Sanofi Announces Positive Phase 3 Results for Investigational Titratable Fixed-Ratio Combination of Insulin Glargine and Lixisenatide
(Thomson Reuters ONE) -
Sanofi Announces Positive Phase 3 Results for Investigational Titratable Fixed-
Ratio Combination of Insulin Glargine and Lixisenatide
- Both pivotal studies demonstrated superior reduction in HbA1c versus insulin
glargine and versus lixisenatide -
Paris, France - June 12, 2016 - Sanofi announced today the presentation of the
results of the pivotal Phase 3 LixiLan-O and LixiLan-L clinical trials with the
investigational titratable fixed-ratio combination of basal insulin glargine
100 Units/mL and GLP-1 receptor agonist lixisenatide in adults with type 2
diabetes. Both studies met their primary endpoints, demonstrating statistically
superior reduction of HbA1c (average blood glucose over the previous three
months) with the titratable fixed-ratio combination versus comparators
(lixisenatide and insulin glargine 100 Units/mL, respectively).The most frequent
adverse events were nausea, vomiting and diarrhea.
Full results were presented on June 12 at the American Diabetes Association
76(th) Scientific Sessions in New Orleans, LA, U.S. Top-line results were
previously reported in Q3 of 2015.
"These studies reflect Sanofi's commitment to innovative approaches in
developing medicines intended to help patients meet their needs throughout their
diabetes journey," said Jorge Insuasty MD, Senior Vice President, Global Head of
Development, Sanofi. "We look forward to continuing to work with the FDA and EMA
as they complete their reviews and to receiving their decisions."
The results of the LixiLan-O and LixiLan-L studies have been included in
regulatory submissions to the U.S. Food and Drug Administration (FDA) and
European Medicines Agency (EMA), with regulatory decisions anticipated in August
2016 (FDA) and Q1 -2017 (EMA).
The presentation abstracts are titled:
* Clinical Impact of Titratable Fixed-Ratio Combination of Insulin
Glargine/Lixisenatide vs. Each Component Alone in Type 2 Diabetes
Inadequately Controlled on Oral Agents: LixiLan-O Trial (NCT02058147)
(Rosenstock, J et al. Oral presentation 186-O, American Diabetes Association
76(th) Scientific Sessions, New Orleans, LA, U.S. at 8:45am on June
12, 2016).
* Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed-Ratio
Combination vs. Insulin Glargine in Patients with T2DM: the LixiLan-L Trial
(NCT02058160) (Aroda, V et al. Oral presentation 238-O, American Diabetes
Association 76(th) Scientific Sessions, New Orleans, LA, U.S. at 2:30pm on
June 12, 2016).
The proprietary name for the titratable fixed-ratio combination is under
consideration. Its safety and efficacy have not been evaluated by any regulatory
authority.
Results of Analyses
LixiLan-O
LixiLan-O investigated the efficacy and safety of a once-daily single injection
of the titratable fixed-ratio combination of insulin glargine 100 Units/mL and
lixisenatide versus treatment with either lixisenatide or insulin glargine
100 Units/mL alone 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 while other oral agents were discontinued.
After 30 weeks, the titratable fixed-ratio combination showed significantly
greater reductions in HbA1c from baseline (8.1%) versus insulin glargine
100 Units/mL and lixisenatide (-1.6%, -1.3%, -0.9%, respectively; p<0.0001),
reaching mean HbA1c levels of 6.5%, 6.8%, 7.3%, respectively. More subjects
reached target HbA1c <7% with the titratable fixed-ratio combination (74%)
versus insulin glargine 100 Units/mL (59%) or lixisenatide (33%). Mean body
weight increased with insulin glargine 100 Units/mL (+1.1kg), and decreased with
the titratable fixed-ratio combination (-0.3kg; difference 1.4kg, p<0.0001) and
lixisenatide (-2.3kg).
Documented (<=70 mg/dL) symptomatic hypoglycemia was similar with the titratable
fixed-ratio combination (25.6% of patients; 1.44 events/year; E/Y) and insulin
glargine 100 Units/mL (23.6% of patients; 1.22 E/Y), but lower with lixisenatide
(6.4% of patients; 0.34 E/Y). With the titratable fixed-ratio combination, 9.6%
of participants experienced nausea and 3.2% experienced vomiting; with insulin
glargine 100 Units/mL, 3.6% of participants experienced nausea and 1.5%
experienced vomiting; and with lixisenatide 24.0% of participants experienced
nausea and 6.4% experienced vomiting.
LixiLan-L
LixiLan-L investigated the efficacy and safety of the titratable 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 basal insulin,
alone or combined with one to two oral anti-diabetic agents. Treatment with
metformin, if previously taken, was continued throughout the study while other
oral agents were discontinued.
After 30 weeks, the titratable fixed-ratio combination showed significantly
greater reductions in HbA1c from baseline (8.1%) versus insulin glargine
100 Units/mL (-1.1% versus -0.6%; p<0.0001), reaching mean HbA1c levels of 6.9%
and 7.5%, respectively. More subjects reached target HbA1c <7% with the
titratable fixed-ratio combination (55%) versus insulin glargine 100 Units/mL
(30%; p<0.0001). Mean body weight increased with insulin glargine 100 Units/mL
(+0.7 kg), and decreased with the titratable fixed-ratio combination (-0.7 kg;
difference 1.4 kg, p<0.0001).
Documented (<=70 mg/dL) symptomatic hypoglycemia was similar with the titratable
fixed-ratio combination (40% of patients; 3.0 events/year; E/Y) and insulin
glargine 100 Units/mL (42.5% of patients; 4.2 E/Y). With the titratable fixed-
ratio combination, 10.4% of participants experienced nausea, and 3.6%
experienced vomiting; while with insulin glargine 100 Units/mL 0.5% of
participants experienced nausea and 0.5% experienced vomiting.
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:
* 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, 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 * Swelling of your face, tongue, or throat
* Trouble breathing * Shortness of breath
* A fast heartbeat * Extreme drowsiness, dizziness, or
confusion
* Sweating
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 60 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.
About Sanofi Diabetes & Cardiovascular
Diabetes and cardiovascular disease affect millions of people worldwide, with
many managing the complex challenges of both. Building on our portfolio
evolution, heritage and expertise, Sanofi has a focused business unit dedicated
to delivering innovative, value-based medicines and integrated solutions in
these therapeutic areas. We are committed to a collaborative approach that
involves strategic alliances with professional and patient associations,
research institutions and leaders in healthcare and other industries, with the
goal of advancing scientific knowledge, driving the convergence of science and
technology, helping to improve outcomes and inspiring an evolution in care.
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
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statements regarding future performance. Forward-looking statements are
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management believes that the expectations reflected in such forward-looking
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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
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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 Investor Relations
Phil McNamara George Grofik
Tel.: +1-908-981-5497 Tel.: +33 (0)1 53 77 45 45
philip.mcnamara(at)sanofi.com ir(at)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(at)sanofi.com mai.tran(at)sanofi.com
Press release:
http://hugin.info/152918/R/2019613/749868.pdf
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Source: Sanofi via GlobeNewswire
[HUG#2019613]
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Datum: 12.06.2016 - 21:45 Uhr
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