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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exubera (inhaled insulin) | Drug | |||
| 8-point glucose diary (to assess pre- and post prandial glucoses) | Procedure | |||
| Meal Tolerance Test | Procedure | |||
| 24-hour continuous glucose monitoring (at select sites) | Procedure | |||
| Pulmonary Function Testing | Procedure | |||
| Hypoglycemic Event Monitoring | Procedure | |||
| Laboratory Assessments | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Birmingham | Alabama | United States | |||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Nutritional Counseling and Diabetes Education | Behavioral |
| 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 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C473734 | Exubera |
| D000095583 | Continuous Glucose Monitoring |
| D012143 | Respiratory Physiological Phenomena |
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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