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A phase 2 randomized, open label, multi-center study of the use of prandial inhaled technosphere insulin [insulin] in combination with basal subcutaneous lantus as basal insulin [insulin glargine] versus prandial subcutaneous novorapid [insulin aspart] in combination with basal subcutaneous lantus insulin in subjects with type 1 diabetes mellitus.

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A phase 2 randomized, open label, multi-center study of the use of prandial inhaled technosphere insulin [insulin] in combination with basal subcutaneous lantus as basal insulin [insulin glargine] versus prandial subcutaneous novorapid [insulin aspart] in combination with basal subcutaneous lantus insulin in subjects with type 1 diabetes mellitus.

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 04 Nov 2020

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At a glance

  • Drugs Insulin (Primary) ; Insulin aspart; Insulin glargine
  • Indications Type 1 diabetes mellitus
  • Focus Therapeutic Use

    • 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
    • 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
    • 16 Oct 2007 New trial record.

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