SAN DIEGO, June 10, 2017 /PRNewswire/ -- Sanofi
announced today that Soliqua® 100/33 (insulin glargine
& lixisenatide injection) 100 Units/mL & 33 mcg/mL lowered
mean blood sugar levels (HbA1c) by between 1.09 and 2.41
percent after 30 weeks in adults with type 2 diabetes previously
treated with between 15 and 40 units of basal insulin daily. This
new post-hoc analysis of data from the LixiLan-L Phase 3 study,
which grouped participants by HbA1c level at screening,
also showed that all subgroups reached a mean HbA1c
below 7 percent during the study period.
"Lowering elevated HbA1c is an important treatment
goal in people with diabetes," said Riccardo Perfetti, Vice President, Head of
Global Medical Affairs Diabetes, Sanofi. "This analysis
demonstrated the substantial blood sugar lowering effect that can
be achieved with Soliqua 100/33, and also its potential to help
adults reach HbA1c levels below 7 percent, which is
recommended as a treatment goal by bodies such as the American
Diabetes Association for many adults with
diabetes."1
Soliqua® 100/33, which is used in conjunction with
diet and exercise, is marketed as Suliqua® in the
EU.
The abstract is titled "iGlarLixi Reduces A1C to a Greater
Extent Than Basal Insulin Therapy Regardless of A1C Levels at
Screening" (Niemoeller E et al. Poster presentation 1079-P,
American Diabetes Association (ADA) 77th Scientific
Sessions, San Diego, CA, U.S.,
June 10).
Summary of analysis
This post-hoc analysis reviewed
data from the LixiLan-L pivotal Phase 3 trial, which compared the
effectiveness of Soliqua 100/33 and insulin glargine 100 Units/mL
in 736 adults whose type 2 diabetes was not adequately controlled
at screening on between 15 and 40 units of basal insulin daily,
alone or combined with one or two oral anti-diabetic agents. The
primary outcome of the LixiLan-L study, a statistically significant
reduction in HbA1c compared with insulin glargine 100
Units/mL, was previously reported.2
The analysis evaluated data for the 660 participants who
completed the 30 week study period. Patients were split in three
categories based on HbA1c at screening: HbA1c
≤8%, HbA1c >8% to ≤9%, and HbA1c >9%.
Change from screening to study end was determined with ANOVA
analysis of 30-week completers in the modified intention-to-treat
(mITT) population. Least Squares (LS) mean reductions in
HbA1c for the Soliqua 100/33 treatment groups after 30
weeks were 1.09%, 1.44% and 2.41%, respectively. The mean
HbA1c observed for each subgroup was ≤7% with Soliqua
100/33 (6.65%, 6.99% and 6.97% respectively), but >7% with
insulin glargine 100 Units/mL alone (7.22%, 7.42% and 7.66%,
respectively). Reductions in HbA1c were greater for
Soliqua 100/33 in all defined categories versus insulin glargine
100 Units/mL (p<0.0001 for all comparisons).
As previously reported for LixiLan-L,2 incidence of
documented (≤70 mg/dL / 3.9 mmol/L) symptomatic hypoglycemia was
similar with Soliqua 100/33 (40% of patients; 3.0 events/year; E/Y)
and insulin glargine 100 Units/mL (42.5% of patients; 4.2 E/Y).
With Soliqua 100/33, 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 SOLIQUA® 100/33 (insulin glargine
and lixisenatide injection) 100 Units/mL and 33 mcg/mL?
SOLIQUA 100/33 is an injectable prescription medicine that
contains 2 diabetes medicines, insulin glargine and lixisenatide,
that may improve blood sugar (glucose) control in adults with type
2 diabetes, when used with diet and exercise in people who are not
controlled with long-acting (basal) insulin (less than 60 units
daily) or lixisenatide.
- It has not been studied in people with a history of
pancreatitis.
- It is not recommended for people who also take lixisenatide or
other medicines called GLP-1 receptor agonists.
- It is not for use in people with type 1diabetes, diabetic
ketoacidosis, or who have a stomach problem that causes slow
emptying (gastroparesis).
- It has not been studied together with short-acting
insulin.
- It is not known if SOLIQUA 100/33 is safe and effective in
children under 18 years of age.
Important Safety Information for SOLIQUA®
100/33 (insulin glargine and lixisenatide injection) 100
Units/mL and 33 mcg/mL
What is the most important information I should know about
SOLIQUA 100/33?
Do not share your SOLIQUA 100/33 pen with other people, even
if the needle has been changed.
SOLIQUA 100/33 can cause serious side effects, including
inflammation of the pancreas, which may be
life-threatening.
Before using SOLIQUA 100/33, tell your doctor if you have
had:
- pancreatitis
- stones in your gallbladder (cholelithiasis)
- a history of alcoholism
These medical problems may make you more likely to get
pancreatitis. Stop taking SOLIQUA 100/33 and call your healthcare
provider right away if you have pain in your stomach area (abdomen)
that is severe, and will not go away. The pain may be felt in the
back area. The pain may happen with or without vomiting.
Who should not use SOLIQUA 100/33?
Do not use SOLIQUA 100/33 if you are having an episode of low
blood sugar (hypoglycemia) or if you are allergic to insulin
glargine, lixisenatide, or any of the other ingredients in SOLIQUA
100/33.
Tell your healthcare provider about all your medical
conditions, including if you:
- have or have had symptoms of acute pancreatitis, stones in your
gallbladder, or a history of alcoholism.
- have or have had liver or kidney problems.
- have heart failure or other heart problems. If you have heart
failure, it may get worse while you take TZDs
(thiazolidinediones).
- have severe problems with your stomach, such as slowed emptying
of your stomach or problems digesting food.
- are pregnant or plan to become pregnant. It is not known if
SOLIQUA 100/33 will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if
SOLIQUA 100/33 passes into your breast milk.
Tell your healthcare provider about all the medicines you
take, including all prescription and over-the-counter
medicines, vitamins, and herbal supplements. SOLIQUA 100/33 may
affect the way some medicines work.
How should I use SOLIQUA 100/33?
- Do not change your dose unless your healthcare provider has
told you to change your dose.
- Check the pen label each time you inject to make sure you are
using the correct medicine.
- Do not take more than 60 units of SOLIQUA 100/33 each
day. If you take too much, it can cause severe nausea and
vomiting. Do not take SOLIQUA 100/33 with other GLP-1 receptor
agonists. If you take too much SOLIQUA 100/33, call your healthcare
provider or go to the nearest hospital emergency room right
away.
- Only use SOLIQUA 100/33 that is clear, colorless to almost
colorless. If you see small particles, return it to your pharmacy
for replacement.
- Do not mix SOLIQUA 100/33 in any other type of insulin
or liquid medicine prior to injection.
- Do not remove SOLIQUA 100/33 from the pen with a
syringe.
- Do not re-use or share needles with other people. You may
give other people a serious infection, or get a serious infection
from them.
- Check your blood sugar levels. Ask your healthcare
provider what your blood sugar should be and when you should
check.
SOLIQUA 100/33 may cause serious side effects,
including:
- Serious allergic reactions. Severe allergic reactions
can happen with SOLIQUA 100/33. Stop taking it and get help right
away if you have any symptoms which may include swelling of your
face, lips, tongue, or throat, problems breathing or swallowing,
severe rash or itching, fainting or feeling dizzy and very rapid
heartbeat.
- Low blood sugar (hypoglycemia). Your risk for getting low
blood sugar is higher if you take another medicine that can cause
low blood sugar. Signs and symptoms of low blood sugar may
include:
-
- headache
- weakness
- fast heartbeat
- dizziness
- irritability
- feeling jittery
- drowsiness
- hunger
- confusion
- sweating
- Kidney problems (kidney failure). In people who have
kidney problems, diarrhea, nausea, and vomiting may cause a loss of
fluids (dehydration) which may worsen kidney problems.
- Low potassium in your blood (hypokalemia).
- Heart failure. Taking certain diabetes pills called TZDs
(thiazolidinediones) with SOLIQUA 100/33 may cause heart failure in
some people. This can happen even if you have never had heart
failure or heart problems before. If you already have heart failure
it may get worse while you take TZDs with SOLIQUA 100/33. Tell your
healthcare provider if you have any new or worse symptoms of heart
failure including shortness of breath, swelling of your ankles or
feet, sudden weight gain.
The most common side effects of SOLIQUA 100/33 may
include:
- low blood sugar (hypoglycemia)
- nausea
- headache
- stuffy or runny nose and sore throat
- allergic reactions
- diarrhea
- upper respiratory tract infection
Nausea and diarrhea usually happen more often when you start
using SOLIQUA 100/33.
Please click here for full Prescribing Information for SOLIQUA
100/33 (insulin glargine & lixisenatide injection) 100 Units/mL
& 33 mcg/mL: www.soliqua100-33.com.
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 Consumer Healthcare.
Sanofi is listed in Paris
(EURONEXT: SAN) and in New York
(NYSE: SNY).
Reference
1. American Diabetes Association,
Diabetes Care Jan 2017, 40
(Supplement 1) S48-S56; DOI: 10.2337/dc17-S009.
2. Aroda VR, et al. Diabetes Care. 2016, DOI:
10.2337/dc16-1495.
Forward-Looking Statements
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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 regarding
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uncertainties include among other things, the uncertainties
inherent in research and development of the product, future
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ended December 31, 2016. Other than
as required by applicable law, Sanofi does not undertake any
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