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A Phase 3b, Multicenter, Open-label, Randomized, Forced-titration Clinical Trial Evaluating the Efficacy and Safety of Technosphere Insulin Inhalation Powder, Using the Gen2 Inhaler, in Combination With Insulin Glargine Versus Insulin Aspart in Combination With Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Over a 16-week Treatment Period

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Trial Profile

A Phase 3b, Multicenter, Open-label, Randomized, Forced-titration Clinical Trial Evaluating the Efficacy and Safety of Technosphere Insulin Inhalation Powder, Using the Gen2 Inhaler, in Combination With Insulin Glargine Versus Insulin Aspart in Combination With Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Over a 16-week Treatment Period

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 08 Nov 2021

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At a glance

  • Drugs Insulin (Primary) ; Insulin aspart; Insulin glargine
  • Indications Type 2 diabetes mellitus
  • Focus 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
  • 11 May 2012 Status changed from active, no longer recruiting to discontinued as reported by ClinicalTrials.gov.
  • 06 May 2011 Planned End Date changed from 1 Jun 2011 to 1 Jan 2012 as reported by ClinicalTrials.gov.

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