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Trial record 1 of 1 for:    NCT00139763
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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
Sponsor:
Collaborator:
Sanofi
Information provided by:
Pfizer

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
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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE 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  ICMJE 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  ICMJE 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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE 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  ICMJE 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