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Open-label, single-arm, multiple-dose safety, titration, and pharmacokinetic study of AFREZZA® in pediatric subjects ages 4 to 17 years with type 1 diabetes mellitus

Investigating an Inhaled Medication for Blood Sugar Control in Youth with Type 1 Diabetes

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4-12 years
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This study investigates how an inhaled investigational medication affects blood sugar levels in children and adolescents with Type 1 diabetes. Type 1 diabetes is a condition where the body cannot produce insulin, a hormone that helps control blood sugar levels. The study aims to understand how much of the medication enters the bloodstream after a single dose and assess its safety for participants aged 4 to 17 years.

Participants will receive a single dose of the investigational medication. Researchers will monitor blood sugar levels and check for any side effects. This will help determine if the medication is effective and safe for young individuals with Type 1 diabetes.

  • Who can participate: Children and adolescents aged 4 to 17 years who have been diagnosed with Type 1 diabetes for at least 1 year and are currently on multiple daily injections can participate. Participants should have no history of asthma.
  • Study details: Participants will receive a single dose of the investigational medication, and their blood sugar levels will be monitored. The study will also assess the safety of the medication for children and adolescents.
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Study details
    type 1 diabetes mellitus

TX10301

19 February 2024

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