Study of Human Insulin Inhalation Powder in Patients With Type 1 Diabetes
NCT ID: NCT00127634
Last Updated: 2018-03-09
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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COMPLETED
PHASE3
385 participants
INTERVENTIONAL
2005-07-31
2008-05-31
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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1
Human Insulin Inhalation Powder
patient specific dose, inhaled, before meals, 24 months, up to 36 months
Insulin Glargine
patient specific dose, injectable, as needed, 24 months up to 36 months
2
Injectable Insulin
patient specific dose, injectable, before meals, 24 months, up to 36 months.
Insulin Glargine
patient specific dose, injectable, as needed, 24 months up to 36 months
Interventions
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Human Insulin Inhalation Powder
patient specific dose, inhaled, before meals, 24 months, up to 36 months
Injectable Insulin
patient specific dose, injectable, before meals, 24 months, up to 36 months.
Insulin Glargine
patient specific dose, injectable, as needed, 24 months up to 36 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Non smoker
* Normal lung function
Exclusion Criteria
* Severe congestive heart failure
* Active malignancy
* Systemic glucocorticoid therapy
18 Years
ALL
No
Sponsors
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Alkermes, Inc.
INDUSTRY
Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Sacramento, California, United States
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Walnut Creek, California, United States
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Aurora, Colorado, United States
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Denver, Colorado, United States
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Newark, Delaware, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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Largo, Florida, United States
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New Port Richey, Florida, United States
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West Palm Beach, Florida, United States
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Atlanta, Georgia, United States
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Idaho Falls, Idaho, United States
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Chicago, Illinois, United States
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Springfield, Illinois, United States
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Indianapolis, Indiana, United States
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Louisville, Kentucky, United States
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Baltimore, Maryland, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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North Plainfield, New Jersey, United States
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Flushing, New York, United States
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Lake Success, New York, United States
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New Hyde Park, New York, United States
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Staten Island, New York, United States
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Morehead City, North Carolina, United States
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Raleigh, North Carolina, United States
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Medford, Oregon, United States
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Downingtown, Pennsylvania, United States
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Sellersville, Pennsylvania, United States
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Sioux Falls, South Dakota, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Renton, Washington, United States
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Milwaukee, Wisconsin, United States
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Aalst, , Belgium
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Arlon, , Belgium
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Brussels, , Belgium
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Edegem, , Belgium
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Leuven, , Belgium
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Liège, , Belgium
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Winnipeg, Manitoba, Canada
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Corunna, Ontario, Canada
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Niagara Falls, Ontario, Canada
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Peterborough, Ontario, Canada
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Sarnia, Ontario, Canada
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Montreal, Quebec, Canada
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Zagreb, , Croatia
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Budapest, , Hungary
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Debrecen, , Hungary
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Eger, , Hungary
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Gyula, , Hungary
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Kecskemét, , Hungary
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Nyíregyháza, , Hungary
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Szeged, , Hungary
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Szolnok, , Hungary
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Bangalore, , India
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Kochi, , India
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Mumbai, , India
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New Dehli, , India
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Noida, , India
Countries
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References
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Garg SK, Mathieu C, Rais N, Gao H, Tobian JA, Gates JR, Ferguson JA, Webb DM, Berclaz PY. Two-year efficacy and safety of AIR inhaled insulin in patients with type 1 diabetes: An open-label randomized controlled trial. Diabetes Technol Ther. 2009 Sep;11 Suppl 2:S5-S16. doi: 10.1089/dia.2009.0040.
Other Identifiers
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H7U-MC-IDAH
Identifier Type: -
Identifier Source: secondary_id
6120
Identifier Type: -
Identifier Source: org_study_id
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