A Clinical Trial Assessing the Impact of the Availability of Inhaled Insulin on Glucose Control

April 16, 2008 updated by: Pfizer

A One Year, Open-Label Outpatient, Parallel Group Trial Assessing the Impact of the Availability of Inhaled Insulin (Exubera) on Glycemic Control in Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled on a Minimum of Two Oral Anti Diabetic Agents

To assess the impact on glucose control by inhaled insulin in patients with type 2 diabetes who are not well controlled on 2 or more oral anti-diabetic agents

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

1100

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

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2L 1K8
        • Pfizer Investigational Site
      • Edmonton, Alberta, Canada, T5J 3N4
        • Pfizer Investigational Site
      • Red Deer, Alberta, Canada, T4N 6V7
        • Pfizer Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 3P4
        • Pfizer Investigational Site
    • Ontario
      • Corunna, Ontario, Canada, N0N 1G0
        • Pfizer Investigational Site
      • Oakville, Ontario, Canada, L6H 3P1
        • Pfizer Investigational Site
      • Smith Falls, Ontario, Canada, K7A 4W8
        • Pfizer Investigational Site
    • Prince Edward Island
      • Charlottetown, Prince Edward Island, Canada, C1A 5Y9
        • Pfizer Investigational Site
    • Quebec
      • Laval, Quebec, Canada, H7T 2P5
        • Pfizer Investigational Site
      • Montreal, Quebec, Canada, H3A 1A1
        • Pfizer Investigational Site
  • France
      • Bethune CEDEX, France, 62408
        • Pfizer Investigational Site
      • Bourg En Bresse, France, 01012
        • Pfizer Investigational Site
      • Bron, France, 69500
        • Pfizer Investigational Site
      • Corbeil Essonnes Cedex, France, 91106
        • Pfizer Investigational Site
      • La Rochelle Cedex, France, 17019
        • Pfizer Investigational Site
      • Montpellier CEDEX, France, F-34295
        • Pfizer Investigational Site
      • Nantes, France, 44000
        • Pfizer Investigational Site
      • Roubaix, France, 59100
        • Pfizer Investigational Site
      • TOURS cedex 7, France, 37044
        • Pfizer Investigational Site
  • Germany
      • Altenburg, Germany, 04600
        • Pfizer Investigational Site
      • Aschaffenburg, Germany, 63739
        • Pfizer Investigational Site
      • Bad Oeynhausen/ Volmerdingen, Germany, 32549
        • Pfizer Investigational Site
      • Bad-Mergentheim, Germany, 97980
        • Pfizer Investigational Site
      • Berlin, Germany, 10115
        • Pfizer Investigational Site
      • Berlin, Germany, 12687
        • Pfizer Investigational Site
      • Berlin, Germany, 14057
        • Pfizer Investigational Site
      • Delmenhorst, Germany, 27753
        • Pfizer Investigational Site
      • Dresden, Germany, 01219
        • Pfizer Investigational Site
      • Ebersdorf, Germany, 96237
        • Pfizer Investigational Site
      • Eisenach, Germany, 99817
        • Pfizer Investigational Site
      • Falkensee, Germany, 14612
        • Pfizer Investigational Site
      • Furth im Wald, Germany, 93437
        • Pfizer Investigational Site
      • Hamburg, Germany, 21073
        • Pfizer Investigational Site
      • Hamburg, Germany, 22391
        • Pfizer Investigational Site
      • Hassloch, Germany, 67454
        • Pfizer Investigational Site
      • Kuenzing, Germany, 94550
        • Pfizer Investigational Site
      • Leipzig, Germany, 04103
        • Pfizer Investigational Site
      • Meissen, Germany, 01662
        • Pfizer Investigational Site
      • Mittweida, Germany, 09648
        • Pfizer Investigational Site
      • Muenster, Germany, 48145
        • Pfizer Investigational Site
      • Muenster, Germany, 48153
        • Pfizer Investigational Site
      • Offenbach, Germany, 63065
        • Pfizer Investigational Site
      • Offenburg, Germany, 77654
        • Pfizer Investigational Site
      • Oschatz, Germany, 04758
        • Pfizer Investigational Site
      • Pirna, Germany, 01796
        • Pfizer Investigational Site
      • Riedlhuette, Germany, 94566
        • Pfizer Investigational Site
      • Riesa, Germany, 01587
        • Pfizer Investigational Site
      • Rossach, Germany, 96269
        • Pfizer Investigational Site
      • Schwabenheim, Germany, 55270
        • Pfizer Investigational Site
      • St.Ingbert, Germany, 66386
        • Pfizer Investigational Site
      • Surwold, Germany, 26903
        • Pfizer Investigational Site
      • Wangen, Germany, 88239
        • Pfizer Investigational Site
      • Wangen / Allgaeu, Germany, 88239
        • Pfizer Investigational Site
      • Witten, Germany, 58455
        • Pfizer Investigational Site
  • Italy
      • Bari, Italy, 70124
        • Pfizer Investigational Site
      • Catania, Italy, 95122
        • Pfizer Investigational Site
      • Firenze, Italy, 50134
        • Pfizer Investigational Site
      • Genova, Italy, 16132
        • Pfizer Investigational Site
      • Milano, Italy, 20132
        • Pfizer Investigational Site
      • Napoli, Italy, 80131
        • Pfizer Investigational Site
      • Padova, Italy, 35128
        • Pfizer Investigational Site
      • Palermo, Italy, 90127
        • Pfizer Investigational Site
      • Pescara, Italy, 65100
        • Pfizer Investigational Site
      • Pisa, Italy, 56124
        • Pfizer Investigational Site
      • Roma, Italy, 00133
        • Pfizer Investigational Site
      • Torino, Italy, 10126
        • Pfizer Investigational Site
      • Udine, Italy, 33100
        • Pfizer Investigational Site
      • Verona, Italy, 37126
        • Pfizer Investigational Site
  • Spain
      • Barcelona, Spain, 08036
        • Pfizer Investigational Site
      • Barcelona, Spain, 08003
        • Pfizer Investigational Site
      • Barcelona, Spain, 08017
        • Pfizer Investigational Site
      • Cadiz, Spain, 11009
        • Pfizer Investigational Site
      • Gerona, Spain, 17007
        • Pfizer Investigational Site
      • Granada, Spain, 18012
        • Pfizer Investigational Site
      • Madrid, Spain, 28034
        • Pfizer Investigational Site
      • Madrid, Spain, 28040
        • Pfizer Investigational Site
      • Sevilla, Spain, 41014
        • Pfizer Investigational Site
      • Valencia, Spain, 46017
        • Pfizer Investigational Site
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Pfizer Investigational Site
    • Las Palmas de Gran Canaria
      • Las Palmas, Las Palmas de Gran Canaria, Spain, 35010
        • Pfizer Investigational Site
    • Vizcaya
      • Baracaldo, Vizcaya, Spain, 48903
        • Pfizer Investigational Site
      • Bilbao, Vizcaya, Spain, 48013
        • Pfizer Investigational Site
  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
        • Pfizer Investigational Site
      • Bolton, United Kingdom, BL3 6TL
        • Pfizer Investigational Site
      • Canterbury, United Kingdom, CT1 3HX
        • Pfizer Investigational Site
      • Liverpool, United Kingdom, L7 8XP
        • Pfizer Investigational Site
      • Salford, United Kingdom, M6 8HD
        • Pfizer Investigational Site
      • York, United Kingdom, YO31 8HE
        • Pfizer Investigational Site
    • Ayrshire
      • Ayr, Ayrshire, United Kingdom, KA7 1BJ
        • Pfizer Investigational Site
    • Cardiff
      • Thornhill, Cardiff, United Kingdom, CF14 9BB
        • Pfizer Investigational Site
    • Cornwall
      • Penzance, Cornwall, United Kingdom, TR18 4JH
        • Pfizer Investigational Site
      • St. Austell, Cornwall, United Kingdom, PL26 7RL
        • Pfizer Investigational Site
      • Truro, Cornwall, United Kingdom, TR1 3LJ
        • Pfizer Investigational Site
    • Devon
      • Plymouth, Devon, United Kingdom, PL6 8BX
        • Pfizer Investigational Site
    • Hertfordshire
      • Letchworth, Hertfordshire, United Kingdom, SG6 4UB
        • Pfizer Investigational Site
    • Kent
      • Sidcup, Kent, United Kingdom, DA14 6LT
        • Pfizer Investigational Site
      • Whitstable, Kent, United Kingdom, CT5 3QU
        • Pfizer Investigational Site
    • Lancashire
      • Blackpool, Lancashire, United Kingdom, FY3 7EN
        • Pfizer Investigational Site
    • Norwich
      • Colney, Norwich, United Kingdom, NR4 7UY
        • Pfizer Investigational Site
    • Oxford
      • Headington, Oxford, United Kingdom, OX3 7LJ
        • Pfizer Investigational Site
    • South Glamorgan
      • Penarth, South Glamorgan, United Kingdom, CF64 2XX
        • Pfizer Investigational Site
    • Tayside
      • Dundee, Tayside, United Kingdom, DD1 9SY
        • Pfizer Investigational Site
    • West Sussex
      • Haywards Heath, West Sussex, United Kingdom, RH16 4EX
        • Pfizer Investigational Site
  • United States
    • California
      • La Jolla, California, United States, 92037
        • Pfizer Investigational Site
      • San Diego, California, United States, 92128
        • Pfizer Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Pfizer Investigational Site
    • Florida
      • Jacksonville, Florida, United States, 32209
        • Pfizer Investigational Site
      • Jacksonville, Florida, United States, 32208
        • Pfizer Investigational Site
      • Miami, Florida, United States, 33136
        • Pfizer Investigational Site
    • Georgia
      • Columbus, Georgia, United States, 31904
        • Pfizer Investigational Site
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Pfizer Investigational Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Pfizer Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21230
        • Pfizer Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Pfizer Investigational Site
      • Charlotte, North Carolina, United States, 28212
        • Pfizer Investigational Site
      • Raleigh, North Carolina, United States, 27609
        • Pfizer Investigational Site
    • Oregon
      • Medford, Oregon, United States, 97504-8491
        • Pfizer Investigational Site
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033-0850
        • Pfizer Investigational Site
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Pfizer Investigational Site
    • Texas
      • San Antonio, Texas, United States, 78229
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78237
        • 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

35 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diabetes mellitus Type 2
  • Failing two or more oral anti-diabetic agents

Exclusion Criteria:

  • Asthma, COPD
  • 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
Patient satisfaction
Percent of patients achieving good control of fasting glucose and lipids
Rate of hypoglycemia
Changes in body weight
Safety based on adverse events reported and laboratory tests

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.

General Publications

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

April 1, 2005

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

August 22, 2005

First Submitted That Met QC Criteria

August 22, 2005

First Posted (Estimate)

August 24, 2005

Study Record Updates

Last Update Posted (Estimate)

April 17, 2008

Last Update Submitted That Met QC Criteria

April 16, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A2171018

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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