Tresiba(R) (Insulin Degludec) A New Basal Insulin For Adult Patients With Type 1 And Type 2 Diabetes Is Available In The UK
Main Category: DiabetesArticle Date: 06 Mar 2013 - 2:00 PST
Tresiba(R) (Insulin Degludec) A New Basal Insulin For Adult Patients With Type 1 And Type 2 Diabetes Is Available In The UK
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Insulin degludec is indicated for the treatment of diabetes mellitus in adults[1].
Novo Nordisk UK has announced that insulin degludec (brand name Tresiba(R)), a new oncedaily 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 nighttime hypoglycaemia, compared with the most commonly prescribed basal insulin in the UK[4]:
- 25% reduction in nighttime 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 nighttime hypoglycaemia for insulin naive 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 naive patients with type 2 diabetes (1.52 vs 1.85 per patient year of exposure; p=0.11)[2]
"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 nighttime hypoglycaemia, hypoglycaemia is still the most frequent side effect[1]. However, of particular concern is the risk of nighttime 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 GBP30.4 million and for moderate hypoglycaemia GBP41.8 million[8]. Each severe hypoglycaemic episode involving hospitalisation, costs the NHS an estimated GBP2,153 per person[9],[10]. Almost 50% of severe hypoglycaemic episodes occur at night and the most severe nighttime 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(R) pens: FlexTouch(R) U100, which is suitable for doses from 1 to 80 units per injection and dials in one unit increments, and FlexTouch(R) 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.
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2) Zinman B et al., Insulin Degludec Versus Insulin Glargine in InsulinNaive Patients With Type 2 Diabetes: A 1year, randomized, treattotarget trial (BEGIN Once Long) Diabetes Care. 2012;35(12):246471.
3) Heller S et al., Insulin degludec, an ultralong acting basal insulin, versus insulin glargine in basalbolus treatment with mealtime insulin aspart in type 1 diabetes (BEGIN BasalBolus Type 1): a phase 3 randomised, openlabel, treattotarget noninferiority trial. Lancet. 2012;379:14891497.
4) Ratner RE et al., Prospectively planned metaanalysis comparing hypoglycemia rates of insulin degludec with those of insulin glargine. Diabetes, Obesity and Metabolism. 2013;15(2):175184.
5) Meneghini L et al., The Efficacy and Safety of Insulin Degludec Given in Variable OnceDaily Dosing Intervals Compared With Insulin Glargine and Insulin Degludec Dosed at the Same Time Daily: A 26week, randomized, openlabel, parallelgroup, treattotarget trial in people with type 2 diabetes. Diabetes Care. 2013 [epub ahead of print] dow: 10.2337/dc121668.
6) Leiter LA et al., Assessment of the Impact of Fear of Hypoglycemic Episodes on Glycemic and Hypoglycemia Management. Can J Diabetes. 2005;29:18692.
7) Allen KV et al., BM. Nocturnal hypoglycemia: clinical manifestations and therapeutic strategies toward prevention. Endocr Pract. 2003;9(6):53043.
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):85562.
9) ISD Scotland. Available here. Last accessed: February 2013.
10) Department of Health. Payment by results tariffs. Available here. Last accessed: February 2013.
11) Sovik O et al., Deadinbed syndrome in young diabetic patients. Diabetes Care. 1999;22(S2):B402.
12) Novo Nordisk data on file. DOFIDeg130712005.
13) NHS Choices. Diabetes introduction. Available here. Last accessed: February 2013.
14) Diabetes UK. State of the Nation 2012. Available here. Last accessed: February 2013.
15) Cefalu CA et al., Controlling hypoglycemia in type 2 diabetes: which agent for which patient? J Fam Pract. 2005;54:85562.
16) American Diabetes Association Working Group on Hypoglycemia. Defining and reporting hypoglycemia in diabetes. Diabetes Care. 2005;28:12459.
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;24:11521.
19) Brod M et al., The impact of nonsevere hypoglycemic events on work productivity and diabetes management. Value Health 2011;14:66571.
20) Donnelly LA et al., Frequency and Predictors of Hypoglycaemia in Type 1 and InsulinTreated Type 2 Diabetes: A PopulationBased Study. Diabet Med. 2005;22:74955.
Source: Novo Nordisk
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