At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 261 enrolled
Drug / intervention
Insulin Glargine (Lantus®) +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 Six Month, Open-Label Outpatient, 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 (Lantus®) and Inhaled Human Insulin (Exubera®) for Diabetes Mellitus, Type 2. Completed, enrolled 261 participants across 62 sites in 10 countries.
Detailed Summary
To compare efficacy and safety of Exubera® vs Lantus® in patients with type 2 diabetes mellitus.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesBelgium, Finland, France, Germany, Netherlands, Norway, Poland, Spain, Sweden, Switzerland
Collaborators--
Timeline
Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 2006
Enrollment StartDec 2006
Primary CompletionAug 2008
TodayJul 2026
First PostedOct 23, 2006
Enrollment StartDec 1, 2006
Primary CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 19.7 years ago
Interventions
Insulin Glargine (Lantus®)drug
Patient will be randomized to Lantus® while remaining on pre-study oral hypoglycemic agents.
Inhaled Human Insulin (Exubera®)drug
Patient will be randomized inhaled insulin while remaining on pre-study oral hypoglycemic agents.