LOS ANGELES, Nov. 30, 2017 /PRNewswire/ -- Adults with
type 2 diabetes who switched their basal insulin therapy to
Toujeo® or insulin degludec, experienced similar numbers
of low blood sugar (hypoglycemia) events, according to the findings
of two comparative real-world studies. Patients also experienced
similar reduction of average blood sugar (HbA1c) with
the different insulin treatments.
The results were presented today at the World Congress on
Insulin Resistance, Diabetes & Cardiovascular Disease in
Los Angeles, CA,
U.S.1,2
The two studies, known as LIGHTNING and DELIVER D, are part of
the comparative study program for Toujeo versus insulin degludec.
Both studies were retrospective observational analyses based on two
different large U.S. databases of electronic medical records and
claims using a statistical technique (propensity score matching)
for making the treatment groups comparable. This minimizes observed
sources of bias typically found in simple observational
studies.
"With the patient matching approach used in the two studies,
physicians and payers will have access to additional findings to
evaluate Toujeo in a real-life setting," said Riccardo Perfetti, Head of Global Diabetes
Medical Team, Sanofi. "Data evaluating the risk of severe low
blood sugar (hypoglycemia) can also help educate providers on
treatment options."
LIGHTNING: The largest real-world comparative study in
diabetes
The LIGHTNING retrospective observational study1 is
the largest real-world comparative study in diabetes. It used
statistical techniques, such as propensity score matching and
predictive modeling, to evaluate electronic medical records for
130,155 adult patients who were treated with long-acting insulin
treatment in the U.S. Optum-Humedica database.
After Propensity Score Matching (PSM), 8,456 adult patients with
type 2 diabetes who switched from using insulin glargine 100
Units/mL to Toujeo or insulin degludec were compared in a routine
care setting. The majority of patient baseline characteristics were
similar across basal insulin treatment groups. Analysis showed that
the risk of severe hypoglycemia related to an inpatient or
emergency department visit was comparable in both groups of
patients (p=0.37) with no differences in HbA1c.
DELIVER D: Further results from the DELIVER comparative
program
In the DELIVER D retrospective observational study2,
it used electronic medical records (EMR) for 22,492 adult patients
who were treated with long-acting insulin treatment in the U.S.
Predictive Health Intelligence Environment (PHIE) database. After
PSM, 1,620 adult patients with type 2 diabetes who switched from
using insulin glargine 100 Units/mL to Toujeo or insulin degludec
were compared in a routine care setting. The majority of patient
baseline characteristics were similar across basal insulin
treatment groups.
During the 6-month follow-up period, patients in both groups
showed comparable numbers of patients experiencing any low blood
sugar (hypoglycemia) events (p=0.45). The number of patients
experiencing low blood sugar events associated with hospital or
emergency department visit was also similar in both groups
(p=0.80). Reduction in average blood sugar levels
(HbA1c) were comparable between the two groups (p=0.97).
Patients on Toujeo and those on insulin degludec were equally
likely to attain HbA1c < 7.0% (12.9% vs 15.9%,
respectively; P = 0.24) and HbA1c < 8.0% (44.2% vs
44.6%, respectively; P = 0.92) during 3-6 months' follow-up.
While the findings from both studies represent actual patterns
of treatment and outcomes outside the confines of clinical trials,
electronic medical records are not completed for research purposes
and vary in completeness. As a result limitations of these analyses
include potential incomplete dosage information, under-reporting of
hypoglycemia, and lack of information about reasons for switching
treatment. In addition, the PSM process results in a smaller
overall dataset compared with the available patient data pool.
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.
References
- Zhou LF et al, "Hypoglycemia risk associated with basal insulin
use in type 2 diabetes (T2DM): The Lightning study", World Congress
on Insulin Resistance, Diabetes & Cardiovascular Disease in
Los Angeles, CA, U.S.,
November 30 – December 2.
- Blonde L et al, "Real-world evidence demonstrates comparable
clinical outcomes of switching from insulin glargine 100 U/mL
(Gla-100) to insulin glargine 300 U/mL (Gla-300) vs insulin
degludec (IDeg) in patients with type 2 diabetes (T2D)", World
Congress on Insulin Resistance, Diabetes & Cardiovascular
Disease in Los Angeles, CA, U.S.,
November 30 – December 2.
About Sanofi
Sanofi is dedicated to supporting people through their health
challenges. We are a global biopharmaceutical company focused on
human health. We prevent illness with vaccines, provide innovative
treatments to fight pain and ease suffering. We stand by the few
who suffer from rare diseases and the millions with long-term
chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is
transforming scientific innovation into healthcare solutions around
the globe.
Sanofi, Empowering Life
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