US Inhaled Insulin Therapeutic Choice Questionnaire Study

March 15, 2007 updated by: Pfizer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

740

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • 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
        • Pfizer Investigational Site
    • California
      • Los Angeles, California, United States, 90033
        • Pfizer Investigational Site
      • San Diego, California, United States, 92120
        • Pfizer Investigational Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80904
        • Pfizer Investigational Site
    • Delaware
      • Newark, Delaware, United States, 19713
        • Pfizer Investigational Site
      • Wilmington, Delaware, United States, 19805
        • Pfizer Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20010-2934
        • Pfizer Investigational Site
    • Florida
      • Jacksonville, Florida, United States, 32216
        • Pfizer Investigational Site
      • Jacksonville, Florida, United States, 32205
        • Pfizer Investigational Site
    • Idaho
      • Hayden, Idaho, United States, 83835
        • Pfizer Investigational Site
      • Nampa, Idaho, United States, 83714
        • Pfizer Investigational Site
    • Illinois
      • Gurnee, Illinois, United States, 60031
        • Pfizer Investigational Site
    • Maryland
      • Elkton, Maryland, United States, 21921
        • Pfizer Investigational Site
    • Michigan
      • Detroit, Michigan, United States, 48235
        • Pfizer Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55416
        • Pfizer Investigational Site
    • Missouri
      • St. Louis, Missouri, United States, 63141
        • Pfizer Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Pfizer Investigational Site
    • New Jersey
      • Margate City, New Jersey, United States, 08402-2218
        • Pfizer Investigational Site
    • New Mexico
      • Santa Fe, New Mexico, United States, 87505
        • Pfizer Investigational Site
    • New York
      • New York, New York, United States, 10016
        • Pfizer Investigational Site
    • North Carolina
      • 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
        • Pfizer Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45236
        • Pfizer Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97219
        • Pfizer Investigational Site
      • Portland, Oregon, United States, 97239
        • Pfizer Investigational Site
    • South Carolina
      • Orangeburg, South Carolina, United States, 29118
        • Pfizer Investigational Site
      • Simpsonville, South Carolina, United States, 29681
        • Pfizer Investigational Site
    • Texas
      • 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
        • Pfizer Investigational Site
    • Vermont
      • Bennington, Vermont, United States, 05201-5018
        • Pfizer Investigational Site
    • Virginia
      • Virginia Beach, Virginia, United States, 23462
        • Pfizer Investigational Site
    • Washington
      • Spokane, Washington, United States, 99207
        • Pfizer Investigational Site
      • Tacoma, Washington, United States, 98405
        • Pfizer Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53218
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Educational/Counseling/Training
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Collaborators

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Study Completion

March 1, 2006

Study Registration Dates

First Submitted

August 29, 2005

First Submitted That Met QC Criteria

August 30, 2005

First Posted (Estimate)

August 31, 2005

Study Record Updates

Last Update Posted (Estimate)

March 19, 2007

Last Update Submitted That Met QC Criteria

March 15, 2007

Last Verified

March 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A2171066

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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