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US Inhaled Insulin Therapeutic Choice Questionnaire Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00139763
First Posted: August 31, 2005
Last Update Posted: March 19, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sanofi
Information provided by:
Pfizer
August 29, 2005
August 31, 2005
March 19, 2007
July 2005
Not Provided
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
  • 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
Complete list of historical versions of study NCT00139763 on ClinicalTrials.gov Archive Site
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.
  • - 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
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US Inhaled Insulin Therapeutic Choice Questionnaire Study
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

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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Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Educational/Counseling/Training
Diabetes Mellitus, Type 2
Procedure: Educational Materials
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
740
March 2006
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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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00139763
A2171066
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Pfizer
Sanofi
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP