- Jardiance® (empagliflozin) is the first SGLT2
inhibitor to demonstrate a statistically significant reduction in
the primary outcome of HbA1c (a marker of average blood sugar) in
participants aged 10-17 living with type 2 diabetes compared to
placebo
- Safety data in this vulnerable population was similar to that
in adults with type 2 diabetes, confirming the well-established
safety profile of Jardiance
INGELHEIM, Germany and RIDGEFIELD, Conn. and INDIANAPOLIS, Dec. 7, 2022
/PRNewswire/ -- The DINAMO phase III clinical trial met its primary
endpoint by demonstrating a statistically significant reduction in
HbA1c (a marker of average blood sugar) with Jardiance®
(empagliflozin) compared with placebo for children and adolescents
aged 10-17 years living with type 2 diabetes. When Jardiance was
added to other baseline treatments (diet, exercise, metformin
and/or insulin) HbA1c was reduced by 0.84% compared with placebo at
week 26 (95% CI –1.50 to –0.19; P=0.012). The results were
presented today at the International Diabetes Federation (IDF)
World Diabetes congress 2022, Boehringer Ingelheim and Eli Lilly
and Company (NYSE: LLY) announced.
The DINAMO (DIabetes study of liNAgliptin and eMpagliflozin in
children and adOlescents) trial included youth aged 10-17 years
with type 2 diabetes and HbA1c ≥6.5% and ≤10.5%. Participants were
randomly assigned treatment with Jardiance (10 or 25 mg) (n=52),
Tradjenta® (linagliptin) (5 mg) (n=53) or placebo (n=53)
once daily. All participants were treated with diet and exercise
plus, when appropriate, metformin and/or insulin.
The overall safety data was generally consistent with previous
findings in adults with type 2 diabetes, confirming the
well-established safety profile of both Jardiance and
Tradjenta.
"Across the lifespan, we know that people living with type 2
diabetes have a high risk for many diabetes complications, so it's
important to recognize and treat diabetes early in its course,"
said Lori Laffel, M.D., principal
investigator of the DINAMO study and chief of the Pediatric,
Adolescent, and Young Adult Section at the Joslin Diabetes Center
and professor of pediatrics at Harvard Medical
School. "Today's results from the DINAMO global clinical
trial demonstrated that the SGLT2 inhibitor Jardiance compared with
placebo significantly improved overall blood sugar control in
children and adolescents with type 2 diabetes. These findings are
particularly important given the need for more therapeutic options,
especially oral agents, to manage type 2 diabetes in young people
as, to date, metformin is the only globally available oral
treatment for youth."
A secondary endpoint from the trial showed that at week 26,
Jardiance reduced fasting plasma glucose (–35.2 mg/dL;
P=0.0035).
"With more than 41,000 new cases worldwide annually, type 2
diabetes in today's young people is a global public health issue,
especially in light of the rise of risk factors such as obesity,"
said Lykke Hinsch Gylvin, M.D., chief medical officer at Boehringer
Ingelheim. "The clinically meaningful benefit and consistent safety
profile demonstrated with Jardiance in the DINAMO trial is an
encouraging outcome for the vulnerable population of children and
adolescents."
"The rise in the prevalence of type 2 diabetes in the pediatric
population highlights a clear unmet need," said Jeff Emmick, M.D., Ph.D., vice president,
Product Development, Eli Lilly & Company. "Having overcome the
challenges in recruitment and design that pediatric trials tend to
face, the outcomes of DINAMO represent another positive step
forward in Boehringer Ingelheim and Lilly's commitment to improve
the lives of people living with cardio-renal and metabolic
conditions such as type 2 diabetes."
Reduction in HbA1c in participants treated with Tradjenta was
not statistically significant when compared with placebo. A
numerical reduction of 0.34% (P=0.2935) was observed.
The findings have been submitted for publication in a
peer-reviewed journal.
About DINAMO: DIabetes study of
liNAgliptin and eMpagliflozin in children and adOlescents
DINAMO (NCT03429543) enrolled children and adolescents aged
10-17 years with type 2 diabetes (HbA1c ≥6.5% and ≤10.5%). Of the
262 participants screened, 158 were randomly assigned to treatment
with Jardiance (10 or 25 mg) (n=52), Tradjenta (5 mg) (n=53) or
placebo (n=53) once daily. All participants were treated with diet
and exercise plus metformin and/or insulin (or no background if
metformin intolerant). The trial compared efficacy and safety of a
Jardiance dosing regimen compared with placebo and Tradjenta
compared with placebo on durable glycemic control in youth with
type 2 diabetes.
What is JARDIANCE?
JARDIANCE is a prescription medicine used to:
- reduce the risk of cardiovascular death and hospitalization for
heart failure in adults with heart failure, when the heart cannot
pump enough blood to the rest of your body
- reduce the risk of cardiovascular death in adults with type 2
diabetes who also have known cardiovascular disease
- lower blood sugar along with diet and exercise in adults with
type 2 diabetes
JARDIANCE is not for people with type 1
diabetes. It may increase their risk of diabetic
ketoacidosis (increased ketones in the blood or
urine).
JARDIANCE is not for use to lower blood sugar in adults with
type 2 diabetes who have severe kidney problems, because it may not
work.
IMPORTANT SAFETY INFORMATION
Do
not take JARDIANCE if you are allergic to
empagliflozin or any of the ingredients in
JARDIANCE.
Do not take JARDIANCE if you are
on dialysis.
JARDIANCE can cause serious side effects, including:
- Ketoacidosis (increased ketones in your blood or urine).
Ketoacidosis is a serious condition which needs to be treated in
the hospital. Ketoacidosis may lead to death. Ketoacidosis occurs
in people with type 1 diabetes and can also occur in people with
type 2 diabetes taking JARDIANCE, even if blood sugar is less
than 250 mg/dL. Ketoacidosis has also happened in people with
diabetes who were sick or who had surgery during treatment with
JARDIANCE. Stop taking JARDIANCE and call your healthcare
provider right away or go to the nearest hospital emergency room if
you get any of the following symptoms, and if possible, check
for ketones in your urine:
-
- nausea
- vomiting
- stomach-area (abdominal) pain
- tiredness
- trouble breathing
- Dehydration. JARDIANCE can cause some people to become
dehydrated (the loss of body water and salt). Dehydration may cause
you to feel dizzy, faint, light-headed, or weak, especially when
you stand up. Sudden worsening of kidney function has happened in
people who are taking JARDIANCE.
You may be at a
higher risk of dehydration if you:
-
-
- take medicines to lower your blood pressure, including water
pills (diuretics)
- are on a low salt diet
- have kidney problems
- are 65 years of age or older
Talk to your healthcare provider about what you
can do to prevent dehydration, including how much fluid you should
drink on a daily basis, and if you reduce the amount of food or
liquid you drink, if you are sick or cannot eat, or start to lose
liquids from your body from vomiting, diarrhea, or being in the sun
too long.
- Serious urinary tract infections. Serious urinary tract
infections can occur in people taking JARDIANCE and may lead to
hospitalization. Tell your healthcare provider if you have symptoms
of a urinary tract infection, such as a burning feeling when
passing urine, a need to urinate often or right away, pain in the
lower part of your stomach or pelvis, or blood in the urine.
Sometimes people also may have a fever, back pain, nausea or
vomiting.
- Low blood sugar (hypoglycemia): If you
take JARDIANCE with another medicine that can cause low blood
sugar, such as sulfonylurea or insulin, your risk of low blood
sugar is higher. The dose of your sulfonylurea or insulin may need
to be lowered. Symptoms of low blood sugar may include:
-
-
- headache
- drowsiness
- weakness
- dizziness
- confusion
- irritability
- hunger
- fast heartbeat
- sweating
- shaking or feeling jittery
- Necrotizing fasciitis. A rare but serious bacterial
infection that causes damage to the tissue under the skin in the
area between and around your anus and genitals (perineum). This
bacterial infection has happened in women and men who take
JARDIANCE, and may lead to hospitalization, multiple surgeries, and
death. Seek medical attention immediately if you have a fever or
are feeling very weak, tired or uncomfortable (malaise), and you
develop any of the following symptoms in the area between and
around your anus and genitals: pain or tenderness, swelling, and
redness of skin (erythema).
- Vaginal yeast infection. Talk to your healthcare
provider if you have vaginal odor, white or yellowish vaginal
discharge (discharge may be lumpy or look like cottage cheese),
and/or vaginal itching.
- Yeast infection of the penis. Swelling of an
uncircumcised penis may develop that makes it difficult to pull
back the skin around the tip of the penis. Talk to your healthcare
provider if you have redness, itching or swelling of the penis,
rash of the penis, foul smelling discharge from the penis, and/or
pain in the skin around the penis.
Talk to your healthcare provider about what to do if you get
symptoms of a yeast infection of the vagina or penis. Your
healthcare provider may suggest you use an over-the-counter
antifungal medicine. Talk to your healthcare provider right away if
you use an over-the-counter antifungal medication and your symptoms
do not go away.
- Allergic (hypersensitivity) reactions. Symptoms of
serious allergic reactions to JARDIANCE may include:
-
- swelling of your face, lips, throat, and other areas of your
skin
- difficulty with swallowing or breathing
- raised, red areas on your skin (hives)
If you have any of these
symptoms, stop taking JARDIANCE and contact your healthcare
provider or go to the
nearest emergency room right away.
The most common side effects of JARDIANCE include urinary tract infections and yeast infections in
females.
These are not all the possible side effects of JARDIANCE. For more information, ask your healthcare
provider or pharmacist.
Before taking JARDIANCE, tell your healthcare
provider about all of your medical conditions, including
if you:
- have kidney problems
- have liver problems
- have a history of infection of the vagina or penis
- have a history of urinary tract infections or problems with
urination
- are going to have surgery. Your healthcare provider may stop
JARDIANCE before you have surgery. Talk to your healthcare provider
about when to stop taking JARDIANCE if you are having surgery and
when to start it again
- are eating less or there is a change in your diet
- have or have had problems with your pancreas, including
pancreatitis or surgery on your pancreas
- drink alcohol very often, or drink a lot of alcohol in the
short term ("binge" drinking)
- have type 1 diabetes. JARDIANCE should not be used to treat
people with type 1 diabetes
- are pregnant or plan to become pregnant. JARDIANCE may harm
your unborn baby. Tell your healthcare provider right away if you
become pregnant during treatment with JARDIANCE
- are breastfeeding or are planning to breastfeed. JARDIANCE may
pass into your breast milk and may harm your baby. Do not
breastfeed while taking JARDIANCE
Tell your healthcare
provider about all the medicines you take,
including prescription and over-the-counter medicines,
vitamins, and herbal supplements.
You are
encouraged to report negative side
effects of prescription drugs
to the FDA. Visit
www.fda.gov/medwatch or call 1-800-FDA-1088.
For more information, please see Prescribing Information and
Medication Guide.
CL-JAR-100131 10.17.2022
Boehringer Ingelheim and Eli Lilly and Company
In
January 2011, Boehringer Ingelheim
and Eli Lilly and Company announced an Alliance that centers on
compounds representing several of the largest diabetes treatment
classes. Depending on geographies, the companies either co-promote
or separately promote the respective molecules each contributing to
the Alliance. The Alliance leverages the strengths of two of the
world's leading pharmaceutical companies to focus on patient needs.
By joining forces, the companies demonstrate their commitment, not
only to the care of people with diabetes, but also to investigating
the potential to address areas of unmet medical need.
About Boehringer Ingelheim
Boehringer Ingelheim is working on breakthrough therapies that
improve the lives of humans and animals. As a leading
research-driven biopharmaceutical company, the company creates
value through innovation in areas of high unmet medical need.
Founded in 1885 and family-owned ever since, Boehringer Ingelheim
takes a long-term perspective. Around 52,000 employees serve more
than 130 markets in the three business areas, Human Pharma, Animal
Health, and Biopharmaceutical Contract Manufacturing. Learn more
at www.boehringer-ingelheim.us.
About Eli Lilly and Company
Lilly unites caring with
discovery to create medicines that make life better for people
around the world. We've been pioneering life-changing discoveries
for nearly 150 years, and today our medicines help more than 47
million people across the globe. Harnessing the power of
biotechnology, chemistry and genetic medicine, our scientists are
urgently advancing new discoveries to solve some of the world's
most significant health challenges, redefining diabetes care,
treating obesity and curtailing its most devastating long-term
effects, advancing the fight against Alzheimer's disease, providing
solutions to some of the most debilitating immune system disorders,
and transforming the most difficult-to-treat cancers into
manageable diseases. With each step toward a healthier world, we're
motivated by one thing: making life better for millions more
people. That includes delivering innovative clinical trials that
reflect the diversity of our world and working to ensure our
medicines are accessible and affordable. To learn more, visit
Lilly.com and Lilly.com/newsroom or follow us on
Facebook, Instagram and LinkedIn.
This press release contains forward-looking statements (as
that term is defined in the Private Securities Litigation Reform
Act of 1995) about Jardiance® as a treatment for adults
with type 2 diabetes, to reduce the risk of cardiovascular death in
adults with type 2 diabetes and known cardiovascular disease, and
to reduce the risk of cardiovascular death and hospitalization for
heart failure in adults with heart failure, and as a potential
treatment for adults with cardio-kidney-metabolic conditions and
reflects Lilly's current beliefs and expectations. However, as with
any pharmaceutical product, there are substantial risks and
uncertainties in the process of drug research, development and
commercialization. Among other things, there can be no guarantee
that planned or ongoing studies will be completed as planned, that
future study results will be consistent with the results to date or
that Jardiance® will receive additional regulatory
approvals. For a further discussion of these and other risks and
uncertainties that could cause actual results to differ from
Lilly's expectations, please see Lilly's most recent Forms 10-K and
10-Q filed with the U.S. Securities and Exchange Commission. Lilly
undertakes no duty to update forward-looking statements.
Jardiance®, EMPEROR-Reduced®,
EMPEROR-Preserved®, EMPA-REG
OUTCOME® and EMPACT-MI® are
registered trademarks of Boehringer Ingelheim.
P-LLY
MPR-US-102413
CONTACTS:
Jennifer Forsyth
Boehringer Ingelheim
Email: jennifer.forsyth@boehringer-ingelheim.com
Phone: (203) 791-5889
Kristiane Bello
Eli Lilly and Company
Email: bello_kristiane@lilly.com
Phone: (317) 315-9052
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SOURCE Eli Lilly and Company