LISBON, Portugal, Sept. 12, 2017 /PRNewswire/ -- In certain
adults with type 2 diabetes, Sanofi's Soliqua® 100/33
(insulin glargine & lixisenatide injection, 100 Units/mL &
33 mcg/mL) provided blood sugar control earlier and in more adults
than those treated with insulin glargine 100 Units/mL alone,
according to a new post-hoc analysis of key late-stage clinical
trials.
"Reaching an HbA1c target quickly can have a
benefit for adults with type 2 diabetes," said Dr. Juan Frias, President and Principal Investigator
of the National Research Institute in Los
Angeles, California, U.S. "Early, effective glycemic
control can lead to better outcomes, both clinically and in terms
of the overall cost of care."
The analysis was presented today at the European Association for
the Study of Diabetes (EASD) 53rd Annual Meeting, in
Lisbon, Portugal. The abstract is
titled "Shorter time to glycaemic control with fixed-ratio
combination of insulin glargine and lixisenatide compared with
insulin glargine treatment alone" (Frias J.P. et al. Poster
presentation #803).
Summary of analysis
This post-hoc analysis
reviewed data from the Phase 3 trials, LixiLan-O and
LixiLan-L,1,2 which compared the effectiveness of
Soliqua 100/33 vs. insulin glargine 100 Units/mL on top of
metformin (if previously taken) in more than 1,900 adults with type
2 diabetes (LixiLan-O n=1,170 and LixiLan-L n=736). Primary results
and safety information for both studies were previously
reported.1,2 Blood glucose levels were evaluated at 8
and 12 weeks, and the Kaplan-Meier method was used to estimate time
to control, defined as time (days) to first achieve an
HbA1c of less than 7 percent or fasting plasma glucose
(FPG) of less than or equal to 7.2 mmol/L (130 mg/dL).
Table.
Achievement of glycemic control targets in the LixiLan-O and
LixiLan-L trials (safety population)
|
|
iGlarLixi
|
iGlar
|
|
iGlarLixi
|
iGlar
|
LixiLan-O*
|
N=469
|
N=467
|
LixiLan-L*
|
N=365
|
N=365
|
HbA1c
<7%
|
|
|
HbA1c
<7%
|
|
|
Patients achieving target, n
(%)†
|
|
|
Patients achieving target, n
(%)†
|
|
|
n
|
468
|
466
|
n
|
366
|
365
|
At 8
weeks
|
186 (39.7)
|
128 (27.5)
|
At 8
weeks
|
116 (31.7)
|
73 (20.0)
|
At 12
weeks
|
279 (59.6)
|
209 (44.8)
|
At 12
weeks
|
168 (45.9)
|
87 (23.8)
|
Days to first HbA1c <7%, median‡
|
85.0
|
166.0
|
Days to first HbA1c <7%, median‡
|
153.0
|
NR
|
HR (95% CI)§
|
1.5 (1.3,
1.7)
|
HR (95% CI)§
|
2.0 (1.7,
2.5)
|
p-value
|
<0.0001
|
p-value
|
<0.0001
|
FPG ≤7.2
mmol/L
|
|
FPG ≤7.2
mmol/L
|
|
|
Days to first FPG ≤7.2 mmol/L,
median‡
|
56.0
|
57.0
|
Days to first FPG ≤7.2 mmol/L,
median‡
|
1.0
|
1.0
|
HR (95% CI)§
|
1.1 (1.0,
1.2)
|
HR (95% CI)§
|
0.9 (0.8,
1.1)
|
p-value
|
0.2134
|
p-value
|
0.2137
|
|
|
|
|
|
|
|
|
*In both LixiLan-O and LixiLan-L, drug titrations were based
on the same algorithm.
†Responder analysis based on the mITT
population: estimated by proportion of patients achieving targets
at Weeks 8 and 12. ‡Median time to control: defined as
50% of patients reaching target as estimated by the Kaplan-Meier
method. §Estimated using Cox regression model with
treatment as the only factor. Calculated using the log-rank test.
FPG, fasting plasma glucose; mITT, modified intent-to-treat; NR,
not reached (i.e. target no reached by 50% of patients).
Soliqua 100/33, which is used in the U.S. in conjunction with
diet and exercise, is marketed as Suliqua® in the
EU.
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, or 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 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 problems with your pancreas, your kidneys, or
your liver, stones in your gallbladder, or a history of
alcoholism.
- 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 breastfeeding or plan to become pregnant or to
breastfeed. It is not known if SOLIQUA 100/33 will harm your unborn
baby or pass 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. Before using SOLIQUA 100/33,
talk to your healthcare provider about low blood sugar and how to
manage it.
How should I use SOLIQUA 100/33?
- Do not change your dose without first talking to your
healthcare provider.
- 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. Do not take SOLIQUA 100/33 with other GLP-1 receptor
agonists.
- 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 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. Stop taking SOLIQUA 100/33
and get help right away if you have any symptoms of a serious
allergic reaction, including 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, dizziness, drowsiness, confusion, weakness,
irritability, hunger, sweating, fast heartbeat, and feeling
jittery.
- 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), stuffy or runny nose
and sore throat, upper respiratory tract infection, headache,
allergic reactions, nausea, and diarrhea. 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).
Sanofi Forward-Looking Statements
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defined in the Private Securities Litigation Reform Act of 1995, as
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References
- Aroda VR, et al. Diabetes Care. 2016, DOI:
10.2337/dc16-1495.
- Rosenstock J. et al. Diabetes Care Aug
2016, dc160917; DOI: 10.2337/dc16-0917.
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