PARIS, July 29, 2015 /PRNewswire/ -- Sanofi
announced today that the LixiLan-O Phase III clinical trial met its
primary objective in patients with type 2 diabetes treated with
metformin. The fixed-ratio combination of insulin glargine 100
units/mL and lixisenatide, a GLP-1 RA, demonstrated statistically
superior reduction in HbA1c (average blood glucose over the
previous three months) compared with lixisenatide and compared with
insulin glargine 100 units/mL. Overall, the fixed-ratio combination
had a safety profile reflecting those of lixisenatide and insulin
glargine 100 units/mL.
"Meeting the primary objective of this important Phase III
study highlights the potential clinical value of this
investigational therapeutic option," said Dr. Elias Zerhouni, President, Global R&D at
Sanofi. "We look forward to advancing the LixiLan program and
bringing this combination of insulin glargine and lixisenatide to
patients."
The Phase III LixiLan clinical development program began in Q1
2014 and consists of the LixiLan-O and LixiLan-L trials. LixiLan-O
investigated the efficacy and safety of a once-daily single
injection of the fixed-ratio combination of insulin glargine 100
units/mL and lixisenatide versus treatment with either lixisenatide
or insulin glargine 100 units/mL over a 30 week period in 1,170
patients whose type 2 diabetes was not adequately controlled on
metformin alone or on metformin combined with a second oral
anti-diabetic agent. Treatment with metformin was continued for all
participants throughout the study. Full results will be
communicated in an appropriate scientific forum.
The ongoing LixiLan-L study investigates the efficacy and safety
of a once-daily single injection of the fixed-ratio combination of
insulin glargine 100 units/mL and lixisenatide versus treatment
with insulin glargine 100 units/mL over a 30-week period in 736
patients whose type 2 diabetes was not adequately controlled at
screening on a basal insulin with or without oral anti-diabetic
drugs. Only metformin, if taken, was continued throughout the
study. The study will be completed in Q3 2015.
Following an analysis of results from both Phase III studies,
LixiLan-O and LixiLan-L, Sanofi will determine the next steps in
the regulatory process. Currently, regulatory submissions are
planned for Q4 2015 in the United
States and Q1 2016 in the European Union.
What is Lantus® (insulin glargine injection) 100
Units/mL?
Prescription Lantus is a long-acting insulin used to treat
adults with type 2 diabetes and adults and pediatric patients
(children 6 years and older) with type 1 diabetes for the control
of high blood sugar.
- Do not use Lantus to treat diabetic ketoacidosis.
Important Safety Information For Lantus (insulin glargine
injection) 100 Units/mL
Do not take Lantus during episodes of low blood sugar or if you
are allergic to insulin or any of the inactive ingredients in
Lantus.
Do not share needles, insulin pens, or syringes with others.
Do NOT reuse needles.
Before starting Lantus, 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
already have heart failure, it may get worse while you take TZDs
with Lantus. Your treatment with TZDs and Lantus® 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:
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- Swelling of your ankles or feet
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Tell your doctor about all the medications you take, including
OTC medicines, vitamins, and supplements, including herbal
supplements.
Lantus should be taken once a day at the same time every
day. Test your blood sugar levels while using insulin, such
as Lantus. Do not make any changes to your dose or type of insulin
without talking to your healthcare provider. Any change of insulin
should be made cautiously and only under medical supervision.
Do NOT dilute or mix Lantus with any other insulin or
solution. It will not work as intended and you may lose blood
sugar control, which could be serious. Lantus must only be used if
the solution is clear and colorless with no particles visible.
Always make sure you have the correct insulin before each
injection.
While using Lantus, do not drive or operate heavy machinery
until you know how Lantus® affects you. You should not drink
alcohol or use other medicines that contain alcohol.
The most common side effect of insulin, including Lantus, is
low blood sugar (hypoglycemia), which may be serious and life
threatening. It may cause harm to your heart or
brain. Symptoms of serious low blood sugar may include
shaking, sweating, fast heartbeat, and blurred vision.
Lantus may cause serious side effects that can lead to death,
such as severe allergic reactions. Get medical help right
away if you have:
- A rash over your whole body
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- Swelling of your face, tongue, or throat
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- Extreme drowsiness, dizziness, or
confusion
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Other possible side effects may include swelling, weight gain,
low potassium levels, injection site reactions, including changes
in fat tissue at the injection site, and allergic reactions.
Please see accompanying full prescribing information for
Lantus or visit www.Lantus.com.
About Lixisenatide
Lixisenatide is a once-daily
prandial glucagon-like peptide-1 receptor agonist (GLP-1 RA) for
the treatment of adult patients with type 2 diabetes mellitus.
GLP-1 is a naturally-occurring peptide hormone that is released
within minutes after eating a meal. It is known to suppress
glucagon secretion from pancreatic alpha cells and stimulate
glucose-dependent insulin secretion by pancreatic beta cells.
Lixisenatide was in-licensed from Zealand Pharma A/S (NASDAQ OMX
Copenhagen: ZEAL), www.zealandpharma.com, and was approved in
Europe in 2013 for the treatment
of adults with type 2 diabetes mellitus to achieve glycemic control
in combination with oral glucose-lowering medicinal products and/or
basal insulin when these, together with diet and exercise, do not
provide adequate glycemic control. Lixisenatide is currently
approved in over 50 countries worldwide for the treatment of adults
with type 2 diabetes, with commercial launches in most EU
countries, Japan, Brazil, Mexico and other markets. Lixisenatide is an
investigational product in the U.S. It will be resubmitted to the
Food & Drug Administration (FDA) in the third quarter of
2015.
About Sanofi Diabetes
Sanofi strives to help people
manage the complex challenge of diabetes by delivering innovative,
integrated and personalized solutions. Driven by valuable insights
that come from listening to and engaging with people living with
diabetes, the Company is forming partnerships to offer diagnostics,
therapies, services, and devices including blood glucose monitoring
systems. Sanofi markets injectable, inhaled and oral medications
for people with type 1 or type 2 diabetes.
About Sanofi
Sanofi, a global healthcare leader,
discovers, develops and distributes therapeutic solutions focused
on patients' needs. Sanofi has core strengths in diabetes
solutions, human vaccines, innovative drugs, consumer healthcare,
emerging markets, animal health and Genzyme. Sanofi is listed in
Paris (EURONEXT: SAN) and in
New York (NYSE: SNY).
Sanofi Forward-Looking Statements
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release contains forward-looking statements as defined in the
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Forward-looking statements are statements that are not historical
facts. These statements include projections and estimates and their
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Forward-looking statements are generally identified by the words
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generally beyond the control of Sanofi, that could cause actual
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in, or implied or projected by, the forward-looking information and
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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
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the Group's ability to benefit from external growth opportunities,
trends in exchange rates and prevailing interest rates, the impact
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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
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applicable law, Sanofi does not undertake any obligation to update
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SOURCE Sanofi