Advice
following a second resubmission:
insulin degludec (Tresiba®) is accepted for use within NHS Scotland.
Indication under review: treatment of diabetes mellitus in adults.
In three phase III studies in adults with type 1 diabetes mellitus, and five phase III studies in adults with type 2 diabetes mellitus, insulin degludec was non-inferior to other long-acting insulin analogues, assessed by the mean change in glycosylated haemoglobin (HbA1c).
Insulin degludec is also indicated for the treatment of diabetes mellitus in adolescents and children from the age of 1 year. The holder of the marketing authorisation has not made a submission to SMC regarding this indication and as a result SMC cannot recommend its use within NHS Scotland.
Download detailed advice224KB (PDF)
Medicine details
- Medicine name:
- insulin degludec (Tresiba)
- SMC ID:
- 856/13
- Indication:
- Treatment of diabetes mellitus in adults.
- Pharmaceutical company
- Novo Nordisk Ltd
- BNF chapter
- Endocrine system
- Submission type
- Resubmission
- Status
- Accepted
- Date advice published
- 08 August 2016