Results from a study comparing the pharmacodynamics of Tresiba (insulin degludec) with insulin glargine U300 in people with type 1 diabetes revealed that Tresiba results 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 Tresiba than with insulin glargine U300. Within-day variability was approximately 40% lower with Tresiba, 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 Tresiba.
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.”
The results were taken from the NN1250-4227 study, a phase 1, single-centre, double-blind, two-period, cross-over trial where people with type 1 diabetes were randomly assigned to receive Tresiba or insulin glargine U300 at a dose of 0.4 U/kg/day. In all, 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 Tresiba 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).
The results were presented at the 16th Annual Diabetes Technology Meeting in Bethesda, US.