ORLANDO, Florida, June 23, 2018 /PRNewswire/ --
Adults with type 2 diabetes treated with
Tresiba® (insulin degludec
injection) had
a significant reduction
in HbA1c and a 30% lower
rate
of hypoglycaemic episodes after starting basal insulin
Findings from CONFIRM - a large real-world evidence (RWE) study
comparing the effectiveness of Tresiba® (insulin
degludec injection) versus insulin glargine U300 - will be
presented on Monday, 25 June 2018 at
the American Diabetes Association's 78th Scientific
Sessions (ADA) in Orlando, US. The
retrospective, non-interventional comparative effectiveness study,
which included 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 HbA1c compared to those treated
with insulin glargine U300 (-1.5% vs. -1.2% respectively;
p=0.029).[1]
As a secondary endpoint, there was a 30% lower rate of
hypoglycaemic episodes with Tresiba® compared to
insulin glargine U300 (p=0.045).[1] In this study,
hypoglycaemic events, ranging from mild to severe, were registered
using the International Classification of Diseases (ICD) codes 9/10
following diagnosis from a physician.[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
U300 had a 37% higher rate of discontinuing treatment after two
years (p<0.001).[1]
"Real-world studies are important to understanding how clinical
trials may translate into real value for patients in everyday
clinical practice," said Todd Hobbs,
vice president and US chief medical officer of Novo Nordisk. "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 U300
(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 U300
according to local practice. Electronic health records were sourced
from multiple health systems in the US. The primary endpoint was
change in HbA1c (blood sugar control) from baseline
to six months follow-up. Secondary endpoints included rate of
hypoglycaemia, proportion of patients with at least one
hypoglycaemic episode and the rate of treatment
discontinuation.
As with all real-world studies, CONFIRM was not randomised and
it carries the limitations of real-world evidence. This includes
potential under-reporting of hypoglycaemia (however, this is the
case in both treatment arms in CONFIRM meaning that the rate ratio
as well as the odds ratio are expected to be preserved), and the
short follow-up period of 3-6 months (though this corresponds to
when the largest changes in HbA1c tend to occur and
is commonly used in many trials). Additionally, in CONFIRM there is
only evidence of prescribed basal insulin and not actual use
(whether the medication was picked up at the pharmacy).
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® (insulin degludec) is a once-daily
basal insulin that provides a duration of action beyond 42 hours
with a flat and stable glucose-lowering
effect.[7],[8] It has been shown to provide a lower
risk of overall, nocturnal and severe hypoglycaemia, and low
variability in blood sugar levels versus insulin glargine
U100.[8],[9] Tresiba® received its
first regulatory approval in September
2012 and has since been approved in more than 80 countries
globally. It is now commercially available in more than 61
countries.
About Novo Nordisk
Novo Nordisk is a global healthcare company with 95 years of
innovation and leadership in diabetes care. This heritage has given
us experience and capabilities that also enable us to help people
defeat obesity, haemophilia, growth disorders and other
serious chronic diseases. Headquartered in Denmark, Novo Nordisk employs approximately
42,700 people in 79 countries and markets its products in more than
170 countries. For more information,
visit novonordisk.com, Facebook, Twitter,
LinkedIn, YouTube.
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 Asosciation (ADA), Orlando,
Florida, US; 22-26 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.
- Haahr H, Heise T. A review of the pharmacological properties of
insulin degludec and their clinical relevance. Clin
Pharmacokinet. 2014; 53:787-800.
- EMA. Tresiba® Summary of Product
Characteristics. Available
at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002498/WC500138940.pdf.
Last accessed: June 2018.
- Marso SP, McGuire DK, Zinman B, et al. Efficacy and
safety of degludec versus glargine in type 2 diabetes. N
Engl J Med. 2017; 377:723-732.
Further information
Media:
Katrine Sperling,
+45-4442-6718, krsp@novonordisk.com
Åsa Josefsson, +45-3079-7708, aajf@novonordisk.com
Michael Bachner (US),
+1-609-664-7308, mzyb@novonordisk.com
Investors:
Peter Hugreffe Ankersen,
+45-3075-9085, phak@novonordisk.com
Anders Mikkelsen,
+45-3079-4461, armk@novonordisk.com
Christina Kjær, +45-3079-3009, cnje@novonordisk.com