Last updated on May 2018

Afrezza Safety and Pharmacokinetics Study in Pediatric Patients


Brief description of study

Primary Objective:

-To assess the safety and tolerability of Afrezza in children ages 4 to 17 years with type 1 diabetes mellitus (T1DM).

Secondary Objectives:

  • To assess the ability to titrate the prandial and supplemental doses of Afrezza at each meal.
  • To assess pharmacokinetics (PK) following a prandial dose of Afrezza in children ages 4 to 17 years with T1DM.

Detailed Study Description

The patients are expected to participate in the study for approximately 6 to 8 weeks from Screening to final follow-up visit.

Clinical Study Identifier: NCT02527265

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Investigational Site 637
Aurora, CO United States
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Investigational Site 635
New Haven, CT United States
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Investigational Site 636
Gainesville, FL United States
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Investigational Site 002
Atlanta, GA United States
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Investigational Site 639
Atlanta, GA United States
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Investigational Site 642
Atlanta, GA United States
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Investigational Site 638
Baltimore, MD United States
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Investigational Site 640
Philadelphia, PA United States
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Investigational Site 641
Memphis, TN United States
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Investigational Site 643
Tampa, FL United States
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