US Inhaled Insulin Therapeutic Choice Questionnaire Study - Full Text View

Sponsors and Collaborators:	Pfizer Sanofi-Aventis
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00139763

Purpose

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.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Procedure: Educational Materials	Phase III

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Educational/Counseling/Training, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Pfizer:

Primary Outcome Measures:

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 Outcome Measures:

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.

Estimated Enrollment:	740
Study Start Date:	July 2005
Estimated Study Completion Date:	March 2006

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00139763

Show 42 Study Locations

Sponsors and Collaborators

Pfizer

Sanofi-Aventis

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org Posting: This link exits the ClinicalTrials.gov site

Study ID Numbers:	A2171066
Study First Received:	August 29, 2005
Last Updated:	March 15, 2007
ClinicalTrials.gov Identifier:	NCT00139763
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

ClinicalTrials.gov processed this record on January 16, 2009