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

Recruiting
4 years - 12 years
All
1 Location

Brief description of study.

The purpose of this research study is to measure how much of the study drug (Afrezza) gets into your blood
after a single dose and measure how well it works to control your blood sugar level. We also want to make sure
this study drug is safe for children and adolescents between 4 and 17 years old.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: type 1 diabetes mellitus
  • Age: 4 years - 12 years
  • Gender: All

Inclusion Criteria

Diagnosed with Type 1 diabetes for at least 1 year

Currently on multiple daily injections

No history of asthma

Updated on 19 Feb 2024. Study ID: 1810897000

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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