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A Randomized, Controlled, 6-treatment, 6-sequence, 6-period Cross-over Dose Response Study of 3 Single Doses of Afrezza Inhaled Technosphere Insulin and of 3 Single Doses of SC Insulin Lispro in Patients With Diabetes Mellitus Type 1 Using the Euglycemic Clamp Technique

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Trial Profile

A Randomized, Controlled, 6-treatment, 6-sequence, 6-period Cross-over Dose Response Study of 3 Single Doses of Afrezza Inhaled Technosphere Insulin and of 3 Single Doses of SC Insulin Lispro in Patients With Diabetes Mellitus Type 1 Using the Euglycemic Clamp Technique

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 19 Nov 2021

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At a glance

  • Drugs Insulin (Primary) ; Insulin lispro
  • Indications Type 1 diabetes mellitus
  • Focus Pharmacodynamics
  • Sponsors MannKind Corporation; Sanofi

Most Recent Events

  • 13 Nov 2021 Results assessing PK/PD parameters based on administered doses of TI and LIS and compared to address concerns behind post-marketing requirement published in the Clinical Pharmacokinetics
  • 02 Oct 2017 According to a Mannkind Corporation media release, the U.S. Food & Drug Administration (FDA) has approved an update to the Afrezza prescribing information to include data from this trial.
  • 12 Jun 2016 Results were presented at the American Diabetes Association's 76th Scientific Sessions (ADA) 2016, according to a Mannkind Corporation media release.

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