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

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 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
^®
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

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.