NCT01544881

Comparison of Technosphere Insulin Inhalation Powder & Subcutaneous Rapid-Acting Analog in Subjects With Type 1 Diabetes

A Phase 1, Single-center, Open-label, Randomized, Crossover Design Clinical Study in Subjects With Type 1 Diabetes Comparing Insulin Exposure & Response Following Inhalation of Technosphere Insulin Inhalation Powder Using the Gen2C Inhaler Vs Subcutaneous Rapid-Acting Analog

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Mannkind Corporation · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This is an Open-label, randomized study in Type 1 diabetics looking at exposure and response (PK/PD) of TI using GEN2C Inhaler versus rapid acting analog.

Detailed description

Subjects with Type 1 diabetes will be randomized to either one dose of TI inhaled using the Gen2C device, or one dose of subcutaneously injected Rapid Acting Analog (RAA) and crossed over. Crossover Sequences: Sequence #1: Period 1 - one 20 U cartridge of TI; Period 2 - 8 U of RAA Sequence #2: Period 1 - 8 U RAA; Period 2 - one 20 U cartridge of TI An euglycemic clamp procedure will be performed at each dosing visit. The purpose of this study is to characterize the pharmacokinetics (PK) of the one dose of TI Inhalation Powder using the Gen2C inhaler as compared to one dose of subcutaneous RAA.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Technosphere Insulin Inhalation Powder	Inhalation Powder using the Gen2C inhaler
DRUG	Rapid Acting Analog	Subcutaneous Injection

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-09-01
• Completion: 2013-01-01
• First posted: 2012-03-06
• Last updated: 2013-01-25

Locations

1 site across 1 country: United States