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

Bagsværd, Denmark (ots/PRNewswire) -

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® 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®. 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® 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® in people with
type 2 diabetes. After switching to Tresiba®, 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®.[3]

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.[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®
allows for flexibility in day-to-day dosing time with a minimum of
eight hours between injections.[4] 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 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® 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® 6 months prior to data
collection. Outcome measurements were collected at 6±3 and 12±3
months after initiation on Tresiba® and was compared to baseline
measurement taken from the prior basal insulin during a 3-month
period prior to initiation on Tresiba®.[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® were included. Measurements were
collected 90 days prior to, and 90±45 days after, initiating
Tresiba®.[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® Summary of Product Characteristics. Available at:
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_I
nformation/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® 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

Åsa Josefsson

+45-3079-7708

aajf@novonordisk.com
Investors:

Peter Hugreffe Ankersen

+45-3075-9085

phak@novonordisk.com

Hanna Ögren

+45-3079-8519

haoe@novonordisk.com

Anders Mikkelsen

+45-3079-4461

armk@novonordisk.com

Kasper Veje (US)

+1-609-235-8567

kpvj@novonordisk.com

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