A review of the latest data presented at the 16th Annual Diabetes Technology Meeting in Bethesda, US.
Results from a study comparing the pharmacodynamics of insulin degludec (Tresiba) with insulin glargine U300 in people with type 1 diabetes were presented at the 16th Annual Diabetes Technology Meeting in Bethesda, US. Treatment with insulin degludec (0.4 U/kg) resulted in lower day-to-day and within-day variability in glucose-lowering effect, compared with insulin glargine U300 (0.4 U/kg).
The study showed that the day-to-day variability was approximately four times lower with insulin degludec than with insulin glargine U300. Within-day variability was approximately 40% lower with insulin degludec, with the glucose-lowering effect being more evenly distributed across 24 hours compared to insulin glargine U300. In addition, insulin glargine U300 showed a 30% lower potency assessed by the total glucose-lowering effect compared to insulin degludec.
Dr Tim Heise, lead scientist at the Profil Institute in Germany, said: “While large-scale head-to-head trials are needed to compare the efficacy and safety of new insulins, pharmacodynamic studies are important, as they enable us to better understand their pharmacological properties. The more stable the glucose lowering profile of insulin, the easier it is to titrate and can help reduce the risk of hypoglycaemia and hyperglycaemia in patients with diabetes.”
This was a phase 1, single-centre, double-blind, two-period, cross-over trial, where people with type 1 diabetes were randomly assigned to receive insulin degludec or insulin glargine U300 at a dose of 0.4 U/kg/day. A total of 57 people completed the study. Both treatments were administered once daily for 12 days, followed by a 7–21 day period in which the participants received no study treatment, before being crossed over to receive the other treatment for a further 12 days. In order to assess the pharmacodynamic variability in the glucose-lowering effect of insulin degludec and insulin glargine U300, each participant underwent six 24-hour glucose clamps (three during each 12-day study period) performed at steady state (where glucose levels are stabilised in the participants).
Insulin degludec is a once-daily basal insulin that provides a duration of action beyond 42 hours. It has been approved in more than 80 countries globally. It was most recently approved by the FDA in the United States on 26 September 2015.