At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Open-Label, Randomized, 2-Way Crossover, Clinical Trial to Compare the Pharmacokinetics of 2 Formulations of "Intended Commercial Product" Technosphere® Insulin Inhalation Powder and to Determine the Bioavailability of a 30 Unit Cartridge of "Intended Commercial Product" Technosphere® Insulin Inhalation Powder Versus a 10 Unit Subcutaneous Injection of Insulin Lispro in Subjects With Type 1 Diabetes Mellitus
In Brief
A Phase 2 clinical trial evaluating Technosphere® Insulin Inhalation Powder, Technosphere Insulin® Inhalation Powder, and 1 other intervention for Diabetes Mellitus: Type 1. Completed, enrolled 29 participants across 2 sites.
Detailed 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).
Study Details
Timeline
Interventions
TI Inhalation Powder, two 15 U cartridges
TI Inhalation Powder, one 30 U cartridge
RAA Population: All subjects received a single 10 IU sc injection of insulin lispro.