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A phase 3, 24-week, multi-center, open-label, randomized, controlled trial comparing the efficacy and safety of prandial inhalation of technosphere/insulin in combination with metformin or technosphere/insulin alone versus 2 oral anti-diabetic agents (metformin and a secretagogue) in subjects with type 2 diabetes mellitus sub-optimally controlled on combination metformin and a secretagogue

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Trial Profile

A phase 3, 24-week, multi-center, open-label, randomized, controlled trial comparing the efficacy and safety of prandial inhalation of technosphere/insulin in combination with metformin or technosphere/insulin alone versus 2 oral anti-diabetic agents (metformin and a secretagogue) in subjects with type 2 diabetes mellitus sub-optimally controlled on combination metformin and a secretagogue

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 03 Aug 2022

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At a glance

  • Drugs Insulin (Primary) ; Antihyperglycaemics; Metformin
  • Indications Type 2 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • 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
    • 28 Jul 2008 Status changed from in progress to completed as reported by ClinicalTrials.gov.
    • 03 Aug 2007 Status changed from recruiting to in progress
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