NCT00308308

Efficacy & Safety of Inhaled Insulin in Type 1 Diabetes

A Prospective, Multi-Center, Open-Label, Randomized, Controlled Clinical Trial Comparing the Efficacy and Safety in Subjects With Type 1 Diabetes Receiving Subcutaneous Basal Insulin and Prandial Inhalation of Technosphere/Insulin Versus Subcutaneous Basal and Prandial Insulin Over a 52-Week Treatment Period and a 4-Week Follow Up

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 589 (actual)
• Sponsor: Mannkind Corporation · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

To determine the safety and efficacy of inhaled insulin in the treatment of type 1 diabetes

Conditions

• Diabetes, Type I

Interventions

Type	Name	Description
DRUG	Technosphere Insulin	Inhalation, 15U/30U
DRUG	Active comparator	sc injectable insulin

Timeline

• Start date: 2006-02-01
• Primary completion: 2008-07-01
• Completion: 2008-08-01
• First posted: 2006-03-29
• Last updated: 2014-10-16
• Results posted: 2014-10-16

Locations

129 sites across 10 countries: United States, Argentina, Brazil, Canada, Chile, Mexico, Poland, Russia, Spain, United Kingdom