This Study Is To Determine If Inhaled Insulin Is Effective In Treating Type 2 Diabetes Mellitus
NCT ID: NCT00418522
Last Updated: 2018-09-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
413 participants
INTERVENTIONAL
2007-03-31
2008-08-31
Brief Summary
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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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Insulin glargine
Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
Insulin glargine
Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
Exubera
Initiation dose of one mg per meal, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
Inhaled Insulin (Exubera)
Initiation dose of one mg per meal, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
Interventions
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Insulin glargine
Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
Inhaled Insulin (Exubera)
Initiation dose of one mg per meal, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
Eligibility Criteria
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Inclusion Criteria
* Screening HbA1c \> 7.0%
* Currently treated on a stable dose of at least 2 oral antidiabetic agents for at least 3 months prior to study entry; including a sulfonylurea and/or metformin, and/or a thiazolidinedione
Exclusion Criteria
* Type 1 diabetes mellitus
* Type 2 diabetes mellitus currently (last three months) treated with an insulin regimen (alone or with Oral Antidiabetic Agents)
* Active liver disease; significantly-impaired hepatic function, as shown by, but not limited to, alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT) or aspartate transaminase (AST) serum glutamic-oxaloacetic transaminase (SGOT) above 2x the upper limit of normal as measured at visit 1. However, patients with elevated ALT \>1.5 upper limit of normal as a result of hepatic steatosis are permitted to enter the study.
30 Years
75 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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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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Concord, California, United States
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Encino, California, United States
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Fresno, California, United States
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Fullerton, California, United States
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Long Beach, California, United States
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Mission Viejo, California, United States
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Pasadena, 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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Spring Valley, California, United States
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Stockton, California, United States
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Walnut Creek, California, United States
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West Hills, California, United States
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Golden, Colorado, United States
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Waterbury, Connecticut, United States
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Newark, Delaware, United States
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Chiefland, Florida, United States
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Clearwater, Florida, United States
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Hollywood, Florida, United States
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Kissimmee, Florida, United States
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Miami, Florida, United States
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Ocala, Florida, United States
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Saint Cloud, Florida, United States
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Winter Park, Florida, United States
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Atlanta, Georgia, United States
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Lawrenceville, Georgia, United States
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Lawrenceville, Georgia, United States
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Woodstock, Georgia, United States
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Boise, Idaho, United States
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Hayden Lake, Idaho, United States
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Indianapolis, Indiana, United States
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Overland Park, Kansas, United States
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Topeka, Kansas, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Baton Rouge, Louisiana, United States
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New Orleans, Louisiana, United States
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Haverhill, Massachusetts, United States
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Springfield, Missouri, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Staten Island, New York, United States
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Charlotte, North Carolina, United States
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Statesville, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Kettering, Ohio, United States
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Maumee, Ohio, United States
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Toledo, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Medford, Oregon, United States
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Melrose Park, Pennsylvania, United States
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Greenville, South Carolina, United States
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Greer, South Carolina, United States
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Spartanburg, South Carolina, United States
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Milan, Tennessee, United States
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Arlington, Texas, United States
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Beaumont, 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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El Paso, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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Bennington, Vermont, United States
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Richmond, Virginia, United States
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Federal Way, Washington, United States
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Menomonee Falls, Wisconsin, United States
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Carolina, , Puerto Rico
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A2171095
Identifier Type: -
Identifier Source: org_study_id
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