drugset / Trial / NCT00662857

A Study Designed to Compare 2 Dose Strengths of TI Inhalation Powder in Adults With Type 1 Diabetes Mellitus and to Compare One of Those Formulations (30Units) With an Injection of Insulin Lispro

NCT00662857

Phase 2 Completed 29 enrolled Mannkind Corporation
RandomizedCrossoverOpen-labelTreatment

Summary

28 subjects to be enrolled for a screening period, 3 dosing visits \& a follow-up visit. Visits 2 and 3 dosing of TI Inhalation Powder, cross over between two 15 U cartridges and one 30 U cartridge. Visit 4 dosing will be a sc injection of 10 IU of RAA (rapid-acting insulin analogue).

Timeline

Start
2008-04
Primary completion
2008-11
Completion
2008-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Insulin Protein / enzyme biologic 30 iu Inhaled
Subject Insulin Lispro Protein / enzyme biologic 10 iu Subcutaneous