US Inhaled Insulin Therapeutic Choice Questionnaire Study

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00139763
First received: August 29, 2005
Last updated: March 15, 2007
Last verified: March 2007
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, Arizona
Pfizer Investigational Site
Chandler, Arizona, United States, 85224
Pfizer Investigational Site
Mesa, Arizona, United States, 85201
Pfizer Investigational Site
Phoenix, Arizona, United States, 85051
Pfizer Investigational Site
Phoenix, Arizona, United States, 85006-2850
Pfizer Investigational Site
Tempe, Arizona, United States, 85282
United States, California
Pfizer Investigational Site
Los Angeles, California, United States, 90033
Pfizer Investigational Site
San Diego, California, United States, 92120
United States, Colorado
Pfizer Investigational Site
Colorado Springs, Colorado, United States, 80904
United States, Delaware
Pfizer Investigational Site
Newark, Delaware, United States, 19713
Pfizer Investigational Site
Wilmington, Delaware, United States, 19805
United States, District of Columbia
Pfizer Investigational Site
Washington, District of Columbia, United States, 20010-2934
United States, Florida
Pfizer Investigational Site
Jacksonville, Florida, United States, 32205
Pfizer Investigational Site
Jacksonville, Florida, United States, 32216
United States, Idaho
Pfizer Investigational Site
Hayden, Idaho, United States, 83835
Pfizer Investigational Site
Nampa, Idaho, United States, 83714
United States, Illinois
Pfizer Investigational Site
Gurnee, Illinois, United States, 60031
United States, Maryland
Pfizer Investigational Site
Elkton, Maryland, United States, 21921
United States, Michigan
Pfizer Investigational Site
Detroit, Michigan, United States, 48235
United States, Minnesota
Pfizer Investigational Site
Minneapolis, Minnesota, United States, 55416
United States, Missouri
Pfizer Investigational Site
St. Louis, Missouri, United States, 63141
United States, Nebraska
Pfizer Investigational Site
Omaha, Nebraska, United States, 68131
United States, New Jersey
Pfizer Investigational Site
Margate City, New Jersey, United States, 08402-2218
United States, New Mexico
Pfizer Investigational Site
Santa Fe, New Mexico, United States, 87505
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10016
United States, North Carolina
Pfizer Investigational Site
Morehead City, North Carolina, United States, 28557
Pfizer Investigational Site
Salisbury, North Carolina, United States, 28144
Pfizer Investigational Site
Statesville, North Carolina, United States, 28625
Pfizer Investigational Site
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45236
United States, Oregon
Pfizer Investigational Site
Portland, Oregon, United States, 97239
Pfizer Investigational Site
Portland, Oregon, United States, 97219
United States, South Carolina
Pfizer Investigational Site
Orangeburg, South Carolina, United States, 29118
Pfizer Investigational Site
Simpsonville, South Carolina, United States, 29681
United States, Texas
Pfizer Investigational Site
Arlington, Texas, United States, 76014-2010
Pfizer Investigational Site
Dallas, Texas, United States, 75231
Pfizer Investigational Site
Madisonville, Texas, United States, 77864
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
United States, Vermont
Pfizer Investigational Site
Bennington, Vermont, United States, 05201-5018
United States, Virginia
Pfizer Investigational Site
Virginia Beach, Virginia, United States, 23462
United States, Washington
Pfizer Investigational Site
Spokane, Washington, United States, 99207
Pfizer Investigational Site
Tacoma, Washington, United States, 98405
United States, Wisconsin
Pfizer Investigational Site
Milwaukee, Wisconsin, United States, 53218
Sponsors and Collaborators
Pfizer
Sanofi
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 11, 2014