INDIANAPOLIS, June 12, 2016 /PRNewswire/ -- New data from
a completed Phase 3 trial show Trulicity® (dulaglutide)
1.5 mg significantly reduced hemoglobin A1c (A1C) and body weight
as an add-on to insulin glargine without increasing the risk of low
blood sugar after 28 weeks compared to placebo plus insulin
glargine. Trulicity is Eli Lilly and Company's (NYSE: LLY)
once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist that
is used along with diet and exercise for the treatment of type 2
diabetes. Data from the Trulicity AWARD-9 trial were presented
today at the 76th American Diabetes Association
Scientific Sessions (ADA) in
New Orleans, Louisiana.
"Some people with type 2 diabetes require the use of more than
one therapy to reach their glucose management goals and as a
result, there is a concern about the risk of causing low sugar
levels," said Paolo Pozzilli, M.D., professor of endocrinology and
metabolic diseases at University Campus Bio-Medico in Rome,
Italy and lead author. "AWARD-9
demonstrates that Trulicity may help people with diabetes who
continue to experience inadequate glycemic control on insulin
glargine alone reach their treatment goals."
Lilly's AWARD program has consistently shown Trulicity's
efficacy in improving glycemic control. Data from AWARD-9 builds on
the available data, demonstrating Trulicity's viability for use in
combination with insulin glargine to help people with type 2
diabetes reach treatment goals.
After 28 weeks of treatment, Trulicity 1.5 mg plus insulin
glargine significantly reduced A1C from baseline (1.44 percent)
compared to placebo with insulin glargine (0.67 percent). Also:
- Significantly more people treated with Trulicity 1.5 mg plus
insulin glargine achieved an A1C of less than 7 percent (69.3
percent) compared to placebo with insulin glargine (35.1
percent);
- The group treated with Trulicity 1.5 mg plus insulin glargine
saw significant reductions in fasting serum glucose levels (the
amount of sugar in the blood in a fasting state) with a 44.63 mg/dL
reduction compared to the group treated with placebo plus insulin
glargine (27.90 mg/dL reduction); and
- Study participants treated with Trulicity 1.5 mg experienced
significant weight loss (-1.91 kg) compared to participants treated
with placebo plus insulin glargine, who gained weight (0.50
kg).
- During the course of the study, insulin glargine was titrated
using a treat-to-target algorithm in both groups; after 28 weeks,
participants treated with Trulicity 1.5 mg took an average of 13.19
units less of insulin glargine than those treated with placebo plus
insulin glargine (51.42 vs. 64.61 U).
The most commonly reported adverse events for people taking
Trulicity in AWARD-9 were gastrointestinal-related and consistent
with prior Trulicity studies, including nausea (12 percent) and
diarrhea (11.3 percent). Hypoglycemia rates were similar in the
Trulicity 1.5 mg plus insulin glargine group (7.69
events/patient/year) compared to those treated with placebo plus
insulin glargine (8.56 events/patient/year). One severe
hypoglycemic event was documented in the Trulicity 1.5 mg plus
insulin glargine group.
"Despite best efforts to manage their A1C with diet and oral
agents, many people with type 2 diabetes transition to injectable
therapy as a natural part of the disease progression," said
Zvonko Milicevic, senior medical
fellow, Lilly Diabetes. "For people with type 2 diabetes who are
inadequately controlled on insulin glargine alone, AWARD-9
may show that Trulicity is a treatment option that could
significantly reduce A1C when used in combination with their
current insulin therapy."
About the AWARD-9 Study
This Phase 3, randomized,
double-blind, placebo-controlled, 28-week study evaluated the
efficacy and safety of once-weekly Trulicity (dulaglutide) 1.5 mg
as an add-on to insulin glargine compared to placebo with insulin
glargine. The primary objective of this study, in 300 patients in
five countries with a mean baseline A1C of 8.4 percent, was to
demonstrate superiority of Trulicity 1.5 mg to placebo on A1C
reduction in type 2 diabetes patients inadequately treated with
insulin glargine, with or without metformin.
Indication and Limitations of Use for Trulicity
Trulicity is a once-weekly injectable prescription medicine to
improve blood sugar (glucose) in adults with type 2 diabetes. It
should be used along with diet and exercise.
Trulicity is not recommended as the first medication to treat
diabetes. It has not been studied in people who have had
inflammation of the pancreas (pancreatitis). Trulicity should not
be used by people with a history of severe gastrointestinal (GI)
disease, people with type 1 diabetes, or people with diabetic
ketoacidosis. It is not a substitute for insulin. It has not been
studied with long-acting insulin or in children under 18 years of
age.
Important Safety Information for
Trulicity®
Patients should tell their healthcare provider if they get a
lump or swelling in their neck, have hoarseness, trouble
swallowing, or shortness of breath while taking Trulicity. These
may be symptoms of thyroid cancer. In studies with rats or mice,
Trulicity and medicines that work like Trulicity caused thyroid
tumors, including thyroid cancer. It is not known if Trulicity will
cause thyroid tumors or a type of thyroid cancer called medullary
thyroid carcinoma (MTC) in people. Patients should not take
Trulicity if they or any of their family members have ever had MTC
or if they have Multiple Endocrine Neoplasia syndrome type 2 (MEN
2).
Patients should not take Trulicity if they have had an allergic
reaction to dulaglutide or any of the other ingredients in
Trulicity.
Trulicity may cause serious side effects, including:
- Inflammation of the pancreas (pancreatitis). If a
patient has pain in their stomach area (abdomen) that is severe and
will not go away, they should stop taking Trulicity and call their
healthcare provider right away. The pain may happen with or without
vomiting. It may be felt going from the abdomen through to the
back.
- Low blood sugar (hypoglycemia). If patients are using
another medicine that can cause low blood sugar (such as insulin or
a sulfonylurea) while taking Trulicity, their risk for getting low
blood sugar (hypoglycemia) may be higher. Signs and symptoms of low
blood sugar may include dizziness, blurred vision, anxiety,
irritability, mood changes, sweating, slurred speech, hunger,
confusion or drowsiness, shakiness, weakness, headache, fast
heartbeat, or feeling jittery. Patients should talk to their
healthcare provider about low blood sugar and how to manage
it.
- Serious allergic reactions. Patients should stop taking
Trulicity and get medical help right away if they have symptoms of
a serious allergic reaction, such as itching, rash, or difficulty
breathing.
- Kidney problems (kidney failure). In people who have
kidney problems, diarrhea, nausea, and vomiting may cause a loss of
fluids (dehydration). This may cause kidney problems to get
worse.
- Severe stomach problems. Trulicity may cause stomach
problems, which could be severe.
Patients should tell their healthcare provider if
they:
- have or have had problems with their pancreas, kidneys, or
liver.
- have severe problems with their stomach, such as slowed
emptying of the stomach (gastroparesis) or problems with digesting
food.
- have any other medical conditions.
- are pregnant or plan to become pregnant, or if they become
pregnant while taking Trulicity. It is not known if Trulicity will
harm their unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if
Trulicity passes into breast milk. Patients should not use
Trulicity while breastfeeding without first talking to their
healthcare provider.
- are taking other medicines including prescription and
over-the-counter medicines, vitamins, and herbal supplements.
Trulicity may affect the way some medicines work and some medicines
may affect the way Trulicity works.
- are taking other medicines to treat diabetes, including insulin
or sulfonylureas.
The most common side effects with Trulicity may include:
nausea, diarrhea, vomiting, decreased appetite, and indigestion.
Patients should talk to their healthcare provider about any side
effect that bothers them or does not go away. These are not all the
possible side effects of Trulicity. Patients should call their
doctor for medical advice about side effects.
Patients are encouraged to report side effects of prescription
drugs to the FDA. Visit www.fda.gov/medwatch or call
1-800-FDA-1088.
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 PR ISI 24SEP2015
About Diabetes
Approximately 29 million
Americans1 and an estimated 415 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. Diabetes is a chronic disease
that occurs when the body does not either properly produce or use
the hormone insulin.1
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 are building upon this heritage by
working to meet the diverse needs of people with diabetes and those
who care for them. Through research and collaboration, a broad and
growing product portfolio and a continued determination to provide
real solutions—from medicines to support programs and more—we
strive to make life better for all those affected by diabetes
around the world. For more information, visit www.lillydiabetes.com
or follow us on Twitter: @LillyDiabetes.
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 registered trademark owned or
licensed by Eli Lilly and Company, its subsidiaries, or
affiliates.
This press release contains forward-looking statements (as
that term is defined in the Private Securities Litigation Reform
Act of 1995) about Trulicity as a treatment of type 2 diabetes,
along with diet and exercise, and Lilly's current beliefs. However,
as with any pharmaceutical product, there are substantial risks and
uncertainties in the process of development and commercialization.
Among other things, there can be no guarantee that future study
results will be consistent with study findings to date, that
Trulicity will receive additional regulatory approvals or that
Trulicity will prove to be commercially successful. For further
discussion of these and other risks and uncertainties, see Lilly's
most recent Form 10-K and Form 10-Q filings with the United States
Securities and Exchange Commission. Except as required by law,
Lilly undertakes no duty to update forward-looking statements to
reflect events after the date of this release.
References
1 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.
2 International Diabetes Federation. IDF Diabetes
Atlas, 7th edn. Brussels,
Belgium: International Diabetes Federation, 2015.
http://www.idf.org/diabetesatlas.
Refer to: Greg Kueterman,
kueterman_gregory_andrew@lilly.com, 317-277-4021
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