INDIANAPOLIS, May 8, 2020 /PRNewswire/
-- New 36-week data showed higher investigational
doses of Trulicity (3 mg and 4.5 mg) were well-tolerated and led to
A1C reductions up to 1.9 percent and weight reductions up to 10.4
pounds in people with type 2 diabetes. The results from Eli Lilly
and Company's (NYSE: LLY) AWARD-11 trial – which evaluated the
safety and efficacy of higher investigational doses of Trulicity (3
mg and 4.5 mg) compared to Trulicity 1.5 mg – were published late
today in the Journal of the Endocrine Society.
"AWARD-11 confirmed our expectations that a higher
investigational dose of Trulicity would lead to superior blood
glucose and weight reductions in people with type 2 diabetes
compared to Trulicity 1.5 mg," said Juan
Pablo Frias, M.D., Medical Director and Principal
Investigator, National Research Institute. "These promising data
show higher doses of dulaglutide could be an option for clinicians
treating people with type 2 diabetes who may need additional
glycemic control due to the progressive nature of the
condition."
The 4.5 mg dose led to statistically superior A1C reductions
from baseline compared to Trulicity 1.5 mg across two primary
statistical approaches – efficacyi and
treatment-regimenii estimands – that were used to assess
the efficacy of the higher doses.
Using the efficacy estimand, which analyzes participants who
remained on treatment, dulaglutide 3 mg and 4.5 mg led to
significantly superior A1C and weight reductions from baseline
compared to Trulicity 1.5 mg:
Treatment
|
A1C
Reduction
(baseline 8.6
percent)
|
Weight
Reduction
[baseline 211.4
lbs. (95.9 kg)]
|
dulaglutide 4.5
mg
|
-1.9
percent*
|
-10.4 lbs. (-4.7
kg)*
|
dulaglutide 3
mg
|
-1.7
percent*
|
-8.8 lbs. (-4.0
kg)*
|
Trulicity 1.5
mg
|
-1.5
percent
|
-6.8 lbs. (-3.1
kg)
|
*Denotes statistical
significance compared to Trulicity 1.5 mg
|
In the treatment-regimen estimand, each of the doses led to
significant A1C and body weight reductions but only the 4.5 mg dose
showed superiority compared to Trulicity 1.5 mg:
- A1C reduction: -1.8 percent (dulaglutide 4.5 mg),
-1.6 percent (dulaglutide 3 mg) and -1.5 percent (Trulicity 1.5
mg).
- Weight reduction: -10.1 pounds (-4.6 kg,
dulaglutide 4.5 mg), -8.4 pounds (-3.8 kg, dulaglutide 3 mg) and
-6.6 pounds (-3.0 kg, Trulicity 1.5 mg).
Across both estimands, the majority of study participants
achieved target A1C goals of less than seven percent with the
higher investigational doses – meeting the American Diabetes
Association's recommendation for people with diabetes.
The safety and tolerability profile of the investigational
dulaglutide doses (3 mg and 4.5 mg) was consistent with the known
profile of Trulicity 1.5 mg. The most commonly reported adverse
events across each of the doses were gastrointestinal-related.
"Diabetes is a complex condition that progresses over time and
may require additional treatments to maintain blood glucose
control. That's why we studied higher doses of Trulicity, the most
prescribed GLP-1 receptor agonist in the U.S.," said Dawn Brooks, Ph.D., global development leader,
Trulicity, Lilly. "We are encouraged by these data and the
potential to provide people living with type 2 diabetes who may
need to advance their treatment with options that build on their
established experience with Trulicity."
Results at 52-weeks were consistent with the 36-week results and
further details will be disclosed at a later date. The AWARD-11
results have been submitted to regulatory authorities in the U.S.
and Europe for review.
About the AWARD-11 Study
The phase 3, randomized, double-blind, parallel arm study
included 1,842 participants with type 2 diabetes and evaluated the
efficacy and safety of two investigational doses of dulaglutide (3
mg and 4.5 mg) compared to Trulicity 1.5 mg. The primary objective
of the study was to demonstrate that a once-weekly investigational
dulaglutide dose (3 mg and/or 4.5 mg) was superior to the approved
Trulicity 1.5 mg dose, as measured by A1C reduction from baseline,
at 36 weeks in people with inadequately controlled type 2 diabetes
on concomitant metformin therapy. The primary and secondary
objectives could be met if one or both doses achieved statistical
significance for the endpoints. Secondary and exploratory outcomes
included change from baseline in mean body weight and fasting serum
glucose (FSG), percentage of patients reaching an A1C goal of less
than seven percent and occurrence of hypoglycemic episodes and
pharmacokinetics at steady-state through 36 and 52 weeks. All
participants started the study at a dose of Trulicity 0.75 mg
once-weekly and then increased the dose in a step-wise approach at
four week intervals to their final randomized maintenance dose of
once-weekly 1.5 mg, 3 mg (via a 1.5 mg step) or 4.5 mg (via steps
at 1.5 mg and 3 mg).
PURPOSE AND SAFETY SUMMARY WITH WARNINGS
Important Facts About Trulicity® (Trῡ-li-si-tee). It is
also known as dulaglutide.
TRULICITY is an injectable prescription medicine for adults with
type 2 diabetes used to improve blood sugar (glucose) and used to
reduce the risk of major cardiovascular events such as death, heart
attack, or stroke in people who have heart disease or multiple
cardiovascular risk factors.
- You take it once a week by injecting it under the skin of your
stomach, thigh, or upper arm. Use Trulicity together with the diet
and exercise that your doctor recommends. Trulicity is not
insulin.
Warnings
Trulicity may cause tumors in the thyroid, including thyroid
cancer. Watch for possible symptoms, such as a lump or swelling in
the neck, trouble swallowing, hoarseness, or shortness of breath.
If you have a symptom, tell your doctor.
- Do not use Trulicity if you or any of your family have ever had
a type of thyroid cancer called medullary thyroid carcinoma
(MTC).
- Do not use Trulicity if you have Multiple Endocrine Neoplasia
syndrome type 2 (MEN 2).
- Do not use Trulicity if you are allergic to dulaglutide or
other ingredients in Trulicity.
Ask your doctor how to recognize the serious side effects below
and what to do if you think you have one:
Inflamed pancreas (pancreatitis). Stop using Trulicity
and call your healthcare provider right away if you have severe
pain in your stomach area (abdomen), with or without vomiting, that
will not go away. You may feel the pain from your abdomen to your
back.
Changes in vision. Tell your healthcare provider if
you have changes in vision during treatment with Trulicity.
Low blood sugar (hypoglycemia). Signs and symptoms of low
blood sugar may include dizziness or light-headedness, confusion or
drowsiness, headache, blurred vision, slurred speech, fast
heartbeat, sweating, hunger, shakiness, feeling jittery, weakness,
anxiety, irritability or mood changes.
Serious allergic reactions. Stop using Trulicity and get
medical help right away if you have any symptoms of a serious
allergic reaction which may include: swelling of your face, lips,
tongue or throat, problems breathing or swallowing, severe rash or
itching, fainting or feeling dizzy, or very rapid heartbeat.
Acute kidney injury. 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.
Common side effects
The most common side effects of Trulicity include nausea,
diarrhea, vomiting, abdominal pain and decreased appetite.
These are not all the possible side effects of Trulicity.
Tell your doctor if you have any side effects. You can report
side effects at 1-800-FDA-1088 or
www.fda.gov/medwatch.
Before using
- Your healthcare provider should show you how to use
Trulicity before you use it for the first time.
-
Before you use Trulicity, talk to your doctor about low blood sugar and how to manage it.
Review these
questions with your doctor:
- Do you have other medical conditions,
including problems with your pancreas, kidneys,
liver, or stomach, or have a history of diabetic
retinopathy?
- Do you take other diabetes medicines,
such as insulin or sulfonylureas?
- Do you take any other
prescription medicines or over-the-counter drugs, vitamins
or herbs?
Review the list below with your doctor. Trulicity may not be
right for you if:
- You are pregnant or plan to become pregnant or
breastfeeding or plan to breastfeed.
-
You have type 1 diabetes or diabetic ketoacidosis.
- You have or have had an inflamed pancreas
(pancreatitis).
- You have severe intestinal or stomach problems, such as slowed
emptying or problems with digesting food.
- You are a child under 18 years old.
How to take
- Read the Instructions for Use that come with Trulicity.
- Use Trulicity exactly as your doctor says.
- Do not share your Trulicity pen, syringe or needles with
another person.
- Do not give Trulicity to other people.
- If you take too much Trulicity, call your healthcare provider
or seek medical advice promptly.
Learn more
For more information, call 1-844-TRU-INFO (1-844-878-4636) or go
to www.TRULICITY.com.
This summary provides basic information
about Trulicity but does not include all information
known about this medicine. Read the information that comes
with your prescription each time
your prescription is filled. This information does not take the place of talking with your doctor. Be sure to
talk to your doctor or other healthcare provider about Trulicity and how to take it.
Your doctor is the best person to help you decide if
Trulicity is right for you.
Trulicity® is a registered trademark owned or
licensed by Eli Lilly and Company, its subsidiaries, or
affiliates.
DG CON BS FEB2020
About Diabetes
Approximately 34 million
Americans1 (just over 1 in 10) and an estimated 463
million adults worldwide2 have diabetes. 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 alone1. 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 and related conditions. We work to deliver breakthrough
outcomes through innovative 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 lilly.com and
lilly.com/newsroom. 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 dulaglutide 3 mg and/or 4.5 mg as a potential treatment
for people with type 2 diabetes and reflects Lilly's current
belief. 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 the
results to date or that dulaglutide 3 mg and/or 4.5 mg will receive
regulatory approvals. 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.
1 Centers for Disease Control and Prevention.
National Diabetes Statistics Report, 2020. Atlanta, GA: Centers for Disease Control and
Prevention, U.S. Dept. of Health and Human Services; 2020.
2 International Diabetes Federation. IDF
Diabetes Atlas, 9th edn. Brussels, Belgium: International Diabetes
Federation, 2019. Available at: http://diabetesatlas.org.
i The efficacy estimand was used to evaluate results
in participants who stayed on treatment and did not start another
diabetes medicine throughout the trial.
ii The treatment-regimen estimand, conducted based on
regulatory guidance, includes data from all participants through
the end of the trial, which may include confounding effects of
rescue medication or discontinuation from the study drug or the
trial.
Refer to:
|
Dani Barnhizer;
dbarnhizer@lilly.com; 317-607-6119 (Lilly Diabetes)
|
|
Kevin Hern;
hern_kevin_r@lilly.com; 317-277-1838 (Investors)
|
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