NCT01445951

Clinical Trial Evaluating Technosphere® Insulin Versus Insulin Aspart in Subjects With Type 1 Diabetes Mellitus Over a 24-week Treatment Period

A Phase 3, Multicenter, Open-label, Randomized, Forced-titration Clinical Trial Evaluating the Efficacy and Safety of Technosphere® Insulin Inhalation Powder in Combination With a Basal Insulin Versus Insulin Aspart in Combination With a Basal Insulin in Subjects With Type 1 Diabetes Mellitus Over a 24-week Treatment Period

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 518 (actual)
• Sponsor: Mannkind Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Open-label, randomized, forced-titration clinical trial evaluating the efficacy and safety of TI Inhalation Power in combination with a basal insulin versus insulin aspart in combination with a basal insulin

Detailed description

Phase 3 clinical trial designed to examine the efficacy and safety of inhaled prandial TI Inhalation Power in combination with basal insulin versus insulin aspart in combination with basal insulin in subjects with type 1 diabetes who are suboptimally controlled with their current insulin regimens. This trial will employ a variety of methods to intensively manage these subjects.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Technosphere® Insulin with MedTone C Inhaler	Inhalation Powder and injectable insulin
DRUG	Technosphere ®Insulin with Gen2 Inhaler	Inhalation Powder and injectable insulin
DRUG	Insulin Aspart in combination with a basal insulin	Injectable insulin

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-05-01
• Completion: 2013-06-01
• First posted: 2011-10-04
• Last updated: 2014-10-22
• Results posted: 2014-10-22

Locations

90 sites across 4 countries: United States, Brazil, Russia, Ukraine