Tresiba® Demonstrated Significantly Improved Blood Sugar Control and Lower Rates of Hypoglycaemia Versus Insulin Glargine U300 in Real-World Evidence Study

Orlando, Florida (ots/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 (http://www.novonordisk.com/), Facebook
(http://www.facebook.com/novonordisk), Twitter
(http://www.twitter.com/novonordisk), LinkedIn
(http://www.linkedin.com/company/novo-nordisk), YouTube
(http://www.Youtube.com/novonordisk).

References

1. 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.
2. 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.
3. 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.
4. International Hypoglycaemia Study Group. Diagnosis of
hypoglycaemia. Available online at
http://ihsgonline.com/understanding-hypoglycaemia/diagnosis. Last
accessed: June 2018.
5. Cryer PE. Hypoglycemia, functional brain failure, and brain death.
J Clin Invest. 2007; 117:868-870.
6. Ahrén B. Avoiding hypoglycemia: a key to success for
glucose-lowering therapy in type 2 diabetes. Vasc Health Risk
Manag. 2013; 9:155-163.
7. Haahr H, Heise T. A review of the pharmacological properties of
insulin degludec and their clinical relevance. Clin Pharmacokinet.
2014; 53:787-800.
8. EMA. Tresiba® Summary of Product Characteristics. Available at: ht
tp://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_
Information/human/002498/WC500138940.pdf. Last accessed: June
2018.
9. 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

ots Originaltext: Novo Nordisk A/S
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