Tresiba (insulin degludec)
Tresiba (insulin degludec) is a long-acting insulin analogue with slow and continuous delivery after subcutaneous injections. The indication is treatment of diabetes mellitus in adults. Dosing should be adjusted to meet individual patient needs. In type 1 diabetes, Tresiba must be combined with short-/rapid-acting insulin to cover mealtime insulin requirements.
Compared to the insulin analogues glargin and detemir no clinically relevant difference in the effect on HbA1c after 26 or 52 weeks of treatment has been found. However, the glucose lowering effect is maintained for a longer period of time with degludec and the day-to-day variation is less compared to glargin.
The most frequent adverse events are nasopharyngitis, head ache and diarrhea. There is no unambiguous evidence showing that the risk of hypoglycaemia is reduced with degludec compared to glargin. The risk appears to be dependt on diabetes type and at which time the patient is sampled during the treatment course. So far the European and the American regulatory authorities have not agreed on the assessment of the cardiovascular risk profile.
It is IRF’s overall assessment that the clinical advantages using degludec instead of NPH-insulin, glargin, or detemir are not well enough demonstrated to compensate for the significantly more expensive cost of treatment. Tresiba should therefore only be considered if the patient does not reach treatment goal with NPH insulin as a first choice or subsequently with glargin or detemir.
Tresiba was marketed March 4th 2013. It is currently possible to apply for single reimbursement.