Afrezza is already approved for use in adults. The trial is open to pediatric patients ages 4 to 18 who meet the clinical trial’s criteria.
Afrezza inhaled insulin, currently approved for adults, is being tested for children in a clinical trial at Wendy Novak Diabetes Institute, a part of Norton Children’s Endocrinology, affiliated with the UofL School of Medicine.
Norton Children’s is one of 40 sites nationally participating in the Phase 3 trial. Afrezza is an ultra-fast-acting inhaled mealtime insulin, meaning children don’t need to plan injections ahead of eating.
“One significant benefit for kids is fewer injections,” said Kupper A. Wintergerst, M.D., the local principal investigator in the study.
Dr. Wintergerst is executive director of Wendy Novak Diabetes Institute and chief of pediatric endocrinology with Norton Children’s Endocrinology.
“Multiple daily injections can be a major burden for children living with diabetes,” he said. “This formulation is a great alternative to help reduce that.”
Afrezza consists of an insulin inhalation powder in a cartridge and the inhaler. After the patient inhales the powder, it dissolves in the alveoli and is then absorbed across the alveolar walls. The Food and Drug Administration approved Afrezza for adults in 2014.
Because the Afrezza insulin is inhaled, it reaches the bloodstream much faster. Instead of taking insulin in advance of eating, which is the case with traditional, injected insulin, this formulation allows children to take the insulin even as they’re eating.
When someone with diabetes eats, the blood sugar levels begin increasing the moment the first bite of food is in the mouth. Injectable insulin is not fast enough to prevent this and must “catch up” to level off blood sugar, according to Dr. Wintergerst. With this new, ultra-fast insulin, the blood sugar rise with food can be met much faster.
MannKind Corp., which makes Afrezza, says the inhaled insulin reaches the bloodstream within a minute. According to the company, Afrezza can be inhaled at the beginning of a meal and starts lowering blood sugar levels within 12 minutes.
Other potential benefits of the Afrezza cartridge include improved compliance and a reduced incidence of hypoglycemia, or low blood sugar, compared with rapid-acting insulin analogs (RAAs) injected subcutaneously.
The open-label, 26-week INHALE-1 trial is enrolling children with Type 1 diabetes mellitus or Type 2 diabetes mellitus between the ages of 4 and 18.
The study requires each patient to have hemoglobin A1C (HbA1c) between 7.0% and 11% and an average prandial (meal) dose of insulin equal to or greater than two units per meal.
Children and adolescents are excluded if they have a recent history of blood transfusions, asthma or serious complications with diabetes.
Half of the study participants will receive Afrezza in combination with a basal insulin. The other half will be in the rapid-acting insulin analog injection group and receive insulin aspart, insulin lispro or insulin glulisine, a synthetic version of human insulin, in combination with a basal insulin.
The study’s primary measures are HbA1c at 26 weeks and the change in HbA1c from baseline to week 26.
Following week 26, all subjects will enter a treatment extension where they will receive Afrezza until week 52. The purpose of the additional 26 weeks is to assess safety and efficacy with continued use of Afrezza.
Norton Children’s Endocrinology has pediatric patients currently enrolled in the Afrezza trial, one of more than 10 clinical trials underway at Wendy Novak Diabetes Institute. Norton Children’s Hospital is ranked among the top pediatric endocrinology programs nationally by U.S. News & World Report.