BRIDGEWATER, N.J., Nov. 4, 2019 /PRNewswire/ -- Children and
adolescents (aged 6 to 17 years) living with type 1 diabetes
achieved comparable reduction in average blood sugar
(HbA1c) and similar risk of low blood sugar events with
Toujeo® (insulin glargine injection) 300 Units/mL
compared to insulin glargine 100 Units/mL (Gla-100), according to
results presented at the International Society for Pediatric and
Adolescent Diabetes 45th Annual Conference in
Boston,
Massachusetts.1
"We know that living with type
1 diabetes means dealing with highs and lows in blood sugar, which
are worrying and present substantial challenges for young
people," said Prof. Dr. Thomas
Danne, Director of the Department of General Pediatrics and
Endocrinology/Diabetology at the Children's Hospital On the Bult,
Hannover Medical School, Germany.
"In addition to the trial demonstrating safety and efficacy, the
percentage of patients with severe hypoglycemia, and the percentage
with hyperglycemia with ketosis, were numerically lower with
Toujeo."
The trial, EDITION JUNIOR, is the first randomized, controlled
trial comparing Toujeo vs Gla-100 in this group of patients. The
study met its primary endpoint with comparable reductions in
average blood sugar over 6 months with both treatments and similar
risk of low blood sugar events (hypoglycemia). The percentages of
patients who experienced severe hypoglycemia and who experienced
high blood sugar (hyperglycemia) with ketosis were numerically
lower with Toujeo. As these are serious short-term complications,
these findings are clinically important for people with type 1
diabetes.
"Across the globe, between 50
and 80 percent of young people living with type 1 diabetes need
more treatment options to help them achieve an average blood sugar
level below 7.5%," said Dietmar
Berger, Global Head of Development at Sanofi. "By taking
this step toward investigating an additional option for children
and adolescents living with diabetes, we hope to provide another
treatment for them and their physicians, to develop an
individualized treatment plan that helps patients better manage
their disease."
About the study
The EDITION JUNIOR study1 compared Toujeo to Gla-100
in 463 children and adolescents (aged 6 to 17 years) treated for
type 1 diabetes for at least one year and with HbA1c
between 7.5% and 11.0% at screening. Participants continued to use
their existing mealtime insulin.
The study met its primary endpoint, confirming non-inferior
reduction of HbA1c with Toujeo vs Gla-100 after 26 weeks
(mean reduction 0.4% vs 0.4%; difference: 0.004%, 95% CI
-0.17 to 0.18; upper bound was below the pre-specified
non-inferiority margin of 0.3%).
Over the same period, a comparable number of patients
experienced one or more anytime (24h) documented low blood sugar
(hypoglycemia) events. Numerically fewer patients using Toujeo
experienced severe hypoglycemia, or experienced one or more
episodes of high blood sugar (hyperglycemia) with ketosis compared,
with those using Gla-100.
The number of adverse events was comparable between the two
treatment groups (65.2% vs 65.8% of patients reported any
treatment-emergent adverse event). No unexpected safety concerns
were reported, based on the established profiles of both
products.
|
Toujeo
(n=233)
|
Gla-100
(n=228)
|
One or more event of
severe and/or
documented
(≤ 70 mg/dL) hypoglycemia (24 h)
|
226 (97%)
|
223
(97.8%)
|
RR:
0.99 95% CI: 0.96 to
1.02
|
One or more event of
severe and/or
documented
(< 54 mg/dL) hypoglycemia (24 h)
|
187
(80.3%)
|
191
(83.8%)
|
RR:
0.96 95% CI: 0.88 to
1.04
|
One or more episode
of severe
hypoglycemia (24 h)
|
14 (6.0%)
|
20 (8.8%)
|
RR:
0.68 95% CI (0.35 to
1.30)
|
One or more event of
hyperglycemia with
ketosis (ketones ≥1.5 mmol/L)
|
19 (8.2%)
|
26 (11.4%)
|
The study design includes a further 6-month safety follow-up
period, which will be reported separately.
The safety and efficacy of Toujeo in the adolescent population
is currently under regulatory review in the US. The safety and
efficacy for this use has not been fully evaluated.
What is Toujeo® (insulin glargine injection) 300
Units/mL?
Prescription Toujeo® is a
long-acting insulin used to control blood sugar in adults with
diabetes mellitus.
- Toujeo® contains 3 times as much insulin in 1
mL as standard insulin (100 Units/mL)
- Toujeo® is not for use to treat diabetic
ketoacidosis
- Toujeo® should not be used in children
Important Safety Information for Toujeo® (insulin
glargine injection) 300 Units/mL
Do not take
Toujeo® if you have low blood sugar or if you are
allergic to insulin or any of the ingredients in
Toujeo®.
Do not share your pen(s) with other people, even if the
needle has been changed. You may give other people a serious
infection, or get a serious infection from them.
Before starting Toujeo®, tell your doctor about all
your medical conditions, including if you have liver or kidney
problems, if you are pregnant or planning to become pregnant, or if
you are breastfeeding or planning to breastfeed.
Heart failure can occur if you are taking insulin together with
pills called TZDs (thiazolidinediones), even if you have never had
heart failure or other heart problems. If you have heart failure,
it may get worse while you take TZDs with
Toujeo®. Your treatment with TZDs and
Toujeo® may need to be changed or stopped by your
doctor if you have new or worsening heart failure. Tell your doctor
if you have any new or worsening symptoms including:
- Shortness of breath
- Sudden weight gain
- Swelling of your ankles or feet
Tell your doctor about all the medications you take, including
OTC medicines, vitamins, and supplements, and herbal
supplements.
Toujeo® should be taken at the same time once a day.
Test your blood sugar levels daily while using any insulin. Do not
change your dose or type of insulin without talking to your doctor.
Verify you have the correct insulin before each injection. Do
NOT use a syringe to remove Toujeo® from your
pen. Your dose for Toujeo® may be different
from other insulins you have taken. Any change of insulin should be
made cautiously and only under medical supervision.
Do NOT dilute or mix Toujeo® with any
other insulin or solution. It will not work as intended and you
may lose blood sugar control, which could be serious. Use
Toujeo® only if the solution is clear and colorless with
no particles visible.
While using Toujeo®, do not drive or operate
heavy machinery until you know how Toujeo®
affects you. Don't drink alcohol or use other medicines that
contain alcohol.
The most common side effect of any insulin, including
Toujeo®, is low blood sugar (hypoglycemia), which may be
serious and life-threatening. Severe hypoglycemia may cause
harm to your heart or brain. Symptoms of serious low blood sugar
may include shaking, sweating, fast heartbeat, and blurred
vision.
Toujeo® may cause severe allergic reactions
that can lead to death. Get medical help right away if you
have:
- A rash over your
whole body
- Shortness of
breath
- Swelling of your
face, tongue, or
throat
|
- Extreme drowsiness,
dizziness, or
confusion
- Trouble
breathing
- Fast
heartbeat
- Sweating
|
Toujeo® may have additional side effects
including swelling, weight gain, low potassium, and injection site
reactions which may include change in fat tissue, skin thickening,
redness, swelling, and itching.
Toujeo® SoloStar® and
Toujeo® Max SoloStar® are disposable
prefilled insulin pens. It is important to perform a safety test
when using a new pen for the first time. Talk to your doctor about
proper injection technique and follow instructions in the
Instruction Leaflet that comes with the pen.
Please see full Prescribing Information.
References
- Danne T et al., "Insulin Glargine 300 U/mL (Gla-300) provides
effective glycemic control in youths with type 1 diabetes (T1D):
the EDITION JUNIOR study", Poster presentation P240, ISPAD 45th
Annual Conference, Boston MA,
U.S., October 31, 2019. Available via
http://www.professionalabstracts.com/ispad2019/Iplanner/#/presentation/216 [Accessed
October 2019].
About Sanofi
Sanofi is dedicated to supporting people through their health
challenges. We are a global biopharmaceutical company focused on
human health. We prevent illness with vaccines, provide innovative
treatments to fight pain and ease suffering. We stand by the few
who suffer from rare diseases and the millions with long-term
chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is
transforming scientific innovation into healthcare solutions around
the globe.
Sanofi, Empowering Life
Media Relations
Contact
|
Investor Relations
Contact
|
Nicolas
Kressmann
|
George
Grofik
|
Tel.: +1 (732) 532
5318
|
Tel.: +33 (0)1 53 77
45 45
|
Nicolas.Kressmann@sanofi.com
|
ir@sanofi.com
|
Sanofi Forward-Looking Statements
This press release contains forward-looking statements as
defined in the Private Securities Litigation Reform Act of 1995, as
amended. Forward-looking statements are statements that are not
historical facts. These statements include projections and
estimates and their underlying assumptions, statements regarding
plans, objectives, intentions and expectations with respect to
future financial results, events, operations, services, product
development and potential, and statements regarding future
performance. Forward-looking statements are generally identified by
the words "expects", "anticipates", "believes", "intends",
"estimates", "plans" and similar expressions. Although Sanofi's
management believes that the expectations reflected in such
forward-looking statements are reasonable, investors are cautioned
that forward-looking information and statements are subject to
various risks and uncertainties, many of which are difficult to
predict and generally beyond the control of Sanofi, that could
cause actual results and developments to differ materially from
those expressed in, or implied or projected by, the forward-looking
information and statements. These risks and uncertainties include
among other things, the uncertainties inherent in research and
development, future clinical data and analysis, including post
marketing, decisions by regulatory authorities, such as the FDA or
the EMA, regarding whether and when to approve any drug, device or
biological application that may be filed for any such product
candidates as well as their decisions regarding labelling and other
matters that could affect the availability or commercial potential
of such product candidates, the absence of guarantee that the
product candidates if approved will be commercially successful, the
future approval and commercial success of therapeutic alternatives,
Sanofi's ability to benefit from external growth opportunities, to
complete related transactions and/or obtain regulatory clearances,
risks associated with intellectual property and any related pending
or future litigation and the ultimate outcome of such
litigation, trends in exchange rates and prevailing interest
rates, volatile economic conditions, the impact of cost containment
initiatives and subsequent changes thereto, the average number of
shares outstanding as well as those discussed or identified in the
public filings with the SEC and the AMF made by Sanofi, including
those listed under "Risk Factors" and "Cautionary Statement
Regarding Forward-Looking Statements" in Sanofi's annual report on
Form 20-F for the year ended December 31,
2018. Other than as required by applicable law, Sanofi does
not undertake any obligation to update or revise any
forward-looking information or statements.
Source: Sanofi (EURONEXT: SAN) (NASDAQ: SNY)
View original
content:http://www.prnewswire.com/news-releases/positive-results-in-phase-3-trial-for-toujeo-in-children-and-adolescents-with-type-1-diabetes-300950052.html
SOURCE Sanofi