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.
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)
- 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.