A Clinical Trial Comparing Short-Term Efficacy and Safety of Exubera and Lantus
Information source: Pfizer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus, Type 2
Intervention: Inhaled Human Insulin (Exubera) (Drug); Insulin Glargine (Lantus) (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
To compare short-term efficacy and safety of Exubera vs Lantus in patients with type 2
diabetes mellitus
Clinical Details
Official title: 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
Study design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
Primary outcome: Variability of blood glucose over a period of 72 hours
Secondary outcome: Insulin pharmacokinetics
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Diabetes mellitus Type 2
Exclusion Criteria:
- Severe Asthma, severe COPD
- Smoking
Locations and Contacts
Pfizer Investigational Site, Chula Vista, California, United States
Additional Information
To obtain contact information for a study center near you, click here. Link to ClinicalStudyResults.org Posting:
Starting date: September 2006
Ending date: February 2007
Last updated: January 25, 2008
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