Study of Human Insulin Inhalation Powder in Patients With Type 2 Diabetes
NCT ID: NCT00325364
Last Updated: 2019-09-16
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
415 participants
INTERVENTIONAL
2006-04-30
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
2
Injectable insulin
patient specific dose, injectable, before meals, 24 months
Interventions
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Human Insulin Inhalation Powder
patient specific dose, inhaled, before meals, 24 months
Injectable insulin
patient specific dose, injectable, before meals, 24 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Non smoker
* Normal lung function
Exclusion Criteria
* 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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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Sacramento, California, United States
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Santa Ana, California, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Baton Rouge, Louisiana, United States
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Hamilton, New Jersey, United States
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Greenville, South Carolina, United States
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Ogden, Utah, United States
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Charleston, West Virginia, United States
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Fortaleza, , Brazil
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Porto Alegre, , Brazil
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São Paulo, , Brazil
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Berlin, , Germany
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Dresden, , Germany
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Erlangen, , Germany
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Frankfurt, , Germany
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Leipzig, , Germany
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Mainz, , Germany
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Budapest, , Hungary
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Makó, , Hungary
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Veszprém, , Hungary
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Zalaegerszeg, , Hungary
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Bangalore, , India
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Mumbai, , India
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Pune, , India
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Catania, , Italy
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Genova, , Italy
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Milan, , Italy
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Pisa, , Italy
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Rome, , Italy
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Mexico City, , Mexico
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Monterrey, , Mexico
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Katowice, , Poland
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Lublin, , Poland
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Oleśnica, , Poland
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Coimbra, , Portugal
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Lisbon, , Portugal
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Manatí, , Puerto Rico
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San Juan, , Puerto Rico
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Yabucoa, , Puerto Rico
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Changhua, , Taiwan
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Neihu Taipei, , Taiwan
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Yungkang City, , Taiwan
Countries
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References
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Gross JL, Nakano M, Colon-Vega G, Ortiz-Carasquillo R, Ferguson JA, Althouse S, Tobian JA, Berclaz PY, Milicevic Z. Initiation of prandial insulin therapy with AIR inhaled insulin or insulin lispro in patients with type 2 diabetes: A randomized noninferiority trial. Diabetes Technol Ther. 2009 Sep;11 Suppl 2:S27-34. doi: 10.1089/dia.2009.0037.
Other Identifiers
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H7U-MC-IDAU
Identifier Type: OTHER
Identifier Source: secondary_id
9626
Identifier Type: -
Identifier Source: org_study_id
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