At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 413 enrolled
Drug / intervention
Insulin glargine +1 moredrug
Likely dose
Insulin glargine 10 unitsfrom 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 Six Month, Open Label, Randomized Parallel Group Trial Assessing The Impact Of Dry Powder Inhaled Insulin (Exubera) On Glycemic Control Compared To Insulin Glargine (Lantus) In Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled On A Combination Of Two Or More Oral Agents
In Brief
A Phase 4 clinical trial evaluating Insulin glargine and Inhaled Insulin (Exubera) for Diabetes Mellitus, Type 2. Completed, enrolled 413 participants across 73 sites in 2 countries.
Detailed Summary
This study is to determine if inhaled insulin is effective in treating type 2 diabetes mellitus.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesPuerto Rico, United States
Collaborators--
Timeline
Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 2007
Enrollment StartMar 2007
Primary CompletionAug 2008
TodayJul 2026
First PostedJan 5, 2007
Enrollment StartMar 1, 2007
Primary CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 19.5 years ago
Interventions
Insulin glarginedrug
Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
Inhaled Insulin (Exubera)drug
Initiation dose of one mg per meal, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.