ORLANDO, Fla., June 25, 2018 /PRNewswire/ -- Sanofi
(NYSE: SNY; EURONEXT: SAN) presented positive non-inferiority
results of the BRIGHT study comparing its long-acting insulin
Toujeo® to insulin degludec at the American Diabetes
Association (ADA) 78th Scientific Sessions in
Orlando, Florida.1
At the end of the BRIGHT study, Toujeo demonstrated comparable
blood sugar (HbA1c) control versus insulin degludec
(-1.64% vs. -1.59%, respectively). During the first 12 weeks of
therapy, a period when patients and physicians work to determine
the most appropriate individual insulin dose, Toujeo reduced the
rate of low blood sugar (hypoglycemia) events by 23 percent and the
incidence of low blood sugar events by 26 percent, compared to
insulin degludec (p<0.05).2 During the subsequent 12
weeks of the study (treatment period: 13-24 weeks), the two
treatments showed comparable incidence and rate of low blood sugar
events.
"Hypoglycemia is a concern for
people with diabetes, particularly in the initial period of dose
adjustment," says Alice Cheng,
Associate Professor of Endocrinology, University of Toronto, Toronto, Canada, and a primary investigator of
the study. "Experiencing hypoglycemia, particularly in this
early treatment period, could lead to patients discontinuing their
treatment."
The incidence of low blood sugar at any time of the day during
the 24-week treatment period was also comparable between Toujeo and
insulin degludec (66.5% and 69.0%, respectively).
Results of the BRIGHT study:
The randomized controlled trial compared the efficacy and safety
of Toujeo versus insulin degludec at 24 weeks. The study randomized
929 adults with type 2 diabetes to once-daily Toujeo or insulin
degludec 100 Units/mL. Before randomization, participants were
inadequately controlled with tablets (oral anti-hyperglycemic
drugs, OADs), with or without a glucagon-like peptide-1 (GLP-1)
receptor agonist, and had not previously started insulin
therapy.1
The study met its primary endpoint demonstrating a reduction in
blood sugar (HbA1c) levels comparable with Toujeo and
insulin degludec from baseline to week 24 (at a non-inferiority
margin of 0.3% and difference between treatments of -0.05% [95% CI
−0.15 to 0.05%]).1
Over the 24-week period, incidence and event rates of confirmed
(≤70 mg/dL and ≤54 mg/dL) low blood sugar (hypoglycemia) at any
time of day were comparable between Toujeo and insulin degludec.
During the titration period (0-12 weeks), confirmed low blood sugar
event rates were lower by 23 percent (≤70 mg/dL) and 43 percent
(≤54 mg/dL). In this period, the incidence of confirmed low blood
sugar was also reduced by 26 percent (≤70 mg/dL) and 37 percent
(≤54 mg/dL). Low blood sugar incidence and event rates were
comparable in the maintenance time period (13-24
weeks).2
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 pens.
Please see full Prescribing Information.
References
1.
|
Cheng A, et al.
Similar Glycemic Control and Less or Comparable Hypoglycemia with
Insulin Glargine 300 U/mL (Gla-300) vs Degludec 100 U/mL (IDeg-100)
in Insulin-Naïve T2DM on Antihyperglycemic Drugs ± GLP-1 RAs: The
BRIGHT Randomized Study. Presentation 301-OR, American Diabetes
Association (ADA) 78th annual congress in Orlando, Florida, U.S.,
June 25, 2018
|
2.
|
Bolli GB, et al.
Lower Hypoglycemia Rates with Insulin Glargine 300 U/mL (Gla-300)
vs Insulin Degludec 100 U/mL (IDeg-100) in Insulin-Naïve Adults
with T2DM on Oral Antihyperglycemic Therapy ± GLP-1 RA: The BRIGHT
Randomized Study. Presentation 1032-P, American Diabetes
Association (ADA) 78th annual congress in Orlando, Florida, U.S.,
June 23, 2018
|
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
US Media
Relations Ashleigh Koss
Tel. : +1 (908) 981-8745
Mobile: +1 (908) 205-2572
Ashleigh.Koss@sanofi.com
|
Investor Relations
Contact George Grofik
Tel.: +33 (0)1 53 77 45 45
ir@sanofi.com
|
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