Switching to Tresiba(R) Provides Significant Reductions in Blood Glucose and Lower Rates of Hypoglycaemia in a Real-world Setting

PR68865

BAGSVAERD, Denmark, June 11, 2017 /PRNewswire=KYODO JBN/ --

    Poster Presentations #999-P, #1010-P, #1014-P

    Findings from the real-world study, EU-TREAT (EUropean TREsiba AudiT), were

presented today at the American Diabetes Association's 77th Scientific Sessions

(ADA) in San Diego, US. The study showed that people with type 1 diabetes and

type 2 diabetes experienced a significant reduction in HbA1c (-0.2% for type 1

diabetes and -0.5% for type 2 diabetes) six months after switching to

Tresiba(R) from another basal insulin, primarily insulin glargine U100 and

insulin detemir, in a real-world setting. These results were sustained at 12

months.[1],[2]

    Rates of overall hypoglycaemia were also significantly lower at six months

after switching to Tresiba(R). In people with type 1 diabetes, the rate of

severe hypoglycaemia was reduced by 85% and by 92% in people with type 2

diabetes. Hypoglycaemia outcomes at 12 months were in line with these

results.[1],[2]

    In addition, a significant reduction in fasting plasma glucose was observed

at six months (-18.7 mg/dL for type 1 diabetes, and -23.7 mg/dL for type 2

diabetes) and maintained for 12 months.[1],[2] The total daily insulin dose

also decreased significantly in people with type 1 diabetes (-4.9 units) and

type 2 diabetes (-2.5 units) at six months, and remained stable at 12

months.[1],[2]

    "Real-world studies are important to understand how outcomes from clinical

trials translate into real-world practice," said Mads Krogsgaard Thomsen,

executive vice president and chief science officer at Novo Nordisk. "Our

real-world data presented at ADA reinforce what we have seen in the clinical

trial programme, demonstrating improved glycaemic control and significantly

reduced risk of hypoglycaemia when patients switched to Tresiba(R) from other

basal insulins such as insulin glargine and insulin detemir."

    Also presented at ADA were analyses from the US, using the IBM Explorys

platform, that similarly assessed the clinical effectiveness of switching from

any other basal insulin to Tresiba(R) in people with type 2 diabetes. After

switching to Tresiba(R), HbA1c decreased significantly (-0.75%), and the

percentage of people reaching their target HbA1c of ＜7% more than doubled

(increased from 5.3% to 12.4% at 90 days). In addition, the proportion of

people who experienced one or more hypoglycaemic events decreased from 7.3% to

6.9% with Tresiba(R).[3]

    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.[4],[5] It provides low within-day and day-to-day variability and a

lower risk of overall, nocturnal and severe hypoglycaemia vs. insulin glargine

U100.[4],[6] On occasions when administration at the same time of day is not

possible, Tresiba(R) allows for flexibility in day-to-day dosing time with a

minimum of eight hours between injections.[4] 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 50

countries.

    About EU-TREAT   

    EU-TREAT (EUropean TREsiba AudiT) is a European, multicentre, real-world

evidence study (n=2,550) investigating the effect of switching to Tresiba(R)

from any other basal insulin in people with type 1 (n=1,717) and type 2 (n=833)

diabetes. Patients were switched from any other basal insulin to Tresiba(R) 6

months prior to data collection. Outcome measurements were collected at 6plus

or minus3 and 12plus or minus3 months after initiation on Tresiba(R) and was

compared to baseline measurement taken from the prior basal insulin during a

3-month period prior to initiation on Tresiba(R).[1],[2]

    About the US real-world study   

    The US real-world analysis is a retrospective cohort analysis using

anonymised electronic records, medical billing and payor claims data from the

IBM Explorys platform for people with type 2 diabetes (n=225). The IBM Explorys

platform is a database which combines patient data from different sources

across clinically integrated networks. People with type 2 diabetes who used a

basal insulin 90 days prior to initiating Tresiba(R) were included.

Measurements were collected 90 days prior to, and 90plus or minus45 days after,

initiating Tresiba(R).[3]

    Novo Nordisk is a global healthcare company with more than 90 years of

innovation and leadership in diabetes care. This heritage has given us

experience and capabilities that also enable us to help people defeat other

serious chronic conditions: haemophilia, growth disorders and obesity.

Headquartered in Denmark, Novo Nordisk employs approximately 42,000 people in

77 countries and markets its products in more than 165 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. Siegmund T, Tentolouris N, Knudsen TS, et al. EU-TREAT 1: Switching to

insulin degludec reduces the risk of hypoglycaemia in patients with T1DM in a

real-world setting. Poster presentation. 77th  American Diabetes Association

(ADA), San Diego, California, US. June 2017.

    2. Schultes B, Tentolouris N, Knudsen TS, et al.EU-TREAT 2: Switching to

insulin degludec improves glycaemic control in patients with T2DM in a

real-world setting. Poster presentation. 77thAmerican Diabetes Association

(ADA), San Diego, California, US. June 2017.

    3. Tibaldi J, Hansen B, Wolden ML, et al. Real-world assessment of clinical

effectiveness when switching to insulin degludec from another basal insulin

among type 2 diabetes patients in the US. Poster presentation. 77th American

Diabetes Association (ADA), San Diego, California, US. June 2017.

    4. 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: May 2017.

    5. Haahr H, Heise T. A review of the pharmacological properties of insulin

degludec and their clinical relevance. Clinical Pharmacokinetics. 2014;

53:787-800.

    6. Novo Nordisk. Tresiba(R) demonstrates a safe cardiovascular profile and

reduces the risk of severe hypoglycaemia compared to insulin glargine U100 in

the DEVOTE trial. Company announcement 29 November 2016. Available at:

http://www.novonordisk.com/media.html. Last accessed: May 2017.

    Further information

    Media:

    Katrine Sperling

    +45-4442-6718

    krsp@novonordisk.com

    Asa Josefsson

    +45-3079-7708

    aajf@novonordisk.com  

    Investors:

    Peter Hugreffe Ankersen

    +45-3075-9085

    phak@novonordisk.com

    Hanna Ogren

    +45-3079-8519

    haoe@novonordisk.com

    Anders Mikkelsen

    +45-3079-4461

    armk@novonordisk.com

    Kasper Veje (US)

    +1-609-235-8567

    kpvj@novonordisk.com

SOURCE: Novo Nordisk