Demonstrate Exubera Works As Well As Avandia When Added To Sulfonylurea + Metformin In Controlling Glucose

October 28, 2008 updated by: Pfizer

A One-Year, Open, Randomized, Parallel, Three-Arm Study Comparing Exubera® (Insulin Dry Powder Pulmonary Inhaler) vs. Avandia® (Rosiglitazone Maleate) as Add-On Therapy vs. Exubera® Substitution of Sulfonylurea in Patients With Type 2 Diabetes, Poorly Controlled on Combination Sulfonylurea and Metformin Treatment

  • Whether a combination of three therapies - metformin and a sulfonylurea plus Exubera, an investigational drug, controls your diabetes at least as much as a triple combination therapy of metformin and a sulfonylurea plus Avandia, a Food and Drug Administration (FDA) approved drug.
  • Whether a combination of two therapies - metformin plus Exubera controls your diabetes at least as much as a as a triple combination therapy of metformin and a sulfonylurea plus Avandia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

626

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

    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Pfizer Investigational Site
      • Wollongong, New South Wales, Australia, 2500
        • Pfizer Investigational Site
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Pfizer Investigational Site
      • Woolloongabba, Queensland, Australia, 4102
        • Pfizer Investigational Site
    • South Australia
      • Keswick, South Australia, Australia, 5035
        • Pfizer Investigational Site
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Pfizer Investigational Site
      • Caulfield, Victoria, Australia, 3162
        • Pfizer Investigational Site
    • RS
      • Porto Alegre, RS, Brazil, 90035-170
        • Pfizer Investigational Site
    • SP
      • Sao Paulo, SP, Brazil, 01244-030
        • Pfizer Investigational Site
      • Sao Paulo, SP, Brazil, 04231-030
        • Pfizer Investigational Site
      • St. John's, Canada, A1E 2E2
        • Pfizer Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 3P4
        • Pfizer Investigational Site
    • Ontario
      • London, Ontario, Canada, N6A 4V2
        • Pfizer Investigational Site
      • Mississauga, Ontario, Canada, L5M2V8
        • Pfizer Investigational Site
      • Oakville, Ontario, Canada, L6H 3P1
        • Pfizer Investigational Site
      • Thornhill, Ontario, Canada, L4J 1V8
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M4N-3M5
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M4R 2G4
        • Pfizer Investigational Site
    • Quebec
      • Laval, Quebec, Canada, H7T 2P5
        • Pfizer Investigational Site
      • Montreal, Quebec, Canada, H1T 2M4
        • Pfizer Investigational Site
      • St Jerome, Quebec, Canada, J7Z 5T3
        • Pfizer Investigational Site
      • Vaudreuil, Quebec, Canada, J7V 8P9
        • Pfizer Investigational Site
      • Mexico Df, Mexico, CP 14000
        • Pfizer Investigational Site
    • DF
      • Mexico, DF, Mexico, 02990
        • Pfizer Investigational Site
      • Mexico, DF, Mexico, 03100
        • Pfizer Investigational Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44340
        • Pfizer Investigational Site
      • Guadalajara, Jalisco, Mexico, 44349
        • Pfizer Investigational Site
      • Guadalajara, Jalisco, Mexico, 44660
        • Pfizer Investigational Site
    • Jalisco/Mexico
      • Guadalajara, Jalisco/Mexico, Mexico, 44347
        • Pfizer Investigational Site
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64060
        • Pfizer Investigational Site
    • Veracruz
      • Jalapa, Veracruz, Mexico, 91020
        • Pfizer Investigational Site
    • Arizona
      • Mesa, Arizona, United States, 85205
        • Pfizer Investigational Site
      • Phoenix, Arizona, United States, 85012
        • Pfizer Investigational Site
      • Tucson, Arizona, United States, 85715
        • Pfizer Investigational Site
    • Arkansas
      • Searcy, Arkansas, United States, 72143
        • Pfizer Investigational Site
    • California
      • Alhambra, California, United States, 91801
        • Pfizer Investigational Site
      • Concord, California, United States, 94520
        • Pfizer Investigational Site
      • Huntington Beach, California, United States, 92648
        • Pfizer Investigational Site
      • Huntington Beach, California, United States, 92647
        • Pfizer Investigational Site
      • La Jolla, California, United States, 92037
        • Pfizer Investigational Site
      • Long Beach, California, United States, 90806
        • Pfizer Investigational Site
      • Long Beach, California, United States, 90805
        • Pfizer Investigational Site
      • Los Angeles, California, United States, 90048
        • Pfizer Investigational Site
      • Riverside, California, United States, 92506
        • Pfizer Investigational Site
      • Santa Barbara, California, United States, 93105
        • Pfizer Investigational Site
      • Tustin, California, United States, 92780
        • Pfizer Investigational Site
      • Westminster, California, United States, 92683
        • Pfizer Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80209
        • Pfizer Investigational Site
      • Wheat Ridge, Colorado, United States, 80033
        • Pfizer Investigational Site
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Pfizer Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Pfizer Investigational Site
      • Washington, District of Columbia, United States, 20307
        • Pfizer Investigational Site
    • Florida
      • Hollywood, Florida, United States, 33021
        • Pfizer Investigational Site
      • West Palm Beach, Florida, United States, 33401
        • Pfizer Investigational Site
      • Winter Park, Florida, United States, 32789
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Pfizer Investigational Site
      • Augusta, Georgia, United States, 30909
        • Pfizer Investigational Site
      • Savannah, Georgia, United States, 31405
        • Pfizer Investigational Site
      • Savannah, Georgia, United States, 31419
        • Pfizer Investigational Site
    • Hawaii
      • Ewa Beach, Hawaii, United States, 96706
        • Pfizer Investigational Site
      • Honolulu, Hawaii, United States, 96813
        • Pfizer Investigational Site
    • Idaho
      • Idaho Falls, Idaho, United States, 83404-6370
        • Pfizer Investigational Site
      • Idaho Falls, Idaho, United States, 83404-7542
        • Pfizer Investigational Site
      • Idaho Falls,, Idaho, United States, 83404-7542
        • Pfizer Investigational Site
    • Illinois
      • Chicago Heights, Illinois, United States, 60411
        • Pfizer Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Pfizer Investigational Site
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • Pfizer Investigational Site
    • Kansas
      • Wichita, Kansas, United States, 67203
        • Pfizer Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Pfizer Investigational Site
      • Louisville, Kentucky, United States, 40213
        • Pfizer Investigational Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pfizer Investigational Site
      • New Orleans, Louisiana, United States, 70112
        • Pfizer Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Pfizer Investigational Site
    • Massachusetts
      • Springfield, Massachusetts, United States, 01103
        • Pfizer Investigational Site
      • Springfield, Massachusetts, United States, 01199
        • Pfizer Investigational Site
      • Waltham, Massachusetts, United States, 02453
        • Pfizer Investigational Site
    • Minnesota
      • West St. Paul, Minnesota, United States, 55118
        • Pfizer Investigational Site
    • Missouri
      • North Kansas City, Missouri, United States, 64116
        • Pfizer Investigational Site
      • St. Louis, Missouri, United States, 63141
        • Pfizer Investigational Site
    • Montana
      • Butte, Montana, United States, 59701
        • Pfizer Investigational Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68521
        • Pfizer Investigational Site
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • Pfizer Investigational Site
      • New Brunswick, New Jersey, United States, 08901
        • Pfizer Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Pfizer Investigational Site
    • New York
      • Albany, New York, United States, 12208
        • Pfizer Investigational Site
      • Flushing, New York, United States, 11365
        • Pfizer Investigational Site
      • Mineola, New York, United States, 11501
        • Pfizer Investigational Site
      • New Hyde Park, New York, United States, 11042
        • Pfizer Investigational Site
      • Rochester, New York, United States, 14642
        • Pfizer Investigational Site
    • North Carolina
      • Raleigh, North Carolina, United States, 27609
        • Pfizer Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Pfizer Investigational Site
      • Cleveland, Ohio, United States, 44195
        • Pfizer Investigational Site
      • Lakewood, Ohio, United States, 44107
        • Pfizer Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Pfizer Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97210
        • Pfizer Investigational Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15235
        • Pfizer Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Pfizer Investigational Site
      • Charleston, South Carolina, United States, 29401-5799
        • Pfizer Investigational Site
      • Duncan, South Carolina, United States, 29334
        • Pfizer Investigational Site
      • Spartanburg, South Carolina, United States, 29303
        • Pfizer Investigational Site
      • Spartanburg, South Carolina, United States, 29307
        • Pfizer Investigational Site
      • Sumter, South Carolina, United States, 29150
        • Pfizer Investigational Site
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Pfizer Investigational Site
      • Knoxville, Tennessee, United States, 37909
        • Pfizer Investigational Site
      • Memphis, Tennessee, United States, 38119
        • Pfizer Investigational Site
      • Nashville, Tennessee, United States, 37232
        • Pfizer Investigational Site
    • Texas
      • Corpus Christi, Texas, United States, 78411
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75230
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75246
        • Pfizer Investigational Site
      • El Paso, Texas, United States, 79935
        • Pfizer Investigational Site
      • El Paso, Texas, United States, 79925
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78229
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78237
        • Pfizer Investigational Site
    • Utah
      • Ogden, Utah, United States, 84403
        • Pfizer Investigational Site
    • Virginia
      • Fredericksburg, Virginia, United States, 22401
        • Pfizer Investigational Site
      • Richmond, Virginia, United States, 23294
        • Pfizer Investigational Site
      • Richmond, Virginia, United States, 23221
        • Pfizer Investigational Site
    • Washington
      • Renton, Washington, United States, 98055
        • Pfizer Investigational Site
      • Tukwila, Washington, United States, 98188
        • Pfizer Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209
        • 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:

  • Type 2 diabetes
  • Currently treated and on a stable doses of drugs for the preceding two (2) months

Exclusion Criteria:

  • Type 1 Diabetes
  • Smoking

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Glycosylated hemoglobin

Secondary Outcome Measures

Outcome Measure
Change from baseline in fasting plasma glucose. Other secondary efficacy
endpoints include, body weight, patient reported outcomes, incidence and severity
of hypoglycemic episodes, cough questionnaire, and discontinuation rate due to
insufficient clinical response.

Collaborators and Investigators

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

Sponsor

Collaborators

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.

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

January 1, 2003

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

September 6, 2005

First Submitted That Met QC Criteria

September 6, 2005

First Posted (Estimate)

September 8, 2005

Study Record Updates

Last Update Posted (Estimate)

October 31, 2008

Last Update Submitted That Met QC Criteria

October 28, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Other Study ID Numbers

  • A2171017

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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