INDIANAPOLIS, Feb. 26, 2018 /PRNewswire/ --
Trulicity® (dulaglutide) significantly improves A1C
(average blood sugar concentration over two to three months) when
added to ongoing treatment with a sodium-glucose co-transporter-2
(SGLT-2) inhibitor, according to results from AWARD-10, a new Phase
3b clinical study.1 These
data were published online first in The Lancet Diabetes &
Endocrinology. Trulicity is Eli Lilly and Company's (NYSE: LLY)
once-weekly, injectable glucagon-like peptide-1 (GLP-1) receptor
agonist approved to improve blood sugar (glucose) in adults with
type 2 diabetes. Trulicity should be used along with diet and
exercise.
"I've seen in my practice that even with effective oral
medicines like SGLT-2 inhibitors and metformin, many adults with
type 2 diabetes may still need additional therapy to maintain their
blood sugar levels," said Bernhard
Ludvik, M.D., associate professor of medicine,
Rudolfstiftung Hospital Vienna and AWARD-10 lead author. "The
AWARD-10 results suggest that the combination of once-weekly
Trulicity and an SGLT-2 inhibitor shows significant promise in
helping more people with type 2 diabetes reach their treatment
goals."
At the study's primary endpoint of 24 weeks, both Trulicity 1.5
mg and 0.75 mg added to ongoing treatment with an SGLT-2 inhibitor
demonstrated statistically superior glycemic control (-1.34
percent, -1.21 percent for Trulicity 1.5 mg and 0.75 mg,
respectively) compared to an SGLT-2 inhibitor with placebo (-0.54
percent). Further, significantly more people in the Trulicity
groups reached target A1C levels of less than 7 percent and less
than or equal to 6.5 percent:1
- Trulicity 1.5 mg: 71 percent (<7 percent); 50 percent (≤6.5
percent)
- Trulicity 0.75 mg: 60 percent (<7 percent); 38 percent (≤6.5
percent)
- Placebo: 32 percent (<7 percent); 14 percent (≤6.5
percent)
Additional results showed that Trulicity 1.5 mg combined with an
SGLT-2 inhibitor was associated with greater average weight loss
(-3.1 kg) compared to placebo (-2.1 kg). An average weight
reduction of -2.6 kg was seen in the Trulicity 0.75 mg group.
The most commonly reported adverse events associated with
Trulicity were gastrointestinal-related and consistent with
previous studies. Nausea (15 percent, 5 percent, 4 percent),
vomiting (4 percent, 3 percent, 1 percent) and diarrhea (6 percent,
10 percent, 3 percent) were more frequent in the Trulicity 1.5 mg
and 0.75 mg groups compared to placebo. One severe hypoglycemic
event was documented in the Trulicity 0.75 mg group. No new
Trulicity-related safety concerns were identified.1
"Managing type 2 diabetes with diet, exercise and oral
medications may require the addition of injectable therapy for some
people, given the progressive nature of the disease," said
Brad Woodward, M.D., senior medical
director, Lilly Diabetes. "AWARD-10 showed that Trulicity, when
used in combination with an SGLT-2 inhibitor and metformin, may be
effective and well tolerated in people with type 2 diabetes."
About the AWARD-10 Study
The Phase 3b, double-blind, parallel-arm,
placebo-controlled, 24-week AWARD-10 study compared the safety and
efficacy of Trulicity 1.5 mg and 0.75 mg in combination with sodium
glucose co-transporter-2 (SGLT-2) inhibitors to placebo plus SGLT-2
inhibitors in people with type 2 diabetes inadequately controlled
with SGLT-2 inhibitors, with or without metformin. The primary
objective of this study, in 424 patients in eight countries with a
mean baseline A1C of 8.04 percent, was to demonstrate superiority
of Trulicity plus an SGLT-2 inhibitor to placebo plus an SGLT-2
inhibitor on A1C reduction.
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 mellitus. 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 type 1 diabetes, people with
diabetic ketoacidosis, or people with a history of severe
gastrointestinal (GI) disease. It is not a substitute for insulin.
It has not been studied in children under 18 years of age.
Important Safety Information for
Trulicity®
Tell your healthcare provider if you get a lump or swelling
in your 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. Do not take Trulicity if you or any of your family members
have ever had MTC or if you have Multiple Endocrine Neoplasia
syndrome type 2 (MEN 2).
Do not take Trulicity if you have had an allergic reaction to
dulaglutide or any of the other ingredients in Trulicity.
Trulicity should not be used in children under 18 years of
age.
Trulicity may cause serious side effects, including:
- Inflammation of your pancreas (pancreatitis). If you
have pain in your stomach area (abdomen) that is severe and will
not go away, stop taking Trulicity and call your healthcare
provider right away. The pain may happen with or without vomiting.
It may be felt going from your abdomen through to your back.
- Low blood sugar (hypoglycemia). If you are using another
medicine that can cause low blood sugar (such as insulin or a
sulfonylurea) while taking Trulicity, your 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. Talk to your healthcare provider
about low blood sugar and how to manage it.
- Serious allergic reactions. Stop taking Trulicity and
get medical help right away if you have symptoms of a serious
allergic reaction including: swelling of your face, lips, tongue or
throat; problems breathing or swallowing; severe rash or itching;
fainting or feeling dizzy; or very rapid heartbeat.
- 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.
Tell your healthcare provider if you:
- have or have had problems with your pancreas, kidneys, or
liver.
- have severe problems with your stomach, such as slowed emptying
of your stomach (gastroparesis) or problems with digesting
food.
- have any other medical conditions.
- are pregnant or plan to become pregnant, or if you become
pregnant while taking Trulicity. It is not known if Trulicity will
harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if
Trulicity passes into your breast milk. You should not use
Trulicity while breastfeeding without first talking to your
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.
If you take too much Trulicity, call your healthcare provider or
go to the nearest emergency room right away.
The most common side effects with Trulicity may include:
nausea, diarrhea, vomiting, abdominal pain and decreased appetite.
Talk to your healthcare provider about any side effect that bothers
you or does not go away. These are not all the possible side
effects of Trulicity. Call your doctor for medical advice about
side effects.
You 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 CON ISI 24AUG2017
About Diabetes
Approximately 30 million
Americans2 and an estimated 425 million adults worldwide
have diabetes.3 Type 2 diabetes is the most common type
internationally, accounting for an estimated 90 to 95 percent of
all diabetes cases in the United
States alone.2 Diabetes is a chronic disease that
occurs when the body does not 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, collaboration and quality
manufacturing we strive to make life better for people affected by
diabetes. We offer a wide range of therapies and a continued
determination to provide real solutions—from medicines and
technologies to support programs and more. For the latest updates,
visit http://www.lillydiabetes.com/ or follow us on Twitter:
@LillyDiabetes and Facebook: LillyDiabetesUS.
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 added to SGLT-2 inhibitor treatment 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.
©LillyUSA, LLC 2018. All rights reserved.
Refer to:
|
Jennifer
Hoopingarner, jennifer.hoopingarner@lilly.com
|
|
317-741-8811, Lilly
Diabetes
|
References:
|
1.
|
Ludvik, Bernhard, MD,
Frias, Juan P., MD, et. al. Dulaglutide as add-on therapy to
SGLT2 inhibitors in patients with inadequately controlled type 2
diabetes (AWARD-10): a 24-week, randomised, double-blind,
placebo-controlled trial. The Lancet Diabetes &
Endocrinology. 2018: S2213-8587 (18) 30023-8. Retrieved from
http://www.thelancet.com/journals/landia/article/PIIS2213-8587(18)30023-8/fulltext?elsca1=tlxpr.
|
2.
|
Centers for Disease
Control and Prevention. National Diabetes Statistics Report, 2017.
Available at:
https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf.
November 2017.
|
3.
|
International
Diabetes Federation. IDF Diabetes Atlas, 8th edn, 2017. Available
at: http://www.diabetesatlas.org/. November 2017.
|
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SOURCE Eli Lilly and Company