What is it?  Tresiba® (insulin degludec) is a new basal insulin for adult patients with type 1 and type 2 diabetes It is indicated for the treatment of diabetes mellitus in adults.

 

Why is it important? Insulin degludec effectively reduces blood glucose levels in patients with type 1 and 2 diabetes while significantly reducing the risk of nocturnal hypoglycaemia compared with the most commonly prescribed basal insulin in the UK. 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.

 

What does the evidence say? Studies found that there was a 25% reduction in nocturnal hypoglycaemia for patients with type 1 diabetes [4.41 vs 5.86 episodes per patient year of exposure (PYE); p=0.02].1 There was also a 36% reduction in nocturnal 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)1 or for insulin naïve patients with type 2 diabetes (1.52 vs 1.85 per patient year of exposure; p=0.11).2

 

What do people say about it? Professor Richard Holt, Professor in Diabetes and Endocrinology at the University of Southampton, said: "With our current insulin treatments, it is important for people with diabetes to take their long-acting insulin at around the same time each day. However, the pharmacokinetics of insulin degludec mean that, on occasions when this is not possible, people with diabetes can alter the time they take their insulin without compromising their diabetes control or putting themselves at increased risk of  hypoglycaemia. Good control of diabetes is essential to reduce the risk of long-term complications, so flexibility, when needed, is important."

 

Why is controlling hypoglycaemia important? Hypoglycaemic episodes are one of the most common side effects of insulin treatment, and although insulin degludec significantly reduces nocturnal hypoglycaemia, hypoglycaemia is still the most frequent side effect. Of particular concern is the risk of nocturnal hypoglycaemia; often when the patient is sleeping and therefore less aware of the onset of symptoms. 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. In 2010/11, the estimated UK cost for severe hypoglycaemia was £30.4 million and for moderate hypoglycaemia £41.8 million.3 Each severe hypoglycaemic episode involving hospitalisation, costs the NHS an estimated £2,153 per person. Almost 50% of severe hypoglycaemic episodes occur at night and the most severe night-time episodes can be fatal if left untreated. Severe episodes are estimated to be responsible for 6% of deaths in people with diabetes under the age of 40 years.

 

1.     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: 1489-97

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.            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