Status:
COMPLETED
A Study for Patients With Type 1 Diabetes Mellitus
Lead Sponsor:
Eli Lilly and Company
Collaborating Sponsors:
Alkermes, Inc.
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
20+ years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of the study is to compare the human insulin inhalation powder plus insulin glargine with injected insulin (regular human insulin or insulin lispro) plus insulin glargine on lowering the b...
Eligibility Criteria
Inclusion
- Type 1 diabetes mellitus for at least 24 months
- 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
- Previously received any form of inhaled insulin
- 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
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00447213
Start Date
April 1 2007
End Date
May 1 2008
Last Update
October 13 2010
Active Locations (5)
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1
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, 235-0045
2
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, 160-0023
3
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, 500
4
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, 104