LISBON, Portugal, Sept. 14, 2017 /PRNewswire/ -- A new
randomized clinical trial, TAKE CONTROL1, demonstrated
better control of blood sugar (HbA1c) without increasing
the risk of hypoglycemia in people with type 2 diabetes (T2D) by
using Toujeo® (insulin glargine 300 Units/mL, Gla-300)
with a simple dose titration regimen ("patient-driven titration")
compared with patients whose dose adjustment was managed by their
physician ("physician-driven titration").
Participants initiated basal insulin with Toujeo or switched to
Toujeo from another basal insulin (including insulin glargine 100
Units/mL, insulin detemir and NPH), while maintaining any
previously administer oral antidiabetic drugs (OADs). After 6
months, patients with type 2 diabetes who used patient-driven
titration achieved improvement of HbA1c (LS mean
difference 0.13%, p=0.0247) compared with those who followed
physician-driven titration. The proportion of patients reaching the
pre-defined blood glucose target without experiencing severe and/or
confirmed hypoglycemia was 67.5% in the patient-driven titration
group, compared with 58.4% in the group using physician-driven
titration (RR 1.15 [1.02; 1.3], p=0.0187). Similar proportions of
patients in both groups (6.4% vs. 6.3%), experienced at least one
severe and/or confirmed (<54 mg/dL) hypoglycemic event. Full
results will be presented in 2018.
"The results of the TAKE CONTROL study demonstrate that
patients can make a critical contribution to work toward their own
effective blood sugar target when they are well trained and using a
basal insulin such as Toujeo," said Riccardo Perfetti, Vice-President Medical
Affairs, DCV Medical Affairs, Sanofi.
Sanofi is conducting a vast comparative Real-World program in
routine clinical practice that covers more than 200,000 patients
from U.S. and EU databases. Comparative data in a real-world
setting can be relevant for payors and other organizations
evaluating how findings from clinical trials can be translated into
day-by-day management of diabetes. Two comparative retrospective
observational studies, DELIVER 22 and DELIVER
33, have been presented previously. Additional
Real-World Evidence is expected to be submitted for publication
this year.
TAKE CONTROL design and study results
TAKE CONTROL is
a 24 weeks, open-label, 1:1 ratio randomized, controlled, 2-arm
parallel-group, multicenter, multinational study, comparing Gla-300
treatment of people with uncontrolled type 2 diabetes (T2DM), based
on a titration algorithm managed by the patient vs Gla-300
treatment based on a titration algorithm managed by the physician.
The primary objective was to demonstrate non-inferiority in terms
of glycemic control, measured as change from baseline to Week 24 in
HbA1c. Patients remained on any previously-taken oral
antidiabetic drugs (OADs).
This study included 631 patients with uncontrolled T2DM at
screening (62% on basal insulin, 38% insulin-naive), a mean age of
63 years old and a median duration of diabetes of 12 years. The
difference in mean HbA1c reduction was -0.13% in favor
of patient-driven titration (p<0.0001 for non-inferiority; a
subsequent test calculated p=0.0247 for superiority, meeting a
requirement of p=0.025). The percentage of patients achieving
composite endpoint (defined as a secondary endpoint) of reaching
the pre-defined fasting self-measured plasma glucose (SMPG) target
of 80-130mg/dL without experiencing severe and/or confirmed
hypoglycemia at week 24, was in favor of patient-driven titration
group. Overall, at least one episode of hypoglycemia was reported
by 36.2% of patients in the patient-driven titration group and by
37.0% of patients in the physician-driven titration group. Severe
hypoglycemia was reported in 0.6% of patients in the patient-driven
titration group, and 0.3% of patients [0.3%] in the
physician-driven titration group.
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
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
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Sanofi's management believes that the expectations reflected in
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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.
References
- Sanofi, data on file: TAKE CONTROL study, EUdraCT number
2015-001626-42, September 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.
- 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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