At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 547 enrolled
Drug / intervention
Technosphere Insulin +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, 24-Week, Multi-Center, Open-Label, Randomized, Controlled Trial Comparing the Efficacy and Safety of Prandial Inhalation of Technosphere/Insulin in Combination With Metformin or Technosphere/Insulin Alone Versus 2 Oral Anti-Diabetic Agents (Metformin and a Secretagogue) in Subjects With Type 2 Diabetes Mellitus Sub-optimally Controlled on Combination Metformin and a Secretagogue.
In Brief
A Phase 3 clinical trial evaluating Technosphere Insulin, Metformin & Secretagogues, and 1 other intervention for Diabetes Mellitus, Type 2. Completed, enrolled 547 participants across 120 sites in 11 countries.
Detailed Summary
to demonstrate the efficacy of inhaled Technosphere/Insulin in combination with metformin versus combination metformin and a secretagogue
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesArgentina, Brazil, Canada, Chile, Czechia, Mexico, Poland, Russia, Spain, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2004
First PostedJun 2006
Primary CompletionMar 2008
TodayJul 2026
First PostedJun 1, 2006
Enrollment StartDec 1, 2004
Primary CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 20.1 years ago
Interventions
Technosphere Insulindrug
Inhalation, 15U/30U, prandial
Metformin & Secretagoguesdrug
Metformin tablets,Secretagogues supplied as any of the currently marketed brands and formulations.
Technosphere Insulin & Metformindrug
Technosphere Insulin Inhalation Powder 15U/30U, Metformin tablets