PARIS, June 12, 2016 /PRNewswire/ -- 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 76th
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
76th Scientific Sessions, New
Orleans, LA, U.S. at 8:45 a.m. 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 76th Scientific Sessions,
New Orleans, LA, U.S. at 2:30 p.m. 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:
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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 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).
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