At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 353 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.
A Phase 3, Multicenter, Double-blind, Placebo-controlled, Randomized, Clinical Trial Evaluating the Efficacy and Safety of Prandial Technosphere® Insulin Inhalation Powder Versus Technosphere Inhalation Powder in Insulin Naïve Subjects With Type 2 Diabetes Mellitus Poorly Controlled With Oral Antidiabetic Agents Over a 24 Week Treatment Period
In Brief
A Phase 3 clinical trial evaluating Technosphere® Insulin and Technosphere Powder for Type 2 Diabetes. Completed, enrolled 353 participants across 76 sites in 4 countries.
Detailed Summary
Insulin-naive subjects with Type 2 Diabetes Mellitus who are sub-optimally controlled on either maximum tolerated dose of metformin or maximum tolerated dose of metformin plus one or two other oral anti-diabetic medications will have either Prandial Technosphere® Insulin or Technosphere Powder (placebo) added to their oral antidiabetic drugs.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes
CountriesBrazil, Russia, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 2011
Enrollment StartNov 2011
Primary CompletionJun 2013
Study CompletionJul 2013
TodayJul 2026
First PostedOct 13, 2011
Enrollment StartNov 1, 2011
Primary CompletionJun 1, 2013
Study CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 14.7 years ago
Interventions
Technosphere® Insulindrug
Technosphere® Insulin Inhalation Powder
Technosphere Powderdrug
Placebo Comparator