Status:
COMPLETED
Evaluate the Efficacy of Insulin Patients With Type 1 Diabetes
Lead Sponsor:
Eli Lilly and Company
Collaborating Sponsors:
Alkermes, Inc.
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
A study to test for non-inferiority of preprandial HIIP \[also known as AIR® Inhaled Insulin Powder\]\[AIR® is a registered trademark of Alkermes,Inc.\] compared with preprandial injectable insulin (i...
Eligibility Criteria
Inclusion
- Type 1 diabetes for at least 24 months
- Have an HbA1c less than or equal to 11%
- Patients who are on an insulin regimen involving 2 or 3 preprandial injections per day for at least 2 months
- Non-smoker
Exclusion
- Require a daily total insulin dosage greater than 150 U at screening
- Patients who have a current or past history of asthma, chronic obstructive pulmonary disease, other clinically relevant pulmonary disease
- Systemic glucocorticoid therapy
- Clinical signs or symptoms of liver disease, acute or chronic hepatitis
- History of lung transplantation and/or lung cancer
- Diagnosed with pneumonia in the 3 months prior to screening
- History of renal transplantation
- Active or untreated malignancy
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
494 Patients enrolled
Trial Details
Trial ID
NCT00356109
Start Date
August 1 2006
End Date
May 1 2008
Last Update
March 9 2018
Active Locations (37)
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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.
Aurora, Colorado, United States, 80045
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.
Miami, Florida, United States, 33136
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.
Atlanta, Georgia, United States, 30309
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.
Idaho Falls, Idaho, United States, 83404