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A Phase 3, Multicenter, Double-blind, Placebo-controlled, Randomized, Clinical Trial Evaluating the Efficacy and Safety of Prandial Technosphere Insulin Inhalation Powder Versus Technosphere Inhalation Powder in Insulin Naïve Subjects With Type 2 Diabetes Mellitus Poorly Controlled With Oral Antidiabetic Agents Over a 24 Week Treatment Period

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Trial Profile

A Phase 3, Multicenter, Double-blind, Placebo-controlled, Randomized, Clinical Trial Evaluating the Efficacy and Safety of Prandial Technosphere Insulin Inhalation Powder Versus Technosphere Inhalation Powder in Insulin Naïve Subjects With Type 2 Diabetes Mellitus Poorly Controlled With Oral Antidiabetic Agents Over a 24 Week Treatment Period

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 31 Jul 2020

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At a glance

  • Drugs Insulin (Primary)
  • Indications Type 2 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Acronyms Affinity-2
  • Sponsors MannKind Corporation
  • Most Recent Events

    • 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
    • 07 Aug 2015 Results published in the Diabetes Care.
    • 14 Aug 2013 The positive results of this study and Study 171 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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