PARIS, June 11, 2016 /PRNewswire/ -- Sanofi
announced today the release of the new real world data assessing
the use of Toujeo® (insulin glargine injection 300
Units/mL). The U.S. Predictive Health Intelligence Environment
(PHIE) database, containing a substantial amount of patient level
information, was analyzed to assess Toujeo in this real life
setting. The study examined electronic health records to assess the
change in HbA1c (average blood sugar levels) and
occurrence of hypoglycemia in patients up to 6 months after
switching to Toujeo from another basal insulin. The results of the
study were presented on June 11 at
the American Diabetes Association 76th Scientific
Sessions in New Orleans, LA,
U.S.A.
"In the first evaluation of Toujeo in the real-world care
setting, it is encouraging for the treatment of adults with type 2
diabetes to see the successful switching to Toujeo from another
basal insulin," said Riccardo
Perfetti, Head of Global Diabetes Medical Team, Sanofi.
"This study adds to the growing evidence in the knowledge of
the use of Toujeo, in patients with Type 2 diabetes," said
Professor Robert Ritzel, a Toujeo
clinical trials program investigator and Head Physician of the
Clinic for Endocrinology, Diabetes and Addiction Medicine,
Schwabing Hospital, Munich,
Germany. "While adequate and well-controlled clinical
trials are vital for regulatory requirements and guidance
of clinical decision making, further evidence in a
real-world care setting is particularly relevant for health-care
professionals, payers and other organizations when assessing safety
and efficacy in larger patient populations and
cost-effectiveness."
Sanofi is committed to evaluate Toujeo in the real life settings
and is conducting three large studies called ACHIEVE, REACH and
REGAIN CONTROL in type 2 diabetes patients starting basal insulin
treatment or switching from another basal insulin. These studies
involve more than 4,500 patients across the U.S. and Europe. Initial results of the Real-Life Study
Program are anticipated in 2017.
Results of Analysis
Adults with type 2 diabetes who had used other basal insulins
within the 6 months prior to Toujeo initiation (one or more
prescription order of Toujeo between March
2015 and December 2015) were
identified. The PHIE records of those identified (N=881) were
assessed for HbA1c and incidence of confirmed (≤70
mg/dL) or severe hypoglycemia up to 6 months prior to and up to 6
months after initiation.
Among the subpopulation of patients (n=267) with
HbA1c measured at baseline and during follow-up (0-6
months), mean HbA1c was 8.97% at baseline and 8.33% at
follow-up. For the subpopulation of patients (n=449) with
occurrence of hypoglycemia measured at baseline and during
follow-up (0-3 months), this was 6.0% at baseline and 5.1% at
follow-up.
The study abstract is titled: Real-World Assessment of
Patient Characteristics and Clinical Outcomes of Early Users of the
New Insulin Glargine 300U/mL (Ye, F et al. Poster presentation
943-P, American Diabetes Association 76th Scientific
Sessions, New Orleans, LA, U.S.
Saturday, June 11, 2016).
About ACHIEVE, REACH and REGAIN CONTROL
The ACHIEVE
CONTROL study will evaluate the effect of Toujeo® on
achieving individualized glycemic targets without hypoglycemia at
any time of day in 3,270 uncontrolled insulin-naive people in the
U.S. with type 2 diabetes.
The REACH CONTROL will follow 800 insulin-naïve people with type
2 diabetes in Europe, comparing
HbA1c change with Toujeo® vs. other basal insulins,
alongside incidence of hypoglycemia, change in body weight, and
measures of persistence with treatment and need for treatment
intensification.
The REGAIN CONTROL study will compare HbA1c reduction, incidence
of hypoglycemia, change in body weight and persistence with
treatment on Toujeo® vs. other basal insulins in 600
people with type 2 diabetes in Europe, who are currently uncontrolled on
basal insulin. In addition to clinical measures, the studies will
also collect patient feedback on treatment satisfaction and their
experience of hypoglycemia, along with healthcare resource
utilization.
About Toujeo®
Toujeo is a once-daily basal
insulin based on a broadly-used molecule (insulin glargine). Toujeo
has been approved by the U.S. Food and Drug Administration (FDA),
the European Commission, Health Canada, the Therapeutic Goods
Administration in Australia, and
the MHLW in Japan (where its
approved brand name is Lantus® XR), and is under review by other
regulatory authorities around the world.
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® during episodes of low blood
sugar or if you are allergic to insulin or any of the ingredients
in Toujeo®.
Do NOT reuse needles or share insulin pens even if the needle
has been changed.
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 breast-feeding or planning to breast-feed
Heart failure can occur if you are taking insulin together with
certain medicines 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 of heart failure, including:
- Shortness of breath
- Swelling of your ankles or feet
- Sudden weight gain
Tell your doctor about all the medications you take, including
OTC medicines, vitamins, and supplements, including herbal
supplements.
Toujeo should be taken at the same time once a day. Test your
blood sugar levels daily while using any insulin, including
Toujeo®. Do not make changes to your dose or type of
insulin without talking to your doctor. Verify you have the correct
insulin before each injection. 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. You
should not drink alcohol or use other medicines that contain
alcohol.
The most common side effects of any insulin, including
Toujeo®, is low blood sugar (hypoglycemia), which may be
serious and can be 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 serious side effects that can lead
to death, such as severe allergic reactions that affect the whole
body. Get medical help right away if you have:
- A rash over your whole body
- Trouble breathing
- Shortness of breath
- Fast heartbeat
- Swelling of your face, tongue, or throat
- Sweating
- Extreme drowsiness, dizziness, or confusion
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.
Please see full Prescribing Information for Toujeo® on
Toujeo.com or click here
http://products.sanofi.us/Toujeo/Toujeo.pdf
About Sanofi
Sanofi, a global healthcare leader,
discovers, develops and distributes therapeutic solutions focused
on patients' needs. Sanofi is organized into five global business
units: Diabetes and Cardiovascular, General Medicines and Emerging
Markets, Sanofi Genzyme, Sanofi Pasteur and Merial. Sanofi is
listed in Paris (EURONEXT: SAN)
and in New York (NYSE: SNY).
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,
the Group's ability to benefit from external growth opportunities,
trends in exchange rates and prevailing interest rates, 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, 2015. Other than as required by
applicable law, Sanofi does not undertake any obligation to update
or revise any forward-looking information or statements.
Contacts:
Global Diabetes
Communications
Serge
Spierckel
Tel.: +33 (0) 6 75 71
61 24
serge.spierckel@sanofi.com
|
Investor
Relations
George
Grofik
Tel.: +33 (0)1 53 77
45 45
ir@sanofi.com
|
US Diabetes
Communications
|
Corporate
Communications
|
Susan
Brooks
|
Mai Tran
|
Tel :
908-981-6566
|
Tel.: +33 (0)
1.53.77.49.86
|
susan.brooks@sanofi.com
|
mai.tran@sanofi.com
|
US.GLT.16.06.026
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/successful-switch-to-sanofis-toujeo-evaluated-in-a-real-world-setting-300283351.html
SOURCE Sanofi