated 90 to 95 percent of all diabetes
cases. Diabetes is a chronic disease that occurs
when the body either does not properly produce, or use, the hormone
insulin. 3
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
Trulicity™ is a trademark of Eli Lilly and
Company.
Lantus® is a registered trademark of Sanofi.
This press release contains forward-looking statements about
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 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.
1 Gu L, Wang W, Nevarez Ruiz L, et. al. 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. Abstract 280-OR. Presented at
75th American Diabetes Association (ADA) Scientific
Sessions; June 5-9, 2015;
Boston, MA.
2 Centers for Disease Control and Prevention.
National Diabetes Statistics Report, 2014. Available
at:
http://www.cdc.gov/diabetes/pubs/statsreport14/national-diabetes-report-web.pdf.
October 2014.
3 International Diabetes Federation. IDF Diabetes
Atlas, 6th edn. Brussels,
Belgium: International Diabetes Federation, 2014.
http://www.idf.org/diabetesatlas.
Refer to: Candace Johnson,
johnson_candace_a@lilly.com, (317) 755-9143
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