PARIS, June 11, 2016 /CNW/ -
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) and in
New York (NYSE: SNY).
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SOURCE SANOFI