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

PR74109

ORLANDO, Florida, June 24, 2018 /PRNewswire=KYODO JBN/ --

     Adults with type 2 diabetes treated with Tresiba(R) (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(R) (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(R) 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(R) 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(R) 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(R) for adults with type

2 diabetes."

    About the CONFIRM study

    The CONFIRM study is a retrospective, non-interventional comparative

effectiveness study that investigated Tresiba(R) and insulin glargine U300

(Toujeo(R)) 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(R) 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(R)

    Tresiba(R) (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(R) 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(R) 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.

     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

     Asa 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 Kjaer, +45-3079-3009, cnje@novonordisk.com

Source: Novo Nordisk