A dose escalating open label study in Type 1 diabetic subjects, to assess the pharmacodynamics activity of transbuccal human recombinant insulin compared to subcutaneous human insulin.

Trial Profile

A dose escalating open label study in Type 1 diabetic subjects, to assess the pharmacodynamics activity of transbuccal human recombinant insulin compared to subcutaneous human insulin.

Completed
Phase of Trial: Phase II

Latest Information Update: 30 Jun 2016

At a glance

  • Drugs Insulin (Primary) ; Insulin
  • Indications Type 1 diabetes mellitus
  • Focus Pharmacodynamics
  • Acronyms MSL001-PH-2-1
  • Sponsors Midatech - MonoSol Rx (JV)
  • Most Recent Events

    • 29 Jun 2016 Status changed from recruiting to completed.
    • 04 Sep 2015 Treatment section revised to include a new formulation of transbuccal strip (Formulation B transbuccal strip ), an additional treatment visit cycle (now eight treatment visits instead of seven, clarification around the data analysis and review period.
    • 27 Jul 2015 According to a MonoSol Rx media release, status changed from not yet recruiting to recruiting.
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