Effect of Inhaled Pre-prandial Human Insulin on Blood Glucose Control in Type 2 Diabetes
NCT ID: NCT00427154
Last Updated: 2018-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
227 participants
INTERVENTIONAL
2007-01-10
2008-03-11
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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A
inhaled human insulin
Treat-to-target dose titration scheme, inhalation.
metformin
Tablets, 2000 mg/day.
glimepiride
Tablets, 8 mg/day.
B
rosiglitazone
Tablets, 4 mg once or twice daily.
metformin
Tablets, 2000 mg/day.
glimepiride
Tablets, 8 mg/day.
Interventions
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rosiglitazone
Tablets, 4 mg once or twice daily.
inhaled human insulin
Treat-to-target dose titration scheme, inhalation.
metformin
Tablets, 2000 mg/day.
glimepiride
Tablets, 8 mg/day.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Currently treated with antidiabetes drugs (including Exenatide) for at least 2 months
* HbA1c between 7.5 and 11.0% (both inclusive) on antidiabetes combination therapy
* BMI less than or equal to 40 kg/m2
Exclusion Criteria
* Current acute or chronic pulmonary disease (except for asthma)
* Proliferative retinopathy requiring acute treatment
* Clinically significant disease history including kidney or liver disease
* Heart disease which limits physical activity or results in discomfort with physical activity
* Pregnancy
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Hueytown, Alabama, United States
Novo Nordisk Investigational Site
Ozark, Alabama, United States
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Tuscaloosa, Alabama, United States
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Vestavia Hills, Alabama, United States
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Tucson, Arizona, United States
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Concord, California, United States
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Escondido, California, United States
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Fresno, California, United States
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Huntington Beach, California, United States
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La Jolla, California, United States
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Orange, California, United States
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Poway, California, United States
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Roseville, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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Santa Barbara, California, United States
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Temecula, California, United States
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Walnut Creek, California, United States
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Colorado Springs, Colorado, United States
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Waterbury, Connecticut, United States
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Boca Raton, Florida, United States
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Clearwater, Florida, United States
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Hialeah, Florida, United States
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Hollywood, Florida, United States
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Lake Mary, Florida, United States
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Marianna, Florida, United States
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Melbourne, Florida, United States
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Merritt Island, Florida, United States
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Miami, Florida, United States
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Palm Harbor, Florida, United States
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Pembroke Pines, Florida, United States
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Vero Beach, Florida, United States
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West Palm Beach, Florida, United States
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Athens, Georgia, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Augusta, Georgia, United States
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Dunwoody, Georgia, United States
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Powder Springs, Georgia, United States
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Roswell, Georgia, United States
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Suwanee, Georgia, United States
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Tucker, Georgia, United States
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Honolulu, Hawaii, United States
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Boise, Idaho, United States
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Chicago, Illinois, United States
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Peoria, Illinois, United States
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Springfield, Illinois, United States
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Lafayette, Indiana, United States
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Des Moines, Iowa, United States
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Shawnee Mission, Kansas, United States
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Topeka, Kansas, United States
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Wichita, Kansas, United States
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Lexington, Kentucky, United States
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Scarborough, Maine, United States
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Baltimore, Maryland, United States
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Marlborough, Massachusetts, United States
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Springfield, Massachusetts, United States
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Jackson, Mississippi, United States
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Chesterfield, Missouri, United States
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Jefferson City, Missouri, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Billings, Montana, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Berlin, New Jersey, United States
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Cherry Hill, New Jersey, United States
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Lawrenceville, New Jersey, United States
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Staten Island, New York, United States
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Syracuse, New York, United States
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Asheville, North Carolina, United States
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Charlotte, North Carolina, United States
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Greenville, North Carolina, United States
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High Point, North Carolina, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Cleveland, Ohio, United States
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Dayton, Ohio, United States
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Dayton, Ohio, United States
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Clinton, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Medford, Oregon, United States
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Altoona, Pennsylvania, United States
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Beaver, Pennsylvania, United States
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Norristown, Pennsylvania, United States
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Greer, South Carolina, United States
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Chattanooga, Tennessee, United States
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Chattanooga, Tennessee, United States
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Clarksville, Tennessee, United States
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Kingsport, Tennessee, United States
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Arlington, 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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Hurst, Texas, United States
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Lewisville, Texas, United States
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San Antonio, Texas, United States
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Arlington, Virginia, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Warrenton, Virginia, United States
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Renton, Washington, United States
Novo Nordisk Investigational Site
Tacoma, Washington, United States
Countries
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Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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NN1998-1540
Identifier Type: -
Identifier Source: org_study_id
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