CRAWLEY, UK, March 4, 2013 /PRNewswire/ --

Insulin degludec is indicated for the treatment of diabetes mellitus in adults^[1].

Novo Nordisk UK has announced that insulin degludec (brand name Tresiba^®), a new once-daily basal insulin for adult patients with type 1 and type 2 diabetes, is available in the UK as a new treatment option.

Insulin degludec effectively reduces blood glucose levels in patients with type 1 and 2 diabetes^[2],[3] while significantly reducing the risk of night-time hypoglycaemia, compared with the most commonly prescribed basal insulin in the UK^[4]:

• 25% reduction in night-time hypoglycaemia for patients with type 1 diabetes [4.41 vs 5.86 episodes per patient year of exposure (PYE); p=0.02]^[3]
• 36% reduction in night-time hypoglycaemia for insulin naïve patients with type 2 diabetes [0.25 vs 0.39 episodes per PYE; p<0.04]^[2]
• There was no significant difference in the rate of confirmed overall hypoglycaemic episodes for insulin degludec versus insulin glargine in patients with type 1 diabetes (42.54 vs 40.18 episodes per patient year of exposure p=0.48)^[3] or for insulin naïve patients with type 2 diabetes (1.52 vs 1.85 per patient year of exposure; p=0.11)^[2]

Insulin degludec is a once-daily basal insulin which can be administered at any time of the day, however preferably at the same time every day. It is the first insulin to offer people with diabetes the flexibility in the timing of insulin administration on occasions when administration at the same time of day is not possible. A minimum of eight hours between injections should always be ensured^[1],^[5].

"Many of my patients tell me when I see them in clinic that they have difficulty taking their insulin at exactly the same time each day. This is often for reasons which we can all sympathise with and understand. For example picking children up from school or working irregular shifts at work. It is thus very useful that there is now an insulin which, because of its longer duration of action, is able to offer patients a bit more flexibility in terms of timing of their dose without compromising either their glycaemic control or risk of hypoglycaemia", commented Professor Melanie J Davies, Professor of Diabetes Medicine, University of Leicester and Honorary Consultant, University Hospitals of Leicester.

Hypoglycaemic episodes are one of the most common side effects of insulin treatment^[6], and although insulin degludec significantly reduces night-time hypoglycaemia, hypoglycaemia is still the most frequent side effect^[1]. However, of particular concern is the risk of night-time hypoglycaemia; often when the patient is sleeping and therefore less aware of the onset of symptoms^[7].

While reduced risk of hypoglycaemia has obvious benefits for the person with diabetes, it is also important for society in general. The economic impact of hypoglycaemia in the UK is particularly significant^[8]. In 2010/11, the estimated UK cost for severe hypoglycaemia was £30.4 million and for moderate hypoglycaemia £41.8 million^[8]. Each severe hypoglycaemic episode involving hospitalisation, costs the NHS an estimated £2,153 per person^[9],[10]. Almost 50% of severe hypoglycaemic episodes occur at night and the most severe night-time episodes can be fatal if left untreated^[7]. Severe episodes are estimated to be responsible for 6% of deaths in people with diabetes under the age of 40^[7],[11].

Insulin degludec is available in two FlexTouch^® pens: FlexTouch^® U100, which is suitable for doses from 1 to 80 units per injection and dials in one unit increments, and FlexTouch^® U200, which allows up to 160 units of insulin in one injection and dials in two unit increments. The U200 is the first prefilled pen that allows patients who need more than 80 units of basal insulin each day to inject only once.  

"Novo Nordisk has a long heritage in changing the diabetes landscape with 90 years of innovation and leadership in diabetes care. Our focus is in developing treatments that address key challenges faced by patients and clinicians," said Peter Meeus, UK/IRE Managing Director, Novo Nordisk.

- ENDS -

Notes to Editors

About Tresiba^® (insulin degludec)

Insulin degludec is a new once-daily basal insulin for adults with diabetes, discovered and developed by Novo Nordisk. Insulin degludec reduces blood glucose levels with a lower risk of night-time hypoglycaemia compared to insulin glargine^[1]. Furthermore, insulin degludec provides a duration of action beyond 42 hours^[1], allowing for flexibility in day-to-day dosing time when needed (minimum of 8 hours between injections)^[1]. Insulin degludec is available in FlexTouch^®, Novo Nordisk's latest prefilled insulin pen, and is offered in two concentrations enabling maximum doses of up to 80 and 160 units per single injection. Insulin degludec is also available in a cartridge (Tresiba^® Penfill^®), designed to be used with Novo Nordisk insulin delivery systems.

Insulin degludec was approved for use in type 1 and type 2 diabetes on 21 January 2013 by the European Commission.

Indication: Insulin degludec is indicated for the treatment of diabetes mellitus in adults^[1].

Safety: The most frequent side effects are hypoglycaemia and injection site reactions^[1]. Hypoglycaemia is the most frequently reported adverse reaction during treatment (very common, ≥1/10)^[1]. Injection site reactions are usually mild and transitory and normally disappear during continued use (common, ≥1/100 to <1/10)^[1]. Insulin degludec has been studied in a clinical trial programme involving more than 7,000 people with diabetes^[12].

See the Summary of Product Characteristics (SmPC) for further information.

About diabetes

Diabetes (or diabetes mellitus) is a serious and challenging health condition that develops when there is too much sugar in the blood due to the body being unable to produce or respond to the hormone, insulin, in the normal way^[13]. Every three minutes, one person in the UK is diagnosed with diabetes^[14], and approximately 2.9 million people have already been diagnosed with diabetes in the UK. This figure is projected to rise to 5 million by 2025^[14].

About hypoglycaemia

Hypoglycaemia is an episode of low blood sugar which may lead to accidents, injuries and even death in severe cases^[15],[16]. It is estimated that 6% of diabetes-related deaths are linked to severe hypoglycaemic episodes^[17]. Despite advances in insulin therapy, the risk of hypoglycaemia remains a serious problem. Severe hypoglycaemic episodes (where assistance from another person is required and may result in hospitalisation) can lead to seizures, coma and even death if left untreated^[18]. Even non-severe hypoglycaemic episodes have a large impact on daily life for many people with diabetes, including lost productivity at work^[19]. People with type 1 diabetes suffer, on average, over three episodes per month (42.9 episodes per year). People with type 2 diabetes suffer, on average, over one episode per month (16.4 episodes per year)^[20]. These episodes cause many people with diabetes and their relatives to live with the fear of the next episode every day^[6].

About Novo Nordisk

Headquartered in Denmark, Novo Nordisk is a global healthcare company with 90 years of innovation and leadership in diabetes care. The company also has leading positions within haemophilia care, growth hormone therapy and hormone replacement therapy. For more information, visit novonordisk.co.uk.

® Tresiba^®, FlexTouch^®, Penfill^® and the APIS bull are trademarks owned by Novo Nordisk A/S.

References

1. Tresiba^® summary of product characteristics 2013.
2. Zinman B et al., Insulin Degludec Versus Insulin Glargine in Insulin-Naive Patients With Type 2 Diabetes: A 1-year, randomized, treat-to-target trial (BEGIN Once Long) Diabetes Care. 2012;35(12):2464-71.
3. Heller S et al., Insulin degludec, an ultra-long acting basal insulin, versus insulin glargine in basal-bolus treatment with mealtime insulin aspart in type 1 diabetes (BEGIN Basal-Bolus Type 1): a phase 3 randomised, open-label, treat-to-target non-inferiority trial. Lancet. 2012;379:1489-1497.
4. Ratner RE et al., Prospectively planned meta-analysis comparing hypoglycemia rates of insulin degludec with those of insulin glargine. Diabetes, Obesity and Metabolism. 2013;15(2):175-184.
5. Meneghini L et al., The Efficacy and Safety of Insulin Degludec Given in Variable Once-Daily Dosing Intervals Compared With Insulin Glargine and Insulin Degludec Dosed at the Same Time Daily: A 26-week, randomized, open-label, parallel-group, treat-to-target trial in people with type 2 diabetes. Diabetes Care. 2013 [epub ahead of print] dow: 10.2337/dc12-1668.
6. Leiter LA et al., Assessment of the Impact of Fear of Hypoglycemic Episodes on Glycemic and Hypoglycemia Management. Can J Diabetes. 2005;29:186-92.
7. Allen KV et al.,  BM. Nocturnal hypoglycemia: clinical manifestations and therapeutic strategies toward prevention. Endocr Pract. 2003;9(6):530-43.
8. Hex N et al., Estimating the current and future costs of Type 1 and Type 2 diabetes in the UK, including direct health costs and indirect societal and productivity costs. Diabet Med. 2012;29(7):855-62.
9. ISD Scotland. Available at URL: http://www.isdscotland.org/Health-Topics/Finance/Publications/2011-11-29/Costs_R910_2011.xls Last accessed: February 2013.
10. Department of Health. Payment by results tariffs. Available at URL: http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_124356 Last accessed: February 2013.
11. Sovik O et al., Dead-in-bed syndrome in young diabetic patients. Diabetes Care. 1999;22(S2):B40-2.
12. Novo Nordisk data on file. DOF-IDeg-130712-005.
13. NHS Choices. Diabetes introduction.  Available at URL: http://www.nhs.uk/Conditions/Diabetes/Pages/Introduction.aspx Last accessed: February 2013.
14. Diabetes UK. State of the Nation 2012. Available at URL: http://www.diabetes.org.uk/Documents/Reports/State-of-the-Nation-2012.pdf Last accessed: February 2013.
15. Cefalu CA et al., Controlling hypoglycemia in type 2 diabetes: which agent for which patient? J Fam Pract. 2005;54:855-62.
16. American Diabetes Association Working Group on Hypoglycemia. Defining and reporting hypoglycemia in diabetes. Diabetes Care. 2005;28:1245-9.
17. Bonds DE et al., The association between symptomatic, severe hypoglycaemia and mortality in type 2 diabetes: retrospective epidemiological analysis of the ACCORD study. BMJ. 2010;340:B4909.
18. Briscoe VJ et al., Hypoglycemia in type 1 and type 2 diabetes: physiology, pathophysiology and management. Clin Diabetes. 2006;24:115-21.
19. Brod M et al., The impact of non-severe hypoglycemic events on work productivity and diabetes management. Value Health 2011;14:665-71.
20. Donnelly LA et al., Frequency and Predictors of Hypoglycaemia in Type 1 and Insulin-Treated Type 2 Diabetes: A Population-Based Study. Diabet Med. 2005;22:749-55.

SOURCE Novo Nordisk