At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 518 enrolled
Drug / intervention
Technosphere® Insulin with MedTone C Inhaler +2 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 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
In Brief
A Phase 3 clinical trial evaluating Technosphere® Insulin with MedTone C Inhaler, Technosphere ®Insulin with Gen2 Inhaler, and 1 other intervention for Type 1 Diabetes Mellitus. Completed, enrolled 518 participants across 90 sites in 4 countries.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes Mellitus
CountriesBrazil, Russia, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2011
First PostedOct 2011
Primary CompletionMay 2013
Study CompletionJun 2013
TodayJul 2026
First PostedOct 4, 2011
Enrollment StartSep 1, 2011
Primary CompletionMay 1, 2013
Study CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 14.7 years ago
Interventions
Technosphere® Insulin with MedTone C Inhalerdrug
Inhalation Powder and injectable insulin
Technosphere ®Insulin with Gen2 Inhalerdrug
Inhalation Powder and injectable insulin
Insulin Aspart in combination with a basal insulindrug
Injectable insulin