US Inhaled Insulin Therapeutic Choice Questionnaire Study
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ClinicalTrials.gov Identifier: NCT00139763 |
Recruitment Status
:
Completed
First Posted
: August 31, 2005
Last Update Posted
: March 19, 2007
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Tracking Information | ||||
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First Submitted Date ICMJE | August 29, 2005 | |||
First Posted Date ICMJE | August 31, 2005 | |||
Last Update Posted Date | March 19, 2007 | |||
Study Start Date ICMJE | July 2005 | |||
Primary Completion Date | Not Provided | |||
Current Primary Outcome Measures ICMJE |
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 | |||
Original Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT00139763 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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. | |||
Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | US Inhaled Insulin Therapeutic Choice Questionnaire Study | |||
Official Title ICMJE | 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 | |||
Brief Summary | 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. |
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Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Educational/Counseling/Training |
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Condition ICMJE | Diabetes Mellitus, Type 2 | |||
Intervention ICMJE | Procedure: Educational Materials | |||
Study Arms | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE |
740 | |||
Original Enrollment ICMJE | Same as current | |||
Study Completion Date | March 2006 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 80 Years (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00139763 | |||
Other Study ID Numbers ICMJE | A2171066 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Sanofi | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | March 2007 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |