medwireNews: Results of the Onset 1 trial confirm that treatment with fast-acting insulin aspart provides improves glycemic control compared with conventional insulin aspart (IAsp) among adults with type 1 diabetes.
David Russell-Jones (Royal Surrey County Hospital and University of Surrey, Guildford, UK) and study co-authors randomly assigned participants to receive double-blind mealtime faster aspart, double-blind IAsp, or open-label post-meal faster aspart. All insulin treatments were delivered in a basal–bolus regimen.
After 26 weeks of treatment, mean glycated hemoglobin (HbA1c) levels decreased from 8.0% to 7.3% among participants receiving mealtime faster aspart, from 8.0% to 7.4% among those in the mealtime IAsp group, and from 8.1% to 7.5% in those receiving post-meal faster aspart.
Compared with IAsp, these results translate into estimated treatment differences of –0.15% for mealtime faster aspart and 0.04% for post-meal faster aspart, demonstrating noninferiority of both faster aspart regimens to IAsp in terms of changes in HbA1c levels, explain the authors in Diabetes Care.
Although the reduction in HbA1c was significantly greater among patients treated with mealtime faster aspart compared with IAsp, the team notes that “superiority could not be considered confirmed” with the hierarchical statistical testing procedure used.
Participants receiving mealtime faster aspart were almost 1.5 times as likely to achieve a target HbA1c level below 7.0% than those receiving IAsp (33.3 vs 28.2%; odds ratio=1.47), but the odds of achieving this target were not significantly different between patients receiving post-meal aspart and IAsp (23.3 vs 28.2%; odds ratio=0.73).
The overall rate of hypoglycemic episodes was “comparable” between the two faster aspart and IAsp groups, as was the incidence of treatment-emergent adverse events, indicating that “safety profiles were similar between treatments.”
The researchers note that post-meal dosing of insulin could provide “increased flexibility compared with mealtime dosing” in certain situations, such as when people are unable to predict the carbohydrate content of a meal in advance, or if an injection is forgotten.
And they conclude: “[F]aster aspart offers the option of dosing up to 20 min postmeal while retaining overall glycemic control and without increased rates of overall hypoglycemia.
“This is an incremental step in more closely replicating the physiologic response of endogenous insulin release after a meal.”
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