Successful Switch to Sanofi's Toujeo® Evaluated in a Real-World Setting

Paris (ots/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-naïve 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
(http://en.sanofi.com/investors/share/stock_chart/stock_chart.aspx))
and in New York (NYSE: SNY
(http://en.sanofi.com/investors/share/stock_chart/stock_chart.aspx)).

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in the Private Securities Litigation Reform Act of 1995, as amended.
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among other things, the uncertainties inherent in research and
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Regarding Forward-Looking Statements" in Sanofi's annual report on
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required by applicable law, Sanofi does not undertake any obligation
to update or revise any forward-looking information or statements.

ots Originaltext: sanofi-aventis Group
Im Internet recherchierbar: http://www.presseportal.de

Contact:
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. Susan Brooks
Tel : 908-981-6566
susan.brooks@sanofi.com / Corporate Communications
Mai Tran
Tel.: +33 (0) 1.53.77.49.86
mai.tran@sanofi.com