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/PHASE3
70 participants
INTERVENTIONAL
2007-04-30
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
CROSSOVER
TREATMENT
NONE
Study Groups
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1
Insulin glargine
Patient specific, injected, daily, 24 weeks
Human Insulin Inhalation Powder
patient specific dose, inhaled, before meals,12 weeks
Injectable Insulin
Patient specific dose,injected, before meals, 12 weeks
2
Insulin glargine
Patient specific, injected, daily, 24 weeks
Human Insulin Inhalation Powder
patient specific dose, inhaled, before meals,12 weeks
Injectable Insulin
Patient specific dose,injected, before meals, 12 weeks
Interventions
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Insulin glargine
Patient specific, injected, daily, 24 weeks
Human Insulin Inhalation Powder
patient specific dose, inhaled, before meals,12 weeks
Injectable Insulin
Patient specific dose,injected, before meals, 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Injecting insulin (insulin lispro, aspart or regular insulin, insulin lispro/aspart mixtures, or regular human insulin mixtures) in the last 24 months
* HbA1c equal or less than 11 %
* Nonsmokers, had not smoked for at least 6 months and agree not to smoke (cigars, cigarettes or pipes) or use smokeless tobacco for the duration of the study
* Satisfactory lung function results to meet the requirement of the study
Exclusion Criteria
* Require a daily total insulin dosage greater than 100 U
* Have a current or past history of asthma, chronic obstructive pulmonary disease or other clinically relevant lung disease
* History or presence of liver disease
* History or presence of kidney disease
20 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 (1-277-285-4559) 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.
Kanagawa, , Japan
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.
Tokyo, , Japan
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.
Changhua, , Taiwan
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.
Taipei, , Taiwan
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.
Taoyuan District, , Taiwan
Countries
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References
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Hitoshi Ishii, Satoru Tsujii, Masami Tanaka, Miyuki Furuya, Tadao Iburi, Rei Ueda, Sakura Okuyama, Risa P. Hayes, Masato Okamura, Kazuya Iwamoto, Eisei Oda. Development of IDSQ-J and assessment of reproducibility adequacy. Tonyobyo. 2009;52(3):209-221.
Other Identifiers
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H7U-JE-IDBB
Identifier Type: -
Identifier Source: secondary_id
10299
Identifier Type: -
Identifier Source: org_study_id