INDIANAPOLIS, Feb. 8, 2017 /PRNewswire/ -- The label for Eli
Lilly and Company's (NYSE: LLY) once-weekly Trulicity®
(dulaglutide) is now updated to include use in combination with
basal insulin for adults with type 2 diabetes. The U.S. Food and
Drug Administration (FDA) included the changes to the approved
product labeling to reflect this important information for
prescribers. Trulicity is available in a prefilled pen in 0.75 and
1.5 mg doses.
"Despite best efforts to manage their A1C, many adults with type
2 diabetes may need to add to or change their treatment plan to
help them reach their blood sugar goals," said Sherry Martin, M.D., vice president, Global
Medical Affairs, Lilly Diabetes. "They now have the option to use
Trulicity, with its powerful efficacy in a once-weekly, easy-to-use
pen,* along with basal insulin for even greater control."
Trulicity is a once-weekly glucagon-like peptide-1 (GLP-1)
receptor agonist 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). It is not a substitute
for insulin. Trulicity should not be used by people with type 1
diabetes, people with diabetic ketoacidosis, or people with a
history of severe stomach or intestinal problems. It has not been
studied in children under 18 years of age.
Trulicity has a Boxed Warning about potential thyroid tumors,
including cancer. It should not be taken by someone with a
personal or family history of medullary thyroid cancer, a personal
history of Multiple Endocrine Neoplasia syndrome type 2, or an
allergy to Trulicity.
The Trulicity label update is based on FDA review of results
from the AWARD-9 clinical trial, a Phase 3b, randomized,
double-blind, placebo-controlled, 28-week study that evaluated the
efficacy and safety of once-weekly Trulicity 1.5 mg as an add-on to
titrated insulin glargine, with or without metformin, compared to
placebo as an add-on to titrated insulin glargine, with or without
metformin.1 Study results showed that Trulicity 1.5 mg
significantly reduced A1C as an add-on to insulin glargine (1.4
percent) after 28 weeks compared to placebo plus insulin glargine
(0.7 percent).
The label was also updated to include results from the AWARD-8
clinical trial, a Phase 3b randomized, double-blind,
placebo-controlled, 24-week study that evaluated the efficacy and
safety of Trulicity 1.5 mg as an add-on to sulfonylurea compared to
placebo plus sulfonylurea.2
Trulicity was first approved in September
2014 as a once-weekly injectable prescription medicine to
improve blood sugar (glucose) in adults with type 2 diabetes, based
in part on results from five Phase 3 studies of Trulicity used
alone or in combination with other diabetes medications, including
metformin, pioglitazone, glimepiride and insulin lispro. With this
update, Trulicity is the first and only GLP-1 receptor agonist with
a label that allows its use in combination with mealtime insulin or
basal insulin.
*In a usability study, 94 percent of people said the pen was
easy to use. Patients should read the Instructions for Use included
with their pen.
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
Americans3 and an estimated 415 million people worldwide
have type 1 and type 2 diabetes.4 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 disease
that occurs when the body does not either properly produce or use
the hormone insulin.
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 wide range
of therapies 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.
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
www.lilly.com/newsroom/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.
PP-DG-US-0716 2/2017 ©LillyUSA, LLC 2017. All rights reserved.
1 Pozzilli P, Norwood P, Jodar E, et. al.
Improved Glycemic Control and Weight Loss with Once Weekly
Dulaglutide versus Placebo, Both Added to Titrated Daily Insulin
Glargine, in Type 2 Diabetes Patients (AWARD-9). Data presented at
76th American Diabetes Association Scientific Sessions,
New Orleans, LA.
2 Dungan, K, Weitgasser R, Manghi FP, et. al.
Efficacy and Safety of Once Weekly Dulaglutide Added on to
Sulfonylurea in Type 2 Diabetes (AWARD-8). Abstract 0219-PD.
Presented at 2015 International Diabetes Federation (IDF) World
Congress; 30 November – 4 December, Vancouver, Canada.
3 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.
4 International Diabetes Federation. IDF Diabetes
Atlas, 7th edn. Brussels,
Belgium: International Diabetes Federation, 2015.
http://www.idf.org/diabetesatlas.
Refer to:
Jennifer Hoopingarner,
jennifer.hoopingarner@lilly.com,
317-741-8811, Lilly Diabetes
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SOURCE Eli Lilly and Company