Insulin degludec (Tresiba) has previously been demonstrated to reduce nocturnal hypoglycaemia in people with type 1 diabetes; however, insulin trials typically exclude individuals who are at high risk of hypoglycaemia. Therefore, the present trial sought to compare insulin degludec U100 with insulin glargine U100 in individuals at high risk of severe nocturnal hypoglycaemia.
A total of 149 people with type 1 diabetes who had experienced one or more episodes of severe nocturnal hypoglycaemia were enrolled in a 2-year, crossover study with a prospective, randomised, open-label, blinded-endpoint design. They were assigned in a randomised order to receive degludec or glargine, both in a basal–bolus regimen with insulin aspart as the short-acting insulin. Both treatment arms involved a 3-month titration period followed by a 9-month maintenance period. As the participants were prone to hypoglycaemia, glycaemic targets were set to maintain the baseline level of control in both treatment arms.
The primary outcome was the number of episodes of blindly adjudicated nocturnal hypoglycaemia. Treatment with degludec reduced the relative rate of level 1 hypoglycaemia (≤3.9 mmol/L) by 28%, and level 2 hypoglycaemia (≤3.0 mmol/L) by 37%. The relative rate of severe hypoglycaemia at any time was reduced by 35%. The absolute risk of nocturnal hypoglycaemia was estimated to be reduced by 0.8 events per person-year.
These results are consistent with those observed in the clinical trials of insulin degludec. Although the open-label design is a weakness of the study, this was partially compensated for by the blinded adjudication of the results. The authors thus conclude that treatment with insulin degludec reduces the risk of nocturnal and severe hypoglycaemia in people with type 1 diabetes who are at risk of these complications.
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