Status:
COMPLETED
Evaluate the Efficacy and Safety of Insulin in Patients With Type 2 Diabetes
Lead Sponsor:
Eli Lilly and Company
Collaborating Sponsors:
Alkermes, Inc.
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
A study to evaluate the efficacy and safety of Human Insulin Inhalation Powder \[also known as AIR® Inhaled Insulin\]\[AIR® is a registered trademark of Alkermes,Inc.\] in patients with Type 2 diabete...
Eligibility Criteria
Inclusion
- type 2 diabetes mellitus
- one or more oral antihyperglycemic medications
- once-daily insulin glargine
- HbA1c greater than or equal to 7.5 and less than or equal to 10.5%
- Non-smoker
Exclusion
- taking a TZD dose greater than what is indicated
- more than two episodes of severe hypoglycemia during the 6 months prior
- Have had a lower respiratory infection in the 3 months prior
- systemic glucocorticoid therapy
- clinical signs or symptoms of liver disease, acute or chronic hepatitis
- history of renal transplantation
- Have an active or untreated malignancy
- Require more than 150 U/day of insulin glargine
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
555 Patients enrolled
Trial Details
Trial ID
NCT00355849
Start Date
August 1 2006
End Date
June 1 2008
Last Update
September 16 2019
Active Locations (69)
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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.
Fresno, California, United States, 93720
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.
Pomona, California, United States, 91767
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.
West Palm Beach, Florida, United States, 33401
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.
Atlanta, Georgia, United States, 30309