Inhaled Insulin for Children With Diabetes
By Eugenia Yun
A U.S. clinical trial is recruiting children between the ages of 4 and 17 with type 1 or type 2 diabetes whose families are interested in having their children try Afrezza, an inhaled insulin. The study will evaluate the effectiveness and safety of the long-term use of this inhaled insulin in children compared with injected insulin.
Clinical Trials Identifier: NCT04974528
Trial Name: Afrezza® INHALE-1 Study in Pediatrics (INHALE-1)
Diabetes Type: Children with type 1 or type 2 diabetes
Trial Sponsor: Mannkind Corporation
What is the trial testing?
INHALE-1 is a 52-week trial evaluating the effectiveness and safety of Afrezza, an inhaled insulin, with an estimated enrollment of 264 children. For the first 26 weeks, half of the children will be given Afrezza with a basal insulin and the other half will receive rapid acting insulin (insulin aspart, insulin lispro, or insulin glulisine) with a basal insulin. After the first 26 weeks, all children in the trial will receive Afrezza for another 26 weeks to evaluate its safety and efficacy after long-term use.
The primary goal of this study is to compare the change in A1C between the two groups and determine if the inhaled insulin is at least as effective as injected insulin. The secondary goal is to learn whether the inhaled insulin is actually superior to injected insulin by evaluating rates of hypoglycemia and change in percent time in range.
Why is this trial new and important?
Afrezza is currently the only inhaled insulin available in the United States, and it is only approved for use in adults. The results of a previous phase 2 clinical trial assessing the drug’s pharmacokinetics (how a drug moves into, through, and out of the body) and safety found that this rapid acting insulin is safe in children with type 1 diabetes, ages 8 to 17 years. This phase 3 trial will provide information about how Afrezza compares to standard rapid-acting insulins that are given by injection, as well as its safety after a longer period of use.
Because insulin injections are a challenge for many people with diabetes, especially for children and their parents, a safe and effective inhaled insulin would be a helpful option for families who wish to lessen the number of injections per day needed for their child (basal insulin injections will still be necessary).
Trial Length: 52 weeks
Trial Locations: This is a multicenter, national study with 30 locations across the United States. Click here to see a list of all participating locations.
Are you interested?
Your child may be eligible to participate in this trial if that child:
Has type 1 diabetes and has been using insulin for at least 6 months, or has type 2 diabetes and has been using insulin for at least 3 months
Has received multiple daily injections of basal insulin for at least 2 weeks
Is 4 to 17 years old
Has an A1C between 7% and 11%
See a full list of inclusion/exclusion criteria here.
For more information: Please contact Johanna Ulloa of Mannkind Corporation at (818) 661-5000 or [email protected].