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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.

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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.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Nov 2021

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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

    • 25 Sep 2020 Results of analysis from four clinical studies: MKC-T1-009, MKC-TI101, MKC-TI171, STAT trials assessing dose titration and clinical effects of inhaled technosphere insulin compared to mealtime subcutaneous analogue insulin therapy in type 1 diabetes presented at the 56th Annual Meeting of the European Association for the Study of Diabetes
    • 25 Sep 2020 Results of a pooled analysis of data pooled from 5 trials (NCT00700622, NCT01445951, NCT00539890, NCT00308308, NCT00309244), assessing the magnitude of weight change of technosphere insulin versus comparators across the pivotal phase three program in type 1 and type 2 diabetes mellitus, presented at the 56th Annual Meeting of the European Association for the Study of Diabetes
    • 27 Jul 2020 Results (n=5505) of pooled analysis from 13 clinical studies: MKC-TI-009, MKC-TI-030, MKC-TI-101, MKC-TI-117, MKC-TI-171, MKC-TI-005, MKC-TI-014, MKC-TI-026, MKC-TI-102, MKC-TI-103, PDC-INS-0008, MKC-TI-175 and MKC-TI-162 assessing incidences of respiratory treatment-emergent adverse events, changes in pulmonary function and lung malignancies published in the Clinical Drug Investigation

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