SAN DIEGO, June 10, 2017 /PRNewswire/ -- Sanofi
announced today new evidence from a real-world observational study
demonstrating significantly less risk of documented hypoglycemia
with similar blood sugar control after switching to
Toujeo® (insulin glargine 300 Units/mL) compared to
switching to another basal insulin including Lantus®
(insulin glargine 100 Units/mL), Levemir® (insulin
detemir) and Tresiba® (insulin degludec), in an at-risk
population of senior adults (aged ≥65 years) with type 2 diabetes.
The results of the DELIVER 3 retrospective observational study
comparing two cohorts were presented at the American Diabetes
Association (ADA) 77th Scientific Sessions Annual
Meeting in San Diego, CA, U.S.
In the DELIVER 3 study,1 patients switching to Toujeo
were 57 percent less likely to experience hypoglycemia at 6-month
follow-up (Odds Ratio: 0.432, 95% CI: 0.307 to 0.607, p<0.0001)
than those who switched to another basal insulin, with similar
glycemic control (least squares mean difference -0.09%,
p=0.24).
"Older patients with type 2 diabetes are disproportionately
impacted by hypoglycemia and its consequences," said
Jeremy Pettus, Assistant Professor,
Division of Endocrinology, University of
California, San Diego, U.S. "Observational real-world
data such as DELIVER 3 can contribute to clinical decision-making,
helping physicians to better advise their patients in this
important at-risk population."
These findings are broadly consistent with Toujeo evidence from
DELIVER 2, a retrospective observational study that included two
matched cohorts of 1,827 (n=3,654) adults with type 2 diabetes
using basal insulin who switched to either Toujeo or another basal
insulin. DELIVER 2 showed 33 percent fewer hypoglycemic events
after 6 months in a broader population of adults with type 2
diabetes, which contributed to an estimate of all-cause healthcare
cost savings of up to approximately $2,000 per patient per year.2
"The findings from DELIVER 2 and 3 demonstrate the real-life
clinical benefit of Toujeo vs other basal insulins, and how this
translates into overall cost savings. Complementing these
observational studies in a real-life setting, Sanofi is also
conducting a unique program of three randomized, prospective,
open-label real-life clinical studies with Toujeo," said
Riccardo Perfetti, Head of Global
Diabetes Medical Team, Sanofi. "The methodology of these
studies could provide a better understanding of the comparative
benefit of Toujeo vs. other basal insulins, and the findings might
be relevant to future clinical practice and evaluation of overall
cost of care."
These randomized, prospective real-life clinical studies, called
ACHIEVE CONTROL, REACH CONTROL and REGAIN CONTROL, involve more
than 4,500 people with type 2 diabetes across the U.S. and
Europe who are starting basal
insulin treatment or switching from another basal insulin. In
addition to clinical measures, the studies will also collect
patient feedback on treatment satisfaction and their experience of
hypoglycemia, along with impact on healthcare resource utilization.
Initial results are anticipated later in 2017.
Summary of DELIVER program
The DELIVER program
comprises several non-interventional retrospective analyses using
data from the Predictive Health Intelligence Environment (PHIE)
database of U.S. real-world electronic medical records, currently
representing 37 integrated health delivery networks. Hypoglycemia
was identified in the dataset by diagnosis code (ICD9/10 codes) or
plasma glucose (≤70mg/dL by laboratory test).
These findings represent actual prescribing patterns and
clinical outcomes outside the confines of a clinical trial, which
might include drug use outside U.S. Food and Drug Administration
(FDA)-approved prescribing information. As a result, reporting of
hypoglycemia at baseline and in both treatment arms were not based
on self-monitored blood glucose, which could result in less severe
events not being reported by patients. The limitations in the
DELIVER studies are similar to those generally observed in such
studies.
The DELIVER 31 retrospective observational study
included 1,610 people with type 2 diabetes aged ≥65 years on basal
insulin who switched to either Toujeo or another basal insulin
(insulin glargine 100 Units/mL, insulin detemir or insulin
degludec). Patients switching to Toujeo were 57 percent less
likely to experience hypoglycemia at 6-month follow-up (Odds Ratio:
0.432, 95% CI: 0.307 to 0.607, p<0.0001) than those who switched
to another basal insulin. Switching to Toujeo or another basal
insulin resulted in comparable changes in HbA1c (least
squares mean difference -0.09%, p=0.24).
The DELIVER 22 retrospective observational study
included two matched cohorts of 1,827 (n=3,654) adults with type 2
diabetes using basal insulin who switched to either Toujeo or
another basal insulin (insulin glargine 100 Units/mL, insulin
detemir or insulin degludec). After 6 months, patients who switched
to Toujeo experienced 25 percent fewer hypoglycemic events than
those who switched to other basal insulins (mean hypoglycemia event
rate per patient per year: 0.667 vs. 0.902; difference: -0.225
events per patient per year; p<0.01) with comparable blood
glucose control. Patients switching to Toujeo experienced
significantly fewer all-cause hospital in-patient days (least
squares mean difference: −0.714, 95% CI: −1.285 to −0.143, p=0.01),
emergency department visits (least squares mean difference: −0.177
events/PPPY, 95% CI: −0.319 to −0.036, p=0.01) and outpatient
events (least squares mean difference: −0.985 events/PPPY, 95% CI:
−1.610 to −0.359, p<0.01) during 6 months of follow-up compared
to patients who switch to another basal insulin, translating to
savings of $2,071 per patient per
year.
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).
References
- 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.
- 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.
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 regarding
the clinical development of and potential marketing approvals for
the product. Forward-looking statements are generally identified by
the words "expects", "anticipates", "believes", "intends",
"estimates", "plans", "will be" and similar expressions. Although
Sanofi's management believes that the expectations reflected in
such forward-looking statements are reasonable, investors are
cautioned that forward-looking 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 expressed in, or implied or projected by, the
forward-looking information and statements. These risks and
uncertainties include among other things, the uncertainties
inherent in research and development of the product, 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 the product as well as their decisions
regarding labeling and other matters that could affect the
availability or commercial potential of the product, the absence of
guarantee that the product if approved will be commercially
successful, risks associated with intellectual property, future
litigation, the future approval and commercial success of
therapeutic alternatives, and volatile economic conditions, as well
as those risks 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, 2016. Other than
as required by applicable law, Sanofi does not undertake any
obligation to update or revise any forward-looking information or
statements.
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