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Press Release

Xultophy® reduces cardiovascular risk factors in people with type 2 diabetes

Novo Nordisk A/S
Posted on: 13 Sep 17

Lisbon, Portugal, 13 September 2017 - In people with type 2 diabetes, Xultophy ® (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 53 rd Annual Meeting of the European Association for the Study of Diabetes (EASD 2017), people treated with Xultophy ® 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 ® 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 ® . 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 Vilsbøll, 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 ® ."

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 ® is certainly great news for the population at risk of developing cardiovascular disease on topof 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 developinnovative treatments, reinforcing our long-term commitment to defeat diabetes. Xultophy ® 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 ® randomised-controlled clinical trials, comparing the efficacy and safety of Xultophy ® 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 diabetesnot achieving glycaemic control  (HbA 1c 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 ®
Xultophy ® is a once-daily single injection fixed-ratio combination of long-acting insulin degludec (Tresiba ® ) and the GLP-1 receptor agonist liraglutide (Victoza ® ) 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 ® is given once daily by subcutaneous injection. Xultophy ® 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 ® was granted marketing authorisation by the European Commission. On 21 November 2016, Xultophy ® was approved by the FDA under the brand name Xultophy ® 100/3.6. 6,7

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
Christina Jensen+45 3079 3009 cnje@novonordisk.com
Anders Mikkelsen+45 3079 4461 armk@novonordisk.com
Kasper Veje (US)+1 609 235 8567 kpvj@novonordisk.com

References

  1. Vilsbøll 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 53 rd 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, Vilsbøll 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 ® 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 ® 100/3.6. Available at:  http://www.novonordisk.com/bin/getPDF.2058006.pdf . Last accessed: September 2017.
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Source: Novo Nordisk A/S via GlobeNewswire
HUG#2133765
GlobeNewswire
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Last updated on: 14/09/2017

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