NCT00309244

Efficacy and Safety in Subjects With Type 2 Diabetes Receiving Subcutaneous Basal Insulin and Prandial Inhalation of Technosphere/Insulin Versus Subcutaneous Premixed Insulin Therapy Over a 52-Week Treatment Period and a 4-Week Follow-up

A Prospective, Multi-Center, Open-Label, Randomized, Controlled Clinical Trial Comparing the Efficacy and Safety in Subjects With Type 2 Diabetes Receiving Subcutaneous Basal Insulin and Prandial Inhalation of Technosphere /Insulin Versus Subcutaneous Premixed Insulin Therapy Over a 52-Week Treatment Period and a 4-Week Follow-up

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 677 (actual)
• Sponsor: Mannkind Corporation · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this 13 month study (12 month treatment period and 1 month follow-up period) is to determine whether inhaled insulin is safe and effective in the treatment of type 2 diabetes.

Conditions

• Diabetes Type 2

Interventions

Type	Name	Description
DRUG	Technosphere® Insulin Inhalation Powder	Inhalation, 15U/30U
DRUG	70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)	BPR 70/30, which is a premix of intermediate acting and rapid acting insulin given sc

Timeline

• Start date: 2006-02-01
• Primary completion: 2008-08-01
• Completion: 2008-09-01
• First posted: 2006-03-31
• Last updated: 2014-10-16
• Results posted: 2014-10-16

Locations

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