A Clinical Trial Comparing Short-Term Efficacy and Safety of Exubera and Lantus
A 1 Month, Open-Label Inpatient, Randomized Cross-Over Trial Assessing The Impact Of Dry Powder Inhaled Insulin (Exubera) On 24-Hour Glycemic Control Compared To Insulin Glargine (Lantus) In Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled On A Combination Of Two Oral Agents
1 other identifier
interventional
30
1 country
1
Brief Summary
To compare short-term efficacy and safety of Exubera vs Lantus in patients with type 2 diabetes mellitus
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 diabetes-mellitus-type-2
Started Sep 2006
Shorter than P25 for phase_4 diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2006
CompletedFirst Posted
Study publicly available on registry
August 22, 2006
CompletedStudy Start
First participant enrolled
September 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2007
CompletedJanuary 29, 2008
January 1, 2008
August 21, 2006
January 25, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
Variability of blood glucose over a period of 72 hours
Secondary Outcomes (1)
Insulin pharmacokinetics
Interventions
Eligibility Criteria
You may qualify if:
- Diabetes mellitus Type 2
You may not qualify if:
- Severe Asthma, severe COPD
- Smoking
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
Chula Vista, California, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 21, 2006
First Posted
August 22, 2006
Study Start
September 1, 2006
Study Completion
February 1, 2007
Last Updated
January 29, 2008
Record last verified: 2008-01