US Inhaled Insulin Dose Titration Study
A Randomized, Open-Label, Multicenter Study Assessing the Effects of Forced Exubera Dose Titration on Glycemic Control in Patients With Suboptimally Controlled Type 2 Diabetes on Two or More Oral Antidiabetic Agents
1 other identifier
interventional
120
1 country
16
Brief Summary
This study will examine how to dose Exubera (inhaled insulin) in patients who are not well controlled on two or more diabetes pills. This study should show that a large number of patients enrolled in the study can reach the target Hemoglobin A1C levels (7% or less) that have been set by the American Diabetes Association (ADA). Target goals should be achieved by adjusting the Exubera dose either weekly or twice weekly. Patients will also receive nutritional counseling and diabetes education as part of the study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 diabetes-mellitus-type-2
Started Nov 2005
16 active sites
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
October 28, 2005
CompletedFirst Posted
Study publicly available on registry
October 31, 2005
CompletedStudy Start
First participant enrolled
November 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedFebruary 8, 2008
May 1, 2007
October 28, 2005
February 6, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of patients with type 2 diabetes (A1C 7.5-10% on >= 2 oral agents) in each study arm (Exubera dosage adjusted 'once weekly' or 'twice weekly') that attain an A1C of <=7% with forced dose titration of Exubera at 6 months.
Secondary Outcomes (1)
Secondary endpoints include change in A1C, fasting and 2 hr PP glucose, 24-hr mean glucose measured by continuous glucose monitoring, weight, lipids, and markers of oxidative stress. Hypoglycemia will also be assessed.
Interventions
Eligibility Criteria
You may qualify if:
- Male and female, age \>= 18 years and \<= 80 years, with a diagnosis of type 2 diabetes made at least 6 months prior to study entry, with hemoglobin A1C 7.5-10%
- Currently treated with 2 or more oral antidiabetic agents (sulfonylureas, metformin, and/or thiazolidinediones)
You may not qualify if:
- Type 1 diabetes
- Smoking within the past 6 months or significant pulmonary diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Pfizer Investigational Site
Birmingham, Alabama, United States
Pfizer Investigational Site
Los Angeles, California, United States
Pfizer Investigational Site
New Britain, Connecticut, United States
Pfizer Investigational Site
Norwalk, Connecticut, United States
Pfizer Investigational Site
Hollywood, Florida, United States
Pfizer Investigational Site
Atlanta, Georgia, United States
Pfizer Investigational Site
Boise, Idaho, United States
Pfizer Investigational Site
Hayden, Idaho, United States
Pfizer Investigational Site
Baton Rouge, Louisiana, United States
Pfizer Investigational Site
Boston, Massachusetts, United States
Pfizer Investigational Site
Albany, New York, United States
Pfizer Investigational Site
Syracuse, New York, United States
Pfizer Investigational Site
Dallas, Texas, United States
Pfizer Investigational Site
El Paso, Texas, United States
Pfizer Investigational Site
San Antonio, Texas, United States
Pfizer Investigational Site
Bennington, Vermont, 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 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 28, 2005
First Posted
October 31, 2005
Study Start
November 1, 2005
Study Completion
March 1, 2007
Last Updated
February 8, 2008
Record last verified: 2007-05