News Release Archive

New insulin on the market – Insulin Degludec (Tresiba)

NICE issues Evidence Summaries for Type 1 diabetes and Type 2 diabetes

NICE Evidence Summary
NICE Evidence summaries are not NICE Guidance but provide summaries of key evidence for selected new medicines that are considered to be of significance to the NHS to provide useful information for those working in the NHS when a new medicine becomes available.

NICE has now issued evidence summaries for the new insulin degludec [Tresiba] for Type 1 and Type 2 diabetes in adults over 18 years. Insulin degludec [Tresba] is a long-acting insulin analogue available in 2 strengths: 100units/ml and 200 units/ml. It is a once daily injection with a minimum of 8 hours between injections. It is more expensive than all other long-acting insulins – 5×3 ml cartridges and 5×3 ml pre-filled pen [both 100 units/ml] are £72.00 and 3×3 ml pre-filled pen [200 units/ml] is £86.40.  NICE recommends that the cost should be taken into account when prescribing decisions are made.

Type 1 diabetes: Insulin degludec [Tresiba]
The NICE guidance for Type 1 diabetes [Clinical guideline 15] recommends that basal insulin supply for adults should be NPH (isophane) insulin or a long-acting insulin analogue when nocturnal hypoglycaemia or morning hyperglycaemia is a problem on NPH (isophane) insulin or rapid-acting insulin analogues are used for mealtime blood glucose control.

Key points from the Evidence Summary

  • Insulin degludec is non-inferior to insulin glargine in terms of glycaemic control in Type 1 diabetes.
  • There are statistically significantly lower rates of nocturnal hypoglycaemia – 1.4 and 4 episodes per patient per year with insulin degludec compared with Lantus. However, the trials failed to find a difference in the rates of overall, daytime or severe hypoglycaemia.
  • Although there is one published 104 week study reporting some safety data, there are no published studies comparing insulin degludec with NPH (isophane) insulin and none that measure patient-oriented efficacy outcomes.
  • Insulin degludec reduced HbA1cs by between 0.1% points [1 mmol/mol] and 0.4% points [4 mmol/mol] in 2 studies up to 104 weeks long. These reductions were non-inferior to Lantus.

The full Evidence Summary can be found by visiting:
http://publications.nice.org.uk/esnm24-type-1-diabetes-insulin-degludec-esnm24

Type 2 diabetes: Insulin degludec [Tresiba]
The NICE guidance on the treatment of Type 2 diabetes [Clinical guideline 87] recommends that the long-acting insulin analogues, Lantus and Levemir, can be considered in some limited circumstances, for example in people who need assistance from a carer or healthcare professional to inject their insulin, or in people whose live are restricted by recurrent symptomatic hypoglycaemia. Tresiba will be included in the updated guidance. NICE also says that the high cost of insulin degludec needs to be taken into account.
Key points from the Evidence Summary

  • It is non-inferior to insulin glargine [Lantus] in terms of glycaemic control.
  • It reduced HbA1cs by about 1.1% [12mmol/mol] over 12 months.
  • There are statistically significant lower rates of some, but not all, measures of hypoglycaemia, particularly night hypos. [Between 0.02 and 2.5 episodes per patient per year]
  • There are no published studies with a year’s information comparing insulin degludec with NPH (isophane) insulin and none that measure patient-oriented efficacy outcomes.

The full Evidence Summary can be found by visiting:
http://publications.nice.org.uk/esnm25-type-2-diabetes-insulin-degludec-esnm25

Safety for both Type 1 and Type 2 diabetes
The MHRA has issued advice to minimise the risk of medication errors associated with the higher strength, 200 units/ml formulation. The dose-counter window of the pen device shows the number of units, irrespective of strength, therefore, no dose conversion is needed.