Diabetes Mellitus, Type 2 Clinical Trial
Official title:
A US Randomized Questionnaire-Based Trial Assessing The Impact Of The Availability Of Inhaled Insulin On Therapeutic Choice In Patients With Suboptimally Controlled Type 2 Diabetes
| Verified date | March 2007 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
This is a questionnaire based study (no study drug is involved) that asks if more patients
with uncontrolled type 2 diabetes on diabetes pills will choose insulin as the next
treatment choice if inhaled insulin were available in addition to all currently available
treatments, compared with if inhaled insulin was not available as part of currently
available treatments.
This study will also ask if patients with uncontrolled type 2 diabetes currently managed on
diabetes pills + once daily insulin will choose as the next treatment choice to take insulin
multiple times a day if inhaled insulin were available in addition to all currently
available treatments, compared with if inhaled insulin was not available as part of
currently available treatments.
| Status | Completed |
| Enrollment | 740 |
| Est. completion date | March 2006 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
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 - Currently treated with either: - 2 or more oral antidiabetic agents, OR 1 or more oral antidiabetic agents and insulin glargine Exclusion Criteria: - Type 1 diabetes - Smoking within the past 6 months |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training
| Country | Name | City | State |
|---|---|---|---|
| United States | Pfizer Investigational Site | Arlington | Texas |
| United States | Pfizer Investigational Site | Bennington | Vermont |
| United States | Pfizer Investigational Site | Chandler | Arizona |
| United States | Pfizer Investigational Site | Cincinnati | Ohio |
| United States | Pfizer Investigational Site | Colorado Springs | Colorado |
| United States | Pfizer Investigational Site | Dallas | Texas |
| United States | Pfizer Investigational Site | Detroit | Michigan |
| United States | Pfizer Investigational Site | Elkton | Maryland |
| United States | Pfizer Investigational Site | Gurnee | Illinois |
| United States | Pfizer Investigational Site | Hayden | Idaho |
| United States | Pfizer Investigational Site | Jacksonville | Florida |
| United States | Pfizer Investigational Site | Jacksonville | Florida |
| United States | Pfizer Investigational Site | Los Angeles | California |
| United States | Pfizer Investigational Site | Madisonville | Texas |
| United States | Pfizer Investigational Site | Margate City | New Jersey |
| United States | Pfizer Investigational Site | Mesa | Arizona |
| United States | Pfizer Investigational Site | Milwaukee | Wisconsin |
| United States | Pfizer Investigational Site | Minneapolis | Minnesota |
| United States | Pfizer Investigational Site | Morehead City | North Carolina |
| United States | Pfizer Investigational Site | Nampa | Idaho |
| United States | Pfizer Investigational Site | New York | New York |
| United States | Pfizer Investigational Site | Newark | Delaware |
| United States | Pfizer Investigational Site | Omaha | Nebraska |
| United States | Pfizer Investigational Site | Orangeburg | South Carolina |
| United States | Pfizer Investigational Site | Phoenix | Arizona |
| United States | Pfizer Investigational Site | Phoenix | Arizona |
| United States | Pfizer Investigational Site | Portland | Oregon |
| United States | Pfizer Investigational Site | Portland | Oregon |
| United States | Pfizer Investigational Site | Salisbury | North Carolina |
| United States | Pfizer Investigational Site | San Antonio | Texas |
| United States | Pfizer Investigational Site | San Diego | California |
| United States | Pfizer Investigational Site | Santa Fe | New Mexico |
| United States | Pfizer Investigational Site | Simpsonville | South Carolina |
| United States | Pfizer Investigational Site | Spokane | Washington |
| United States | Pfizer Investigational Site | St. Louis | Missouri |
| United States | Pfizer Investigational Site | Statesville | North Carolina |
| United States | Pfizer Investigational Site | Tacoma | Washington |
| United States | Pfizer Investigational Site | Tempe | Arizona |
| United States | Pfizer Investigational Site | Virginia Beach | Virginia |
| United States | Pfizer Investigational Site | Washington | District of Columbia |
| United States | Pfizer Investigational Site | Wilmington | Delaware |
| United States | Pfizer Investigational Site | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer | Sanofi |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Will availability of inhaled insulin result in more type 2 diabetes patients choosing a treatment that involves insulin (if now on >2 OAs) or a more intensive insulin regimen (if now on OAs + glargine) compared to only standard therapies available | |||
| Secondary | Determine both patient and MD reasons for treatment choices made. Determine if treatment choice is influenced by physician specialty or patient ethnicity. Determine how cost impacts patient treatment choice. |
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