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A Prospective, Multi-Center, Open-Label, Randomized, Controlled Clinical Trial Comparing the Efficacy and Safety in Subjects With Type 2 Diabetes Receiving Subcutaneous Basal Insulin and Prandial Inhalation of Technosphere /Insulin Versus Subcutaneous Premixed Insulin Therapy Over a 52-Week Treatment Period and a 4-Week Follow-up

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A Prospective, Multi-Center, Open-Label, Randomized, Controlled Clinical Trial Comparing the Efficacy and Safety in Subjects With Type 2 Diabetes Receiving Subcutaneous Basal Insulin and Prandial Inhalation of Technosphere /Insulin Versus Subcutaneous Premixed Insulin Therapy Over a 52-Week Treatment Period and a 4-Week Follow-up

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 03 Aug 2022

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At a glance

  • Drugs Insulin (Primary) ; Insulin aspart/insulin protamine aspart; Insulin glargine
  • Indications Type 2 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Sponsors MannKind Corporation

    • Most Recent Events

    • 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
    • 26 Jun 2010 Results were published in the Lancet.

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