ORLANDO, Fla., June 23, 2018 /PRNewswire/ -- Findings from
CONFIRM – a large, retrospective real-world evidence (RWE) study
comparing the effectiveness of Tresiba® (insulin
degludec injection) 100 U/mL, 200 U/mL versus insulin glargine
U-300 in more than 4,000 adults with type 2 diabetes who were
starting basal insulin for the first time showed that after six
months those treated with Tresiba® had significantly
lower A1C compared to those treated with insulin glargine U-300
(-1.5% vs -1.2% respectively; p=0.029).1 The full
results will be presented on Monday, June
25 at the American Diabetes Association's 78th
Scientific Sessions (ADA) in Orlando,
Fla.
As a secondary endpoint, there was a 30% lower rate of
hypoglycaemic episodes with Tresiba® compared to insulin
glargine U-300 (p=0.045).1 In this study, hypoglycaemic
events were registered using the International Classification of
Diseases (ICD) codes 9/10 following diagnosis from a health care
provider.2
This real-world study also showed in another secondary endpoint
that people treated with Tresiba® were more likely to
stay on their treatment. Those treated with insulin glargine
U-300 had a 37% higher rate of discontinuing treatment after
two years (p<0.001).1
"Real-world studies, such as CONFIRM, are important to
understand how clinical trials may translate to patients in
everyday clinical practice," said Todd
Hobbs, vice president and US chief medical officer of Novo
Nordisk. "One of the most feared complications for people living
with diabetes is hypoglycaemia, and the CONFIRM results add to the
body of evidence on Tresiba® for adults with type 2
diabetes."
About the CONFIRM study
The CONFIRM study is a
retrospective, non-interventional comparative effectiveness study
that investigated Tresiba® and insulin glargine U-300
(Toujeo®) in 4,056 insulin-naïve (defined as no evidence
of basal insulin use at least 365 days prior to index date) adults
with type 2 diabetes in the US. Study groups were equal in size (n
= 2,028) and patients in each group were comparable after matching
for baseline characteristics. Patients were uncontrolled on one or
more oral antidiabetic drugs or a GLP-1 (glucagon-like peptide-1
receptor agonist) and prescribed Tresiba® or insulin
glargine U-300 according to local practice. Electronic health
records were sourced from multiple health systems in the US. The
primary endpoint was change in A1C (blood sugar control) from
baseline to six months follow-up. Secondary endpoints included rate
of hypoglycaemia, proportion of patients with at least one
hypoglycaemia episode and the rate of treatment
discontinuation.
As with all real-world studies, CONFIRM was not randomized and
it carries the limitations of real-world evidence. This includes
potential underreporting of hypoglycaemia (however, this is the
case in both treatment arms in CONFIRM meaning that the rate ratio
as well as the odds ratio is expected to be preserved); the short
follow-up period of 3-6 months (though corresponds to when the
largest changes in A1C tend to occur and is commonly used in
many trials). Additionally, in CONFIRM, there is only insight into
evidence of prescribed basal insulin and not actual use.
About hypoglycaemia
Hypoglycaemia occurs when blood
sugar levels are too low and cannot provide the body's organs with
the energy they need. Hypoglycaemia can cause a range of symptoms
including confusion, trembling, sweating, increased heart rate,
difficulty with concentration and speech and in severe cases can
lead to a seizure or coma.3-6
About Tresiba®
Tresiba® is a
long-acting insulin approved for type 1 and type 2 diabetes in
children as young as 1 year of age. Once-daily Tresiba®
is available in Novo Nordisk's insulin delivery device –
FlexTouch®, a 100 units/mL or 200 units/mL pen.
Tresiba® U-100 FlexTouch® can deliver up to
80 units of insulin in a single injection. Tresiba®
U-200 FlexTouch® can dose up to 160 units in a single
injection.
Tresiba® was approved by the FDA in the United States on September 25, 2015.
What is Tresiba®?
- Prescription Tresiba® is a long-acting insulin used
to control high blood sugar in adults and children who are 1 year
of age and older with diabetes
- Tresiba® is not for people with diabetic
ketoacidosis
- Tresiba® is not for children who need less than 5
units of Tresiba® each day
- It is not known if Tresiba® is safe and effective in
children under 1 year of age
- Tresiba® is available in 2 concentrations: 200
units/mL and 100 units/mL
Do not share your Tresiba® FlexTouch®
with other people, even if the needle has been changed. You may
give other people a serious infection, or get a serious infection
from them.
Who should not take Tresiba®?
Do not
take Tresiba® if you:
- are having an episode of low blood sugar
- are allergic to Tresiba® or any of the ingredients
in Tresiba®
Before taking Tresiba®, tell your health care
provider about all your medical conditions, including if you
are:
- pregnant, planning to become pregnant, or are
breastfeeding
- taking new prescription or over-the-counter medicines,
vitamins, or herbal supplements
Talk to your health care provider about low blood sugar and
how to manage it.
How should I take Tresiba®?
- Read the Instructions for Use and take
Tresiba® exactly as your health care provider tells you
to
- Do not do any conversion of your dose. The dose counter
always shows the selected dose in units
- Know the type and strength of insulin you take. Do not
change the type of insulin you take unless your health care
provider tells you to
- Adults - If you miss or are delayed in taking your dose of
Tresiba®:
-
- Take your dose as soon as you remember, then continue with your
regular dosing schedule
- Make sure there are at least 8 hours between doses
- If children miss a dose of Tresiba®:
-
- Call the healthcare provider for information and instructions
about checking blood sugar levels more often until the next
scheduled dose of Tresiba®
- Check your blood sugar levels. Ask your health care
provider what your blood sugar levels should be and when you should
check them
- Do not reuse or share your needles with other people.
You may give them a serious infection, or get a serious infection
from them
- Never inject Tresiba® into a vein or
muscle
- Never use a syringe to remove Tresiba® from
the FlexTouch® pen
What should I avoid while taking Tresiba®?
- Do not drive or operate heavy machinery, until you know
how Tresiba® affects you
- Do not drink alcohol or use prescription or
over-the-counter medicines that contain alcohol
What are the possible side effects of
Tresiba®?
Tresiba® may cause
serious side effects that can be life-threatening,
including:
- Low blood sugar (hypoglycemia). Signs and symptoms that
may indicate low blood sugar include anxiety, irritability, mood
changes, dizziness, sweating, confusion, and headache
- Low potassium in your blood (hypokalemia)
- Heart failure in some people if taken with
thiazolidinediones (TZDs). This can happen even if you have never
had heart failure or heart problems. If you already have heart
failure, it may get worse while you take TZDs with
Tresiba®. Tell your health care provider if you
have any new or worse symptoms of heart failure including shortness
of breath, tiredness, swelling of your ankles or feet, and sudden
weight gain
Your insulin dose may need to change because of change in
level of physical activity or exercise, increased stress, change in
diet, weight gain or loss, or illness.
Common side effects may include reactions at the
injection site, itching, rash, serious allergic reactions (whole
body reactions), skin thickening or pits at the injection site
(lipodystrophy), weight gain, and swelling of your hands and
feet.
Get emergency medical help if you have trouble breathing,
shortness of breath, fast heartbeat, swelling of your face, tongue,
or throat, sweating, extreme drowsiness, dizziness, or
confusion.
Please see Prescribing Information for
Tresiba® at
http://www.novo-pi.com/tresiba.pdf.
About Novo Nordisk
Novo Nordisk, a
global healthcare company, has been committed to discovering and
developing innovative medicines to help people living with diabetes
lead longer, healthier lives for 95 years. This heritage has given
us experience and capabilities that also enable us to help people
defeat other serious diseases including obesity, hemophilia and
growth disorders. We remain steadfast in our conviction that the
formula for success is to stay focused, think long term and do
business in a financially, socially and environmentally responsible
way. With U.S. headquarters in New
Jersey and production and research facilities in four
states, Novo Nordisk employs nearly 6,000 people throughout the
country. For more information, visit novonordisk.us,
Facebook and Twitter.
References
- Tibaldi J, Haldrup S, Sandberg V, et al. Clinical
Outcome Assessment of the Effectiveness of Insulin Degludec
(Degludec) in Real-life Medical Practice (CONFIRM): A Comparative
Effectiveness Study of Degludec and Insulin Glargine 300U/mL
(Glargine U300) in 4,056 Insulin-Naïve Patients with Type 2
Diabetes (T2D) Oral/poster presentation. 78th Annual
Scientific Sessions of the American Diabetes Association (ADA),
Orlando, Florida, US. June 2018.
- Ginde AA, Blanc PG, Lieberman RM, et al. Validation of
ICD-9-CM coding algorithm for improved identification of
hypoglycemia visits. BMC Endocr Disord. 2008;8:4.
- Seaquist ER, Anderson J, Childs B, et al. Hypoglycemia
and diabetes: a report of a workgroup of the American Diabetes
Association and the Endocrine Society. Diabetes Care.
2013;36:1384-1395.
- International Hypoglycaemia Study Group. Diagnosis of
hypoglycaemia. Available online at
http://ihsgonline.com/understanding-hypoglycaemia/diagnosis. Last
accessed: June 2018.
- Cryer PE. Hypoglycemia, functional brain failure, and brain
death. J Clin Invest. 2007;117:868-870.
- Ahrén B. Avoiding hypoglycemia: a key to success for
glucose-lowering therapy in type 2 diabetes. Vasc Health Risk
Manag. 2013;9:155-163.
Tresiba® and FlexTouch® are registered
trademarks of Novo Nordisk A/S.
Novo Nordisk is a registered trademark of Novo Nordisk A/S.
All other trademarks, registered or unregistered, are the property
of their respective owners.
© 2018 Novo
Nordisk All rights
reserved.
USA18TSM01286 June 2018
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SOURCE Novo Nordisk