Does Your Child Dislike Shots? Looking Into Afrezza for Children

Welcome to trial watch, where we keep an eye on the latest and greatest trials going on in the field of diabetes. Here, you can learn about new therapies and devices currently under study, and learn more about participating in these trials. Trial participants can get early access to new treatments, receive care at clinical trial centers, and are usually compensated for their time. You can read more about clinical trials at the “Center Watch” volunteer page or the ClinicalTrials.Gov information page. 

Twitter Summary: Trial assesses the safety of inhaled rapid-acting insulin Afrezza for pediatric patients – enrolling now in CO + FL.

Clinical Trial Identifier: NCT02527265

Trial name: Afrezza Safety and Pharmacokinetics Study in Pediatric Patients

Diabetes type: Type 1 diabetes

What it’s testing: This trial will assess the safety, pharmacokinetics (how a drug is metabolized by the body), and ability to titrate Afrezza (rapid-acting inhaled insulin) in children ages 4 to 17 years with type 1 diabetes.

Trial participants will initially receive a single dose at breakfast and have several blood draws for four hours to assess pharmacokinetics. They will subsequently receive an individualized dose of Afrezza at each meal (breakfast, lunch and dinner) for 30 days, with an optional extension of up to a year. All participants will receive injections of basal long acting insulin at bedtime each day.

What the trial is measuring: This safety study is focused on adverse events, hypoglycemia, and other critical safety outcomes in kids. More details here.

Why is this new/important: Afrezza was approved in 2014 in adults, and this study could help bring it to younger patients. We believe Afrezza would be particularly useful for children who are averse to needles and injections.

Trial Length: Six to eight weeks (from initial screening to the last follow-up visit), with optional extension up to a year for those who respond well to the Afrezza + basal insulin therapy.

Trial Location: The trial is currently recruiting in Aurora, Colorado and Gainesville, Florida.

Do you qualify?

• 4 - 17 years old

• Type 1 diabetes and used insulin for at least one year

• A1c of 7%-10%

• Administering insulin via multiple daily injections (MDI) for at least 6 weeks prior to study

• If on a pump, willing to convert to MDI for duration of trial participation

• Basal insulin once daily in the evening

Individuals who answer “yes” to any of the following questions are not eligible for this study:

• Do you have a body mass index (BMI) below the 25th or above the 95th percentile for age and gender according to CDC growth charts? (Calculate your BMI percentile here)

• Have you ever been diagnosed with asthma?

• Do you have an allergy or hypersensitivity to Afrezza?

For a full list of inclusion and exclusion criteria see here.

Where to get more information: For more information, please go to the trial’s webpage and view the contact information specific to each enrolling location. -CA