2017年9月14日

Novo Nordisk

Xultophy(R) Reduces Cardiovascular Risk Factors in People with Type 2 Diabetes

Xultophy(R) Reduces Cardiovascular Risk Factors in People with Type 2 Diabetes

PR70038

LISBON, Portugal, September 14, 2017 /PRNewswire=KYODO JBN/ —

     Oral Presentation 113

    In people with type 2 diabetes, Xultophy(R) (insulin degludec/liraglutide)
significantly reduced a number of risk factors associated with an increased
risk of cardiovascular disease (CVD), compared to basal insulin.[1]

    According to a new post-hoc analysis presented today at the 53rd Annual
Meeting of the European Association for the Study of Diabetes (EASD 2017),
people treated with Xultophy(R)  had significantly lower systolic blood
pressure, lower total cholesterol as well as lower low-density lipoprotein
cholesterol (so-called ‘bad cholesterol’), and significant weight changes in
favour of Xultophy(R) compared to people treated with basal insulin (insulin
glargine U100 or insulin degludec). A small but statistically significant
increase in heart rate was also observed with Xultophy(R).[1]

    "People with type 2 diabetes have a higher risk of a heart attack or stroke
compared to the general population, so reducing this risk as much as possible
should be a central goal of treatment", said Professor Tina Vilsboll, Steno
Diabetes Center Copenhagen, Denmark & Center for Diabetes Research, Gentofte
Hospital, Copenhagen, Denmark. "I am very pleased to see the beneficial effects
on cardiovascular risk markers provided by Xultophy (R)."

    CVD is the principal cause of death and disability among people with type 2
diabetes globally, with approximately two-thirds of deaths in people with
diabetes attributable to CVD.[2] Therefore, treatments for type 2 diabetes
should not only lower blood sugar levels but also decrease CV risk.[3]

    "This added benefit of Xultophy(R) is certainly great news for the
population at risk of developing cardiovascular disease on top of their
existing type 2 diabetes", said Mads Krogsgaard Thomsen, executive vice
president and chief science officer of Novo Nordisk. "At Novo Nordisk we strive
to develop innovative treatments, reinforcing our long-term commitment to
defeat diabetes. Xultophy(R) is a key component of this commitment."

    About the study

    The CV risk markers data came from a new post-hoc analysis of two
Xultophy(R) randomised-controlled clinical trials, comparing the efficacy and
safety of Xultophy(R) against insulin degludec in DUAL II and against insulin
glargine U100 in DUAL V, both with metformin for 26 weeks.[4],[5] These trials
were conducted in people with type 2 diabetes not achieving glycaemic control
(HbA1c 7.5-10.0% in DUAL II; 7.0-10.0% in DUAL V) on basal insulin (20-40 units
in DUAL II; 20-50 units in DUAL V). The primary results from these trials have
been reported previously.[4],[5]

    About Xultophy(R)

    Xultophy(R) is a once-daily single injection fixed-ratio combination of
long-acting insulin degludec (Tresiba(R)) and the GLP-1 receptor agonist
liraglutide (Victoza(R)) in one pen. It is indicated for the treatment of
adults with type 2 diabetes mellitus to improve glycaemic control in
combination with oral glucose-lowering medicinal products when these alone or
combined with basal insulin do not provide adequate glycaemic control.
Xultophy(R) is given once daily by subcutaneous injection. Xultophy(R) can be
administered at any time of the day with or without meals, preferably at the
same time of the day.[6] On 18 September 2014, Xultophy(R) was granted
marketing authorisation by the European Commission. On 21 November 2016,
Xultophy(R) was approved by the FDA under the brand name Xultophy(R)
100/3.6.[6],[7]

    About Novo Nordisk

    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 41,400 people in
77 countries and markets its products in more than 165 countries. For more
information, visit http://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. Vilsboll T BT, Bode BW, et al. IDegLira improves cardiovascular risk
markers in patients with type 2 diabetes uncontrolled on basal insulin:
analyses of DUAL II and DUAL V. Abstract at the 53rd Annual Meeting of the
European Association for the Study of Diabetes (EASD), Lisbon, Portugal; 11-15
September 2017.

    2. Low Wang C, Hess C, Goldfine A. Clinical update: cardiovascular disease
in diabetes mellitus. Atherosclerotic cardiovascular disease and heart failure
in type 2 diabetes mellitus – mechanisms, managment of patients with stable
ischemic heart disease. J Am Coll Cardiol. 2016;60:e44-e164.

    3. Kurukulasuriya L, Sowers J. Therapies for type 2 diabetes: lowering
HbA1c and associated cardiovascular risk factors. Cardiovasc Diabetol.
2010;9:1-13.

    4. Buse JB, Vilsboll T, Thurman J, et al. Contribution of liraglutide in
the fixed-ratio combination of insulin degludec and liraglutide (IDegLira).
Diabetes Care. 2014:2926-2933.

    5. Lingvay I, Harris S, Jaeckel E, et al. IDegLira was effective across a
range of dysglycaemia and BMI categories in the DUAL V randomized trial.
Diabetes Obes Metab. 2017. DOI: 10.1111/dom.13043.

    6. EMA. Xultophy(R) Summary of Product Characteristics. Available at:
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002647/WC500177657.pdf
. Last accessed: September 2017.

    7. Novo Nordisk. Novo Nordisk recieves US FDA approval for Xultophy(R)
100/3.6. Available at:http://www.novonordisk.com/bin/getPDF.2058006.pdf. Last
accessed: September 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
     Christina Jensen            +45-3079-3009     cnje@novonordisk.com
     Kasper Veje (US)            +1-609-235-8567   kpvj@novonordisk.com


SOURCE:  Novo Nordisk