A Clinical Trial Assessing the Impact of the Availability of Inhaled Insulin on Glucose Control
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
1 other identifier
interventional
1,100
7 countries
121
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 diabetes-mellitus
Started Apr 2005
121 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 22, 2005
CompletedFirst Posted
Study publicly available on registry
August 24, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedApril 17, 2008
April 1, 2008
August 22, 2005
April 16, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
Glycosylated hemoglobin
Secondary Outcomes (5)
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
Interventions
Eligibility Criteria
You may qualify if:
- Diabetes mellitus Type 2
- Failing two or more oral anti-diabetic agents
You may not qualify if:
- Asthma, COPD
- Smoking
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (121)
Pfizer Investigational Site
La Jolla, California, 92037, United States
Pfizer Investigational Site
San Diego, California, 92128, United States
Pfizer Investigational Site
Washington D.C., District of Columbia, 20010, United States
Pfizer Investigational Site
Jacksonville, Florida, 32208, United States
Pfizer Investigational Site
Jacksonville, Florida, 32209, United States
Pfizer Investigational Site
Miami, Florida, 33136, United States
Pfizer Investigational Site
Columbus, Georgia, 31904, United States
Pfizer Investigational Site
Overland Park, Kansas, 66211, United States
Pfizer Investigational Site
New Orleans, Louisiana, 70121, United States
Pfizer Investigational Site
Baltimore, Maryland, 21230, United States
Pfizer Investigational Site
Charlotte, North Carolina, 28207, United States
Pfizer Investigational Site
Charlotte, North Carolina, 28212, United States
Pfizer Investigational Site
Raleigh, North Carolina, 27609, United States
Pfizer Investigational Site
Medford, Oregon, 97504-8491, United States
Pfizer Investigational Site
Hershey, Pennsylvania, 17033-0850, United States
Pfizer Investigational Site
Spartanburg, South Carolina, 29303, United States
Pfizer Investigational Site
San Antonio, Texas, 78229, United States
Pfizer Investigational Site
San Antonio, Texas, 78237, United States
Pfizer Investigational Site
Calgary, Alberta, T2L 1K8, Canada
Pfizer Investigational Site
Edmonton, Alberta, T5J 3N4, Canada
Pfizer Investigational Site
Red Deer, Alberta, T4N 6V7, Canada
Pfizer Investigational Site
Winnipeg, Manitoba, R3E 3P4, Canada
Pfizer Investigational Site
Corunna, Ontario, N0N 1G0, Canada
Pfizer Investigational Site
Oakville, Ontario, L6H 3P1, Canada
Pfizer Investigational Site
Smith Falls, Ontario, K7A 4W8, Canada
Pfizer Investigational Site
Charlottetown, Prince Edward Island, C1A 5Y9, Canada
Pfizer Investigational Site
Laval, Quebec, H7T 2P5, Canada
Pfizer Investigational Site
Montreal, Quebec, H3A 1A1, Canada
Pfizer Investigational Site
Béthune, 62408, France
Pfizer Investigational Site
Bourg-en-Bresse, 01012, France
Pfizer Investigational Site
Bron, 69500, France
Pfizer Investigational Site
Corbeil-Essonnes, 91106, France
Pfizer Investigational Site
La Rochelle, 17019, France
Pfizer Investigational Site
Montpellier, F-34295, France
Pfizer Investigational Site
Nantes, 44000, France
Pfizer Investigational Site
Roubaix, 59100, France
Pfizer Investigational Site
Tours, 37044, France
Pfizer Investigational Site
Altenburg, 04600, Germany
Pfizer Investigational Site
Aschaffenburg, 63739, Germany
Pfizer Investigational Site
Bad Mergentheim, 97980, Germany
Pfizer Investigational Site
Bad Oeynhausen/ Volmerdingen, 32549, Germany
Pfizer Investigational Site
Berlin, 10115, Germany
Pfizer Investigational Site
Berlin, 12687, Germany
Pfizer Investigational Site
Berlin, 14057, Germany
Pfizer Investigational Site
Delmenhorst, 27753, Germany
Pfizer Investigational Site
Dresden, 01219, Germany
Pfizer Investigational Site
Ebersdorf, 96237, Germany
Pfizer Investigational Site
Eisenach, 99817, Germany
Pfizer Investigational Site
Falkensee, 14612, Germany
Pfizer Investigational Site
Furth im Wald, 93437, Germany
Pfizer Investigational Site
Hamburg, 21073, Germany
Pfizer Investigational Site
Hamburg, 22391, Germany
Pfizer Investigational Site
Haßloch, 67454, Germany
Pfizer Investigational Site
Künzing, 94550, Germany
Pfizer Investigational Site
Leipzig, 04103, Germany
Pfizer Investigational Site
Meissen, 01662, Germany
Pfizer Investigational Site
Mittweida, 09648, Germany
Pfizer Investigational Site
Münster, 48145, Germany
Pfizer Investigational Site
Münster, 48153, Germany
Pfizer Investigational Site
Offenbach, 63065, Germany
Pfizer Investigational Site
Offenburg, 77654, Germany
Pfizer Investigational Site
Oschatz, 04758, Germany
Pfizer Investigational Site
Pirna, 01796, Germany
Pfizer Investigational Site
Riedlhuette, 94566, Germany
Pfizer Investigational Site
Riesa, 01587, Germany
Pfizer Investigational Site
Rossach, 96269, Germany
Pfizer Investigational Site
Schwabenheim, 55270, Germany
Pfizer Investigational Site
St.Ingbert, 66386, Germany
Pfizer Investigational Site
Surwold, 26903, Germany
Pfizer Investigational Site
Wangen, 88239, Germany
Pfizer Investigational Site
Wangen / Allgaeu, 88239, Germany
Pfizer Investigational Site
Witten, 58455, Germany
Pfizer Investigational Site
Bari, 70124, Italy
Pfizer Investigational Site
Catania, 95122, Italy
Pfizer Investigational Site
Florence, 50134, Italy
Pfizer Investigational Site
Genova, 16132, Italy
Pfizer Investigational Site
Milan, 20132, Italy
Pfizer Investigational Site
Napoli, 80131, Italy
Pfizer Investigational Site
Padua, 35128, Italy
Pfizer Investigational Site
Palermo, 90127, Italy
Pfizer Investigational Site
Pescara, 65100, Italy
Pfizer Investigational Site
Pisa, 56124, Italy
Pfizer Investigational Site
Roma, 00133, Italy
Pfizer Investigational Site
Torino, 10126, Italy
Pfizer Investigational Site
Udine, 33100, Italy
Pfizer Investigational Site
Verona, 37126, Italy
Pfizer Investigational Site
Badalona, Barcelona, 08916, Spain
Pfizer Investigational Site
Barcelona, BARCELONA, 08003, Spain
Pfizer Investigational Site
Barcelona, BARCELONA, 08017, Spain
Pfizer Investigational Site
Barcelona, BARCELONA, 08036, Spain
Pfizer Investigational Site
Cadiz, CADIZ, 11009, Spain
Pfizer Investigational Site
Girona, GERONA, 17007, Spain
Pfizer Investigational Site
Granada, GRANADA, 18012, Spain
Pfizer Investigational Site
Las Palmas, LAS Palmas de GRAN Canaria, 35010, Spain
Pfizer Investigational Site
Madrid, Madrid, 28034, Spain
Pfizer Investigational Site
Madrid, Madrid, 28040, Spain
Pfizer Investigational Site
Seville, SEVILLA, 41014, Spain
Pfizer Investigational Site
Valencia, Valencia, 46017, Spain
Pfizer Investigational Site
Barakaldo, VIZCAYA, 48903, Spain
Pfizer Investigational Site
Bilbao, VIZCAYA, 48013, Spain
Pfizer Investigational Site
Ayr, Ayrshire, KA7 1BJ, United Kingdom
Pfizer Investigational Site
Thornhill, Cardiff, CF14 9BB, United Kingdom
Pfizer Investigational Site
Penzance, CORNWALL, TR18 4JH, United Kingdom
Pfizer Investigational Site
St Austell, Cornwall, PL26 7RL, United Kingdom
Pfizer Investigational Site
Truro, Cornwall, TR1 3LJ, United Kingdom
Pfizer Investigational Site
Plymouth, DEVON, PL6 8BX, United Kingdom
Pfizer Investigational Site
Letchworth Garden City, Hertfordshire, SG6 4UB, United Kingdom
Pfizer Investigational Site
Sidcup, Kent, DA14 6LT, United Kingdom
Pfizer Investigational Site
Whitstable, Kent, CT5 3QU, United Kingdom
Pfizer Investigational Site
Blackpool, Lancashire, FY3 7EN, United Kingdom
Pfizer Investigational Site
Colney, Norwich, NR4 7UY, United Kingdom
Pfizer Investigational Site
Headington, Oxford, OX3 7LJ, United Kingdom
Pfizer Investigational Site
Penarth, South Glamorgan, CF64 2XX, United Kingdom
Pfizer Investigational Site
Dundee, Tayside, DD1 9SY, United Kingdom
Pfizer Investigational Site
Haywards Heath, West Sussex, RH16 4EX, United Kingdom
Pfizer Investigational Site
Birmingham, B9 5SS, United Kingdom
Pfizer Investigational Site
Bolton, BL3 6TL, United Kingdom
Pfizer Investigational Site
Canterbury, CT1 3HX, United Kingdom
Pfizer Investigational Site
Liverpool, L7 8XP, United Kingdom
Pfizer Investigational Site
Salford, M6 8HD, United Kingdom
Pfizer Investigational Site
York, YO31 8HE, United Kingdom
Related Publications (1)
Freemantle N, Strack TR; Real World Trialists. Will availability of inhaled human insulin (Exubera) improve management of type 2 diabetes? The design of the Real World trial. Trials. 2006 Aug 10;7:25. doi: 10.1186/1745-6215-7-25.
PMID: 16901335DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 22, 2005
First Posted
August 24, 2005
Study Start
April 1, 2005
Study Completion
May 1, 2007
Last Updated
April 17, 2008
Record last verified: 2008-04