Effect on Glycemic Control of Inhaled Insulin Alone or Added to Dual Oral Therapy After Failure of Dual Oral Therapy.
Efficacy And Safety Of Exubera (Inhaled Insulin) Therapy In Subjects With Type 2 Diabetes Mellitus Not Well Controlled With Combination Oral Agents: A Three-Month, Outpatient, Parallel Comparative Trial.
1 other identifier
interventional
345
2 countries
52
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 diabetes-mellitus-type-2
Started Jun 1999
52 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 1999
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2000
CompletedFirst Submitted
Initial submission to the registry
August 29, 2006
CompletedFirst Posted
Study publicly available on registry
August 31, 2006
CompletedFebruary 13, 2007
February 1, 2007
August 29, 2006
February 9, 2007
Conditions
Outcome Measures
Primary Outcomes (2)
The primary efficacy endpoint is the change from baseline HbA1c measured at 12 weeks after randomization.
HbA1c is measured at Weeks -4, -1, 0, 6, and 12 of comparative treatment. The baseline value is the mean of the Week -1 and Week 0 values.
Secondary Outcomes (7)
Secondary: Efficacy: change in fasting plasma glucose and meal glucose response (2-h postprandial increment in plasma glucose)Fasting plasma glucose measured at Weeks -4, -1, 0, and 12 (the Weeks -1 and 12 measurements will be part of the meal studies)
Meal glucose response measured at Week -1 and at Week 12;
These results for efficacy are measured in the lab using plasma samples collected during clinic visits,
not the subject's home glucose monitoring results.
Comparison of 24-hour home glucose profiles.
- +2 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- Asthma, COPD
- Smoking during the previous 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
- Sanoficollaborator
- Nektar Therapeuticscollaborator
Study Sites (52)
Pfizer Investigational Site
Irvine, California, 92618, United States
Pfizer Investigational Site
Long Beach, California, 90806, United States
Pfizer Investigational Site
Los Angeles, California, 90059, United States
Pfizer Investigational Site
Los Angeles, California, 90073, United States
Pfizer Investigational Site
Newport Beach, California, 92663, United States
Pfizer Investigational Site
San Diego, California, 92108, United States
Pfizer Investigational Site
Tustin, California, 92780, United States
Pfizer Investigational Site
New Britain, Connecticut, 06050, United States
Pfizer Investigational Site
New Haven, Connecticut, 06510, United States
Pfizer Investigational Site
New Haven, Connecticut, 06519, United States
Pfizer Investigational Site
Washington D.C., District of Columbia, 20007, United States
Pfizer Investigational Site
Clearwater, Florida, 33761, United States
Pfizer Investigational Site
Hollywood, Florida, 33021, United States
Pfizer Investigational Site
Miami, Florida, 33136, United States
Pfizer Investigational Site
Tampa, Florida, 33607, United States
Pfizer Investigational Site
Louisville, Kentucky, 40202, United States
Pfizer Investigational Site
New Orleans, Louisiana, 70121, United States
Pfizer Investigational Site
Minneapolis, Minnesota, 55416, United States
Pfizer Investigational Site
Columbia, Missouri, 65212, United States
Pfizer Investigational Site
St Louis, Missouri, 63141, United States
Pfizer Investigational Site
Omaha, Nebraska, 68131, United States
Pfizer Investigational Site
New York, New York, 10016, United States
Pfizer Investigational Site
New York, New York, 10025, United States
Pfizer Investigational Site
Rochester, New York, 14642, United States
Pfizer Investigational Site
Greenville, North Carolina, 27858, United States
Pfizer Investigational Site
Winston-Salem, North Carolina, 27157, United States
Pfizer Investigational Site
Cleveland, Ohio, 44195, United States
Pfizer Investigational Site
Portland, Oregon, 97201-3098, United States
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19104, United States
Pfizer Investigational Site
Austin, Texas, 78758, United States
Pfizer Investigational Site
Dallas, Texas, 75230, United States
Pfizer Investigational Site
Dallas, Texas, 75235-8858, United States
Pfizer Investigational Site
Dallas, Texas, 75246, United States
Pfizer Investigational Site
Irving, Texas, 75061, United States
Pfizer Investigational Site
San Antonio, Texas, 78229, United States
Pfizer Investigational Site
Burlington, Vermont, 05401, United States
Pfizer Investigational Site
Renton, Washington, 98055, United States
Pfizer Investigational Site
Calgary, Alberta, T3B 0M3, Canada
Pfizer Investigational Site
Edmonton, Alberta, T5H 3V9, Canada
Pfizer Investigational Site
Edmonton, Alberta, T6G 2C8, Canada
Pfizer Investigational Site
Edmonton, Alberta, T6G 2S2, Canada
Pfizer Investigational Site
Red Deer, Alberta, T4N 6V7, Canada
Pfizer Investigational Site
Winnipeg, Manitoba, R3A 1R9, Canada
Pfizer Investigational Site
Winnipeg, Manitoba, R3E 3P4, Canada
Pfizer Investigational Site
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
Pfizer Investigational Site
Halifax, Nova Scotia, B3H 2Y9, Canada
Pfizer Investigational Site
Ottawa, Ontario, K1Y 4E9, Canada
Pfizer Investigational Site
Toronto, Ontario, M5B 1WB, Canada
Pfizer Investigational Site
Toronto, Ontario, M5C 2T2, Canada
Pfizer Investigational Site
Toronto, Ontario, M5G 1X5, Canada
Pfizer Investigational Site
Toronto, Ontario, M5G 2C4, Canada
Pfizer Investigational Site
Laval, Quebec, H7T 2P5, Canada
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 29, 2006
First Posted
August 31, 2006
Study Start
June 1, 1999
Study Completion
September 1, 2000
Last Updated
February 13, 2007
Record last verified: 2007-02