US Inhaled Insulin Therapeutic Choice Questionnaire Study

Tracking Information
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; (submitted: October 5, 2005)	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; (submitted: August 30, 2005)	Type 2 diabetic patients suboptimally controlled on >= 2 oral agents.; - Determine whether the availability of inhaled insulin will result in more patients willing to choose a treatment option that involves insulin compared to patients for whom only the s
Change History	Complete list of historical versions of study NCT00139763 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: October 5, 2005)	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; (submitted: August 30, 2005)	- Determine influences on treatment choice based on physician specialty, patient demographics, patient diabetes history, and/or patient metabolic control; - Determine the patient's and physician's reason why the choice of therapy was made; - Determine if t
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.
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
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.
Recruitment Information
Recruitment Status ICMJE	Completed
Enrollment ICMJE; (submitted: August 30, 2005)	740
Original Enrollment ICMJE	Same as current
Study Completion Date	March 2006
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
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	Study Director: Pfizer CT.gov Call Center Pfizer
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