Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00134147
First received: August 22, 2005
Last updated: April 16, 2008
Last verified: April 2008
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus
Drug: Inhaled Insulin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Glycosylated hemoglobin

Secondary Outcome Measures:
  • Percent of patients achieving good control of fasting glucose and lipids
  • Rate of hypoglycemia
  • Changes in body weight
  • Patient satisfaction
  • Safety based on adverse events reported and laboratory tests

Estimated Enrollment: 1100
Study Start Date: April 2005
Study Completion Date: May 2007
  Eligibility

Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Asthma, COPD
  • Smoking
  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: NCT00134147

  Hide Study Locations
Locations
United States, California
Pfizer Investigational Site
La Jolla, California, United States, 92037
Pfizer Investigational Site
San Diego, California, United States, 92128
United States, District of Columbia
Pfizer Investigational Site
Washington, District of Columbia, United States, 20010
United States, Florida
Pfizer Investigational Site
Jacksonville, Florida, United States, 32208
Pfizer Investigational Site
Jacksonville, Florida, United States, 32209
Pfizer Investigational Site
Miami, Florida, United States, 33136
United States, Georgia
Pfizer Investigational Site
Columbus, Georgia, United States, 31904
United States, Kansas
Pfizer Investigational Site
Overland Park, Kansas, United States, 66211
United States, Louisiana
Pfizer Investigational Site
New Orleans, Louisiana, United States, 70121
United States, Maryland
Pfizer Investigational Site
Baltimore, Maryland, United States, 21230
United States, North Carolina
Pfizer Investigational Site
Charlotte, North Carolina, United States, 28212
Pfizer Investigational Site
Charlotte, North Carolina, United States, 28207
Pfizer Investigational Site
Raleigh, North Carolina, United States, 27609
United States, Oregon
Pfizer Investigational Site
Medford, Oregon, United States, 97504-8491
United States, Pennsylvania
Pfizer Investigational Site
Hershey, Pennsylvania, United States, 17033-0850
United States, South Carolina
Pfizer Investigational Site
Spartanburg, South Carolina, United States, 29303
United States, Texas
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
Pfizer Investigational Site
San Antonio, Texas, United States, 78237
Canada, Alberta
Pfizer Investigational Site
Calgary, Alberta, Canada, T2L 1K8
Pfizer Investigational Site
Edmonton, Alberta, Canada, T5J 3N4
Pfizer Investigational Site
Red Deer, Alberta, Canada, T4N 6V7
Canada, Manitoba
Pfizer Investigational Site
Winnipeg, Manitoba, Canada, R3E 3P4
Canada, Ontario
Pfizer Investigational Site
Corunna, Ontario, Canada, N0N 1G0
Pfizer Investigational Site
Oakville, Ontario, Canada, L6H 3P1
Pfizer Investigational Site
Smith Falls, Ontario, Canada, K7A 4W8
Canada, Prince Edward Island
Pfizer Investigational Site
Charlottetown, Prince Edward Island, Canada, C1A 5Y9
Canada, Quebec
Pfizer Investigational Site
Laval, Quebec, Canada, H7T 2P5
Pfizer Investigational Site
Montreal, Quebec, Canada, H3A 1A1
France
Pfizer Investigational Site
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
Germany
Pfizer Investigational Site
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, 12687
Pfizer Investigational Site
Berlin, Germany, 14057
Pfizer Investigational Site
Berlin, Germany, 10115
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, 22391
Pfizer Investigational Site
Hamburg, Germany, 21073
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, 48153
Pfizer Investigational Site
Muenster, Germany, 48145
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
Italy
Pfizer Investigational Site
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
Spain
Pfizer Investigational Site
Badalona, Barcelona, Spain, 08916
Pfizer Investigational Site
Las Palmas, Las Palmas de Gran Canaria, Spain, 35010
Pfizer Investigational Site
Baracaldo, Vizcaya, Spain, 48903
Pfizer Investigational Site
Bilbao, Vizcaya, Spain, 48013
Pfizer Investigational Site
Barcelona, Spain, 08003
Pfizer Investigational Site
Barcelona, Spain, 08017
Pfizer Investigational Site
Barcelona, Spain, 08036
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
United Kingdom
Pfizer Investigational Site
Ayr, Ayrshire, United Kingdom, KA7 1BJ
Pfizer Investigational Site
Thornhill, Cardiff, United Kingdom, CF14 9BB
Pfizer Investigational Site
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
Plymouth, Devon, United Kingdom, PL6 8BX
Pfizer Investigational Site
Letchworth, Hertfordshire, United Kingdom, SG6 4UB
Pfizer Investigational Site
Sidcup, Kent, United Kingdom, DA14 6LT
Pfizer Investigational Site
Whitstable, Kent, United Kingdom, CT5 3QU
Pfizer Investigational Site
Blackpool, Lancashire, United Kingdom, FY3 7EN
Pfizer Investigational Site
Colney, Norwich, United Kingdom, NR4 7UY
Pfizer Investigational Site
Headington, Oxford, United Kingdom, OX3 7LJ
Pfizer Investigational Site
Penarth, South Glamorgan, United Kingdom, CF64 2XX
Pfizer Investigational Site
Dundee, Tayside, United Kingdom, DD1 9SY
Pfizer Investigational Site
Haywards Heath, West Sussex, United Kingdom, RH16 4EX
Pfizer Investigational Site
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
Sponsors and Collaborators
Pfizer
Sanofi
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00134147     History of Changes
Other Study ID Numbers: A2171018
Study First Received: August 22, 2005
Last Updated: April 16, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014