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INHALE-1: A 26-week Primary Treatment Phase, With 26-week Extension, Open-label, Randomized Clinical Trial Evaluating the Efficacy and Safety of Afrezza Versus Rapid-acting Insulin Analog Injections, Both in Combination With a Basal Insulin, in Pediatric Subjects With Type 1 or Type 2 Diabetes Mellitus

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Trial Profile

INHALE-1: A 26-week Primary Treatment Phase, With 26-week Extension, Open-label, Randomized Clinical Trial Evaluating the Efficacy and Safety of Afrezza Versus Rapid-acting Insulin Analog Injections, Both in Combination With a Basal Insulin, in Pediatric Subjects With Type 1 or Type 2 Diabetes Mellitus

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Oct 2025

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At a glance

  • Drugs Insulin (Primary) ; Insulin detemir (Primary) ; Insulin aspart
  • Indications Type 1 diabetes mellitus; Type 2 diabetes mellitus
  • Focus Therapeutic Use
  • Acronyms INHALE-1
  • Sponsors MannKind Corporation

Most Recent Events

  • 06 Aug 2025 According to a MannKind Corporation media release, topline results from the full pediatric study including the safety extension have been submitted for presentation at a medical meeting in 2H 2025
  • 06 Aug 2025 According to a MannKind Corporation media release, company ubmitted an sBLA for Afrezza Inhalation Powder in the pediatric population with a review acceptance decision expected in early 4Q 2025, filing is based on data from this study.
  • 22 Jun 2025 According to The American Diabetes Association media release, results from the INHALE-1 study were presented today as a symposium at the 85th Scientific Sessions of the American Diabetes Association (ADA) in Chicago.

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