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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: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 23 Dec 2024

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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

    • 16 Dec 2024 Results published in the MannKind Corporation media release Media Release.
    • 16 Dec 2024 According to a MannKind Corporation media release, company expects to submit a request for a supplemental new drug application (sNDA) meeting with the U.S. Food and Drug Administration (FDA) in 1H 2025 to discuss the data and filing timeline.
    • 07 Nov 2024 According to a MannKind Corporation media release, the company expect to announce topline data from the Phase-3 INHALE-1 pediatric study by year-end.

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