A Phase 3, Multicenter, Open-label, Randomized, Forced-titration Clinical Trial Evaluating the Efficacy and Safety of Technosphere(R) Insulin Inhalation Powder in Combination With a Basal Insulin Versus Insulin Aspart in Combination With a Basal Insulin in Subjects With Type 1 Diabetes Mellitus Over a 24-week Treatment Period.

Trial Profile

A Phase 3, Multicenter, Open-label, Randomized, Forced-titration Clinical Trial Evaluating the Efficacy and Safety of Technosphere(R) Insulin Inhalation Powder in Combination With a Basal Insulin Versus Insulin Aspart in Combination With a Basal Insulin in Subjects With Type 1 Diabetes Mellitus Over a 24-week Treatment Period.

Completed
Phase of Trial: Phase III

Latest Information Update: 14 Jun 2016

At a glance

  • Drugs Insulin (Primary) ; Insulin aspart
  • Indications Type 1 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Acronyms Affinity-1
  • Sponsors MannKind Corporation
  • Most Recent Events

    • 07 Jun 2017 Biomarkers information updated
    • 14 Aug 2013 Preliminary results published in a MannKind Corporation media release.
    • 14 Aug 2013 The positive results of this study and Study 175 will form the basis of an amendment to an NDA for AFREZZA, which MannKind expects to submit to the US FDA in Q4 2013, according to a media release.
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