US Inhaled Insulin Dose Titration Study
Phase 3
Completed
- Conditions
- Diabetes Mellitus, Type 2
- Registration Number
- NCT00246623
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
- 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)
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Exclusion Criteria
- Type 1 diabetes
- Smoking within the past 6 months or significant pulmonary diseases
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Bennington, Vermont, United States