Support for insulin degludec use in type 1 diabetes patients prone to nocturnal hypoglycemia
medwireNews: Findings from the HypoDeg trial suggest that insulin degludec is associated with a lower risk for hypoglycemia than insulin glargine U100 among people with type 1 diabetes who are prone to nocturnal severe hypoglycemia.
As outlined at the virtual ADA 80th Scientific Sessions, the phase 4 randomized crossover study included 149 adults with at least one episode of nocturnal severe hypoglycemia – defined as hypoglycemia causing cognitive impairment that required external assistance for recovery. They were randomly assigned to receive basal–bolus therapy with either degludec or glargine U100 as their basal insulin, along with insulin aspart. Participants spent 1 year in each treatment arm, both of which comprised a 3-month run-in period (for insulin dose adjustment and stabilization of treatment) and a 9-month maintenance period.
Presenting author Rikke Agesen (Nordsjællands Hospital, Hillerød, Denmark) said that patients who were treated with insulin degludec had significantly lower rates of symptomatic nocturnal hypoglycemia during the maintenance periods than those given glargine, with a relative rate reduction of 28% for level 1 hypoglycemia (≤3.9 mmol/L; 70 mg/dL) and 37% for level 2 hypoglycemia (≤3.0 mmol/L; 54 mg/dL). Glycated hemoglobin levels were comparable in both groups throughout the study.
Rates of 24-hour severe hypoglycemia were also significantly lower in the degludec group, at an average of 0.5 events/year compared with 0.9 events/year in the glargine group, resulting in a relative rate reduction of 35%. Agesen said that the number needed to treat to avoid one episode of 24-hour severe hypoglycemia in 1 year was approximately three patients.
And she noted that the risk reduction was “mainly explained by a reduction in nocturnal severe hypoglycemia.” Severe hypoglycemia events occurred predominantly during the evening and overnight when participants were using glargine, but were more evenly distributed when they were using degludec.
The main findings of the HypoDeg trial were supported by a substudy involving 89 participants who used continuous glucose monitoring (CGM).
Julie Brøsen, also from Nordsjællands Hospital, reported that rates of CGM-measured nocturnal nonsevere, nocturnal asymptomatic, daytime nonsevere, and daytime symptomatic hypoglycemia were significantly lower among patients treated with degludec versus glargine. Rates of nocturnal symptomatic and daytime asymptomatic hypoglycemia were comparable in the two groups, however.
The investigators also found that insulin degludec significantly reduced glycemic variability as measured by CGM, both over 24 hours and overnight, but not during the daytime.
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