medwireNews: Ultra-rapid lispro gives equivalent overall glycemic control to standard lispro, and is significantly better for some postprandial measurements in children with type 1 diabetes, shows the PRONTO-Peds trial.
Moreover, glucose control was not significantly compromised if ultra-rapid lispro was given up to 20 minutes after the start of a meal, R Paul Wadwa (University of Colorado Anschutz Medical Campus, Aurora, USA) reported at the 82nd ADA Scientific Sessions, held in New Orleans, Louisiana.
After a 4-week run-in, the 716 children with type 1 diabetes in the study were randomly assigned to use either mealtime (0–2 minutes before eating) standard or ultra-rapid lispro, or to use ultra-rapid lispro postmeal (<20 minutes after the start of the meal).
The trial participants were an average age of 12.3 years, 51% were male, and their average glycated hemoglobin (HbA1c) was 7.9% (63 mmol/mol).
After 26 weeks of follow-up, the average HbA1c was 7.85% and 7.86% for mealtime and postmeal ultra-rapid lispro, respectively, and 7.88% for standard lispro. There were no significant differences between the groups, and ultra-rapid lispro, regardless of dose timing, met the criterion for noninferiority to lispro.
In addition, 7-point blood glucose profiles at week 26 revealed significantly lower glucose levels 1 hour after the morning and evening meals for mealtime ultra-rapid lispro versus lispro.
And ultra-rapid lispro given at mealtime resulted in significantly lower postprandial glucose excursions after all three meals compared with lispro, as well as lower daily average postprandial glucose versus both lispro and ultra-rapid lispro given postmeal.
However, over the whole study period, mealtime ultra-rapid lispro was associated with a significantly increased rate of hypoglycemia (<54 mg/dL, 3.0 mmol/L) within 2 hours after the dose relative to lispro, at 6.0 versus 4.5 events per person–year. And postmeal ultra-rapid lispro was associated with a significant increase relative to lispro within 4 hours after the dose, at 13.1 versus 9.8 events per person–year.
Adverse events were generally as expected and similar between the groups, with the exception of more injection site reactions in the mealtime ultra-rapid lispro group (7.9 vs 2.7–2.9%).
Asked about this, Wadwa attributed it to ingredients in the ultra-rapid formulation designed “to increase vascular permeability and vascular dilation, so you would expect that may lead to redness at the injection site.”
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