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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: 19 Jun 2026

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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 Jun 2026 Results presented in the MannKind Corporation media release.
  • 29 May 2026 According to a MannKind Corporation media release, the U.S. Food and Drug Administration (FDA) has approved insulin human (Afrezza) Inhalation Powder for use in children and adolescents aged 6 and older living with type 1 and type 2 diabetes, based on results from this trial.
  • 29 May 2026 According to a MannKind Corporation media release, the company will host conference call to discuss the recent FDA approval of Afrezz

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