At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 677 enrolled
Drug / intervention
Technosphere® Insulin Inhalation Powder +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Technosphere® Insulin Inhalation Powder and 70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin) for Diabetes Type 2. Completed, enrolled 677 participants across 151 sites in 10 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Type 2
CountriesArgentina, Brazil, Canada, Chile, Mexico, Poland, Russia, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2006
First PostedMar 2006
Primary CompletionAug 2008
Study CompletionSep 2008
TodayJul 2026
First PostedMar 31, 2006
Enrollment StartFeb 1, 2006
Primary CompletionAug 1, 2008
Study CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 20.3 years ago
Interventions
Technosphere® Insulin Inhalation Powderdrug
Inhalation, 15U/30U
70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)drug
BPR 70/30, which is a premix of intermediate acting and rapid acting insulin given sc