Comparing Intensive and Standard Training for Human Insulin Inhalation Powder (HIIP)
NCT ID: NCT00099515
Last Updated: 2007-12-21
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
PHASE2
97 participants
INTERVENTIONAL
2004-11-30
2005-09-30
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
LY041001 (HIIP)
Inhalation, capsule, TID 3 times per day min 6 IU max 60 IU
B
LY041001 (HIIP)
Inhalation, Capsule, TID 3 times per day min 6 IU max 60 IU
Interventions
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LY041001 (HIIP)
Inhalation, capsule, TID 3 times per day min 6 IU max 60 IU
LY041001 (HIIP)
Inhalation, Capsule, TID 3 times per day min 6 IU max 60 IU
Eligibility Criteria
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Inclusion Criteria
* Age 18 or older.
* Taking at least 1 oral antihyperglycemic medication.
* Have an HbA1C between 7.5 and 12.
* Be a nonsmoker
Exclusion Criteria
* Have frequent episodes of severe hypoglycemia.
* Have advanced autonomic neuropathy.
* Have history of asthma.
* Have chronic obstructive pulmonary disease (COPD).
18 Years
ALL
No
Sponsors
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Alkermes, Inc.
INDUSTRY
Eli Lilly and Company
INDUSTRY
Responsible Party
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Eli Lilly
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.
Clearwater, Florida, United States
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.
Buffalo, New York, United States
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.
New Hyde Park, New York, United States
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.
Sante Fe, Rosario, Argentina
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.
Norway, , Portugal
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.
George, , South Africa
Countries
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Other Identifiers
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H7U-MC-IDAP
Identifier Type: -
Identifier Source: secondary_id
9523
Identifier Type: -
Identifier Source: org_study_id