Efficacy and Safety of Inhaled Insulin Compared With Subcutaneous Human Insulin Therapy in Adults With Type 2 Diabetes
NCT ID: NCT00136916
Last Updated: 2010-02-18
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
635 participants
INTERVENTIONAL
2002-06-30
2008-12-31
Brief Summary
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This study included a 2-year comparative treatment period followed by a 6-month follow-up period during which inhaled insulin-treated subjects were switched back to subcutaneous short-acting insulin. After this follow-up period, all eligible subjects entered a comparative extension period that was to last for 5 years. When the comparative portion of the study was terminated, all subjects were requested to return for a final extension follow-up month 3 visit.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Inhaled Insulin
Inhalable short-acting insulin
Inhaled Insulin
Inhaled insulin with dose adjusted according to premeal blood glucose
Subcutaneous insulin
Subcutaneous insulin
Subcutaneous insulin with dose adjusted according to premeal blood glucose
Interventions
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Inhaled Insulin
Inhaled insulin with dose adjusted according to premeal blood glucose
Subcutaneous insulin
Subcutaneous insulin with dose adjusted according to premeal blood glucose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Asthma
* Smoking Pregnancy
35 Years
75 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Pfizer, Inc.
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Fresno, California, United States
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Greenbrae, California, United States
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Los Angeles, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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San Diego, California, United States
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San Luis Obispo, California, United States
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Tustin, California, United States
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Walnut Creek, California, United States
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Denver, Colorado, United States
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Hamden, Connecticut, United States
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Madison, Connecticut, United States
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New Britain, Connecticut, United States
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Waterbury, Connecticut, United States
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Chiefland, Florida, United States
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Clearwater, Florida, United States
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Fort Myers, Florida, United States
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Hollywood, Florida, United States
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Miami, Florida, United States
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Ocala, Florida, United States
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Palm Harbor, Florida, United States
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Tallahassee, Florida, United States
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West Palm Beach, Florida, United States
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Honolulu, Hawaii, United States
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Honolulu, Hawaii, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Springfield, Illinois, United States
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Wilmette, Illinois, United States
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New Orleans, Louisiana, United States
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Bethesda, Maryland, United States
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Boston, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Bloomfield Hills, Michigan, United States
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Plymouth, Michigan, United States
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Royal Oak, Michigan, United States
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Southfield, Michigan, United States
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Chesterfield, Missouri, United States
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St Louis, Missouri, United States
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Butte, Montana, United States
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Lincoln, Nebraska, United States
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Henderson, Nevada, United States
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Albuquerque, New Mexico, United States
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Albuquerque, New Mexico, United States
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Mineola, New York, United States
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New Hyde Park, New York, United States
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Rochester, New York, United States
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Durham, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Mansfield, Ohio, United States
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Tulsa, Oklahoma, United States
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Warwick, Rhode Island, United States
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Beaumont, Texas, United States
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Beaumont, Texas, United States
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Corpus Christi, Texas, United States
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Corpus Christi, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Irving, Texas, United States
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San Antonio, Texas, United States
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Burlington, Vermont, United States
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Richmond, Virginia, United States
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Renton, Washington, United States
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Milwaukee, Wisconsin, United States
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Porto Alegre, Rio Grande do Sul, Brazil
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São Paulo, São Paulo, Brazil
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Calgary, Alberta, Canada
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Calgary, Alberta, Canada
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Red Deer, Alberta, Canada
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Victoria, British Columbia, Canada
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Winnepeg, Manitoba, Canada
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Winnipeg, Manitoba, Canada
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Halifax, Nova Scotia, Canada
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Halifax, Nova Scotia, Canada
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London, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Laval, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
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Aguas Buenas, , Puerto Rico
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Añasco, , Puerto Rico
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Cabo Rojo, , Puerto Rico
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San Juan, , Puerto Rico
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San Juan, , Puerto Rico
Countries
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References
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Rosenstock J, Cefalu WT, Hollander PA, Klioze SS, Reis J, Duggan WT. Safety and efficacy of inhaled human insulin (exubera) during discontinuation and readministration of therapy in adults with type 2 diabetes: a 3-year randomized controlled trial. Diabetes Technol Ther. 2009 Nov;11(11):697-705. doi: 10.1089/dia.2009.0062.
Rosenstock J, Cefalu WT, Hollander PA, Belanger A, Eliaschewitz FG, Gross JL, Klioze SS, St Aubin LB, Foyt H, Ogawa M, Duggan WT. Two-year pulmonary safety and efficacy of inhaled human insulin (Exubera) in adult patients with type 2 diabetes. Diabetes Care. 2008 Sep;31(9):1723-8. doi: 10.2337/dc08-0159. Epub 2008 Jun 5.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A2171029
Identifier Type: -
Identifier Source: org_study_id
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