LISBON, Portugal, September 13, 2017 /PRNewswire/
Oral Presentation 113
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.
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® 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®.
"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. Therefore, treatments for type 2 diabetes should not only lower blood sugar levels but also decrease CV risk.
"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., 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.,
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. 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.,
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, Twitter, LinkedIn, YouTube.
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 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, 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.
Peter Hugreffe Ankersen
Kasper Veje (US)