LISBON, Portugal, Sept. 13, 2017 /PRNewswire-USNewswire/ -- In
a new analysis1 of late stage clinical
trials,2-4 adults with type 2 diabetes treated with
Sanofi's Toujeo® (insulin glargine 300 Units/mL,
Gla-300) achieved better blood glucose stability than those on
insulin glargine 100 Units/mL (Lantus®, Gla-100). These
improvements in blood glucose stability were statistically
significant in EDITION 2 and SENIOR, and for night-time
measurements in EDITION 3. The analysis was presented at the
European Association for the Study of Diabetes (EASD)
53rd annual meeting in Lisbon,
Portugal.
"The analysis used an innovative risk-based measure, the Low
Blood Glucose Index (LBGI), which was calculated using blood
glucose level data collected during the studies. This metric was
confirmed as a powerful predictor of documented symptomatic (< 3
mmol/L [54 mg/dL]) and severe hypoglycemia among the Glycemic
Variability measures tested.1 Its clinical relevance
lies in the fact that from simple self-measured blood glucose
values, it can identify patients who are at high risk of
hypoglycemia," said Boris
Kovatchev, Director, University of
Virginia Center for Diabetes Technology and Professor at the
University of Virginia School of
Medicine. "Patients treated with Gla-300 achieved lower blood
glucose variability and risk of documented symptomatic and severe
hypoglycemia, confirmed by LBGI values, consistently in all three
clinical trials. The hypoglycemia risk difference in favor of
Toujeo was most evident during the night."
"These data add to the consistent body of evidence around
Gla-300, which includes a continuous glucose monitoring (CGM)
study,3,5 and comparative observational studies like the
DELIVER program,6,7 in patients with type 2
diabetes," said Riccardo
Perfetti, Vice-President Global Medical Affairs, DCV Medical
Affairs, Sanofi.
About this Low Blood Glucose Index analysis
This study
re-analyzed patient-level data from the EDITION 2 and EDITION 3
clinical trials in adults with type 2 diabetes,2,3 and
the recently-completed SENIOR study in elderly patients with type 2
diabetes.4 Participants collected Self-Measured Blood
Glucose data throughout the study (8 times per day in the EDITION
studies, and 5 times per day in SENIOR). This was analyzed to
calculate glucose variability using a variety of measure, including
Low Blood Glucose Index (LBGI), a risk-based metric of glucose
variability in the hypoglycemic range, which was assessed alongside
documented symptomatic (< 3.3 mmol/L [54 mg/dL]) hypoglycemia
reported during the studies.
Table - Low Blood Glucose Index values in EDITION 2,
EDITION 3 and SENIOR studies
|
EDITION 2
(n=796)2*
|
EDITION 3
(n=839)3*
|
SENIOR
(n=1014)4*
|
|
Gla-300
|
Gla-100
|
Gla-300
|
Gla-100
|
Gla-300
|
Gla-100
|
LBGI
|
|
|
|
|
|
|
Titration
|
0.333
|
0.507
|
0.241
|
0.300
|
0.28
|
0.34
|
Maintenance
|
0.410
|
0.498
|
0.376
|
0.410
|
0.34
|
0.44
|
p-value
|
0.002
|
0.09
|
0.008
|
Night
LBGI
|
|
|
|
|
|
|
Titration
|
0.707
|
1.292
|
0.496
|
0.593
|
0.39
|
0.51
|
Maintenance
|
0.987
|
1.241
|
0.731
|
0.924
|
0.52
|
0.67
|
p-value
|
<0.001
|
0.02
|
0.008
|
* Participants
were included in this analysis only if they collected SMBG data
through the study.
|
The analysis demonstrated reductions in glucose variability and
hypoglycemia risk with Gla-300 compared with Gla-100; these were
statistically significant in EDITION 2 and SENIOR, and for
night-time measurements in EDITION 3. These risk differences were
most prominent overnight and were consistent across the titration
and maintenance periods for both EDITION 2 and EDITION 3
studies.
What is Toujeo® (insulin glargine injection) 300
Units/mL?
Prescription Toujeo® is a long-acting insulin used to
control blood sugar in adults with diabetes mellitus.
- Toujeo® contains 3 times as much insulin in 1 mL as
standard insulin (100 Units/mL)
- Toujeo® is not for use to treat diabetic
ketoacidosis
- Toujeo® should not be used in children
Important Safety Information for Toujeo® (insulin
glargine injection) 300 Units/mL
Do not take Toujeo® if you have low blood sugar or if
you are allergic to insulin or any of the ingredients in
Toujeo®.
Do NOT reuse needles or share insulin pens even if the needle
has been changed.
Before starting Toujeo®, 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 breastfeeding or planning to breastfeed.
Heart failure can occur if you are taking insulin together with
pills called TZDs (thiazolidinediones), even if you have never had
heart failure or other heart problems. If you have heart failure,
it may get worse while you take TZDs with
Toujeo®. Your treatment with TZDs and
Toujeo® 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 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, and herbal
supplements.
Toujeo should be taken at the same time once a day. Test your
blood sugar levels daily while using any insulin, including
Toujeo®. Do not change your dose or type of
insulin without talking to your doctor. Verify you have the correct
insulin before each injection. Do NOT use a syringe to remove
Toujeo® from your SoloStar® pen.
Your dose for Toujeo® may be different from other
insulins you have taken. Any change of insulin should be made
cautiously and only under medical supervision.
Do NOT dilute or mix Toujeo® with any other
insulin or solution. It will not work as intended and you may
lose blood sugar control, which could be serious. Use
Toujeo® only if the solution is clear and colorless with
no particles visible.
While using Toujeo®, do not drive or operate
heavy machinery until you know how Toujeo®
affects you. Don't drink alcohol or use other medicines that
contain alcohol.
The most common side effect of any insulin, including
Toujeo®, is low blood sugar (hypoglycemia), which may be
serious and can be life-threatening. Severe hypoglycemia may
cause harm to your heart or brain. Symptoms of serious low blood
sugar may include shaking, sweating, fast heartbeat, and blurred
vision.
Toujeo® may cause severe allergic reactions that can
lead to death. Get medical help right away if you have:
- A rash over your whole body
- Shortness of breath
- Swelling of your face, tongue, or throat
- Extreme drowsiness, dizziness, or confusion
- Trouble breathing
- Fast heartbeat
- Sweating
Toujeo® may have additional side effects including
swelling, weight gain, low potassium, and injection site reactions
which may include change in fat tissue, skin thickening, redness,
swelling, and itching.
Toujeo® SoloStar® is a disposable
prefilled insulin pen. Talk to your doctor about proper injection
technique and follow instructions in the Instruction Leaflet that
comes with the pen.
Please see full Prescribing Information for Toujeo®
on Toujeo.com or click here:
http://products.sanofi.us/Toujeo/Toujeo.pdf.
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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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 regarding
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ended December 31, 2016. Other than
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References
- B. Kovatchev et al, Glucose Variability and Risk for
Hypoglycemia on Glargine 300 U/mL vs Glargine 100 U/mL, evaluated
by the Low BG Index in Randomized Phase Ill Clinical Trials,
A-17-1332-EASD, Presentation #78, September
2017
- Yki-Järvinen H, et al. Diabetes Obes Metab. 2015;17(12):1142-9,
DOI: 10.1111/dom.12532.
- Bolli GB, et al. Diabetes & Metabolism (2017) in
press.
- Ritzel R et al. Poster #469 at 21st International Association
of Gerontology and Geriatrics (IAGG) World Congress, San Francisco, July
2017.
- Bergenstal RM, et al. Diabetes Care. 2017, DOI:
10.2337/dc16-0684.
- Zhou FL et al, Lower Risk of Hypoglycemia and Less Health Care
Utilization in Basal Insulin-Treated Patients with Type 2 Diabetes
(T2D) After Switching to Insulin Glargine 300 U/mL (Gla-300) vs
Other Basal Insulins in Real-World Clinical Settings, Poster NR
1151, American Association of Clinical Endocrinologists (AACE) 26th
Annual Scientific & Clinical Congress, Austin, TX, U.S., May 3–7 2017.
- Zhou FL et al, Older Adults with Type 2 Diabetes (T2D)
Experience Less Hypoglycemia When Switching to Insulin Glargine 300
U/mL (Gla-300) vs Other Basal Insulins (DELIVER 3 Study), Poster
986-P, American Diabetes Association (ADA) 77th Scientific
Sessions, San Diego, CA, U.S.,
June 10, 2017.
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