Status:
COMPLETED
Effect on Glycemic Control of Inhaled Insulin Alone or Added to Dual Oral Therapy After Failure of Dual Oral Therapy.
Lead Sponsor:
Pfizer
Collaborating Sponsors:
Sanofi
Nektar Therapeutics
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
35-80 years
Phase:
PHASE3
Brief Summary
To assess the impact on glucose control by inhaled insulin alone or added to two oral anti-diabetic agents in patients with type 2 diabetes who are not well controlled on 2 oral anti-diabetic agents.
Eligibility Criteria
Inclusion
- Type 2 Diabetes Mellitus as defined by American Diabetes Association (ADA) at least 1 year earlier.
- Patients were required to have been treated with a stable oral agent regimen involving 2 antidiabetc medications: 1 insulin secretagogue (a sulfonylurea or replabinide) and 1 insulin sensitizer (a thiazolidinedione or metformin).
Exclusion
- Asthma, COPD
- Smoking during the previous 6 months
Key Trial Info
Start Date :
June 1 1999
Trial Type :
INTERVENTIONAL
End Date :
September 1 2000
Estimated Enrollment :
345 Patients enrolled
Trial Details
Trial ID
NCT00370565
Start Date
June 1 1999
End Date
September 1 2000
Last Update
February 13 2007
Active Locations (52)
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1
Pfizer Investigational Site
Irvine, California, United States, 92618
2
Pfizer Investigational Site
Long Beach, California, United States, 90806
3
Pfizer Investigational Site
Los Angeles, California, United States, 90059
4
Pfizer Investigational Site
Los Angeles, California, United States, 90073