Status:
COMPLETED
Evaluate the Efficacy and Safety of Insulin Compared to Glargine 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 compare Human Inhalation Powder (also known as AIR® Inhaled Insulin) (AIR® is a registered trademark of Alkermes, Inc.)with insulin glargine injections in patients with Type 2 diabetes who ...
Eligibility Criteria
Inclusion
- Type 2 Diabetes Mellitus
- Insulin naive
- One or more oral antihyperglycemic medications
- HbA1c greater than or equal to 8.0% and less than or equal to 10.5%
- Non-smoker
Exclusion
- Taking a TZD dose greater than what is indicated
- Have not taken insulin within 6 months of entry into study
- Have had more than 2 episodes of sever hypoglycemia during the 6 months prior to study entry
- Have had more than 1 hospitalization or emergency room visit due to poor diabetic control during the 6 months prior to study entry
- Have had pneumonia in the 3 months prior to study entry
- Systemic glucocorticoid therapy
- Clinical signs or symptoms of liver disease, acute or chronic hepatitis
- History of renal transplantation
- Have an active or untreated malignancy
- Have a current diagnosis or past history of clinically relevant pulmonary disease
- Taking or have taken exenatide during the 6 weeks prior to study entry
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT00437112
Start Date
February 1 2007
End Date
May 1 2008
Last Update
March 9 2018
Active Locations (19)
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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.
Greenbrae, California, United States, 94904
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.
Topeka, Kansas, United States, 66606
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.
Toms River, New Jersey, United States, 08753
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.
Albuquerque, New Mexico, United States, 87108