CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 589 enrolled
Drug / intervention
Technosphere Insulin +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.

Search/NCT00308308
NCT00308308Phase 3Completed

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

Mannkind Corporation·interventional·Posted Mar 29, 2006·Updated Oct 16, 2014

In Brief

A Phase 3 clinical trial evaluating Technosphere Insulin and Active comparator for Diabetes, Type I. Completed, enrolled 589 participants across 129 sites in 10 countries.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Brazil, Canada, Chile, Mexico, Poland, Russia, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 29, 2006
Enrollment StartFeb 1, 2006
Primary CompletionJul 1, 2008
Study CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 20.3 years ago

Interventions

Technosphere Insulindrug

Inhalation, 15U/30U

Active comparatordrug

sc injectable insulin