Status:
COMPLETED
Compare Two Dosing Algorithms in Insulin-Naive Patients With Type 2 Diabetes Mellitus
Lead Sponsor:
Eli Lilly and Company
Collaborating Sponsors:
Alkermes, Inc.
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This randomized, multicenter, open-label, active-comparator, 2-arm, parallel-group, 6 month study with approximately 360 patients will compare the efficacy of two treatment regimens (Algorithm A versu...
Eligibility Criteria
Inclusion
- Type 2 diabetes mellitus for at least 6 months
- Have a HbA1c greater than 7.0% and less than or equal to 10.5% at screening.
- Patients who have been treated with the following regimen:
- One or more oral antihyperglycemic medications on a stable dose for at least 6 weeks (12 weeks for thiazolidinediones \[TZDs\]),
- AND
- have been on insulin for 14 days or less throughout life and have not taken insulin within 6 months,
- AND
- are candidates for insulin therapy, in the opinion of the investigator.
Exclusion
- Pregnancy
- Smoker
- History of more than two episodes of severe hypoglycemia during the 6 months prior to study entry
- Diagnosed with pneumonia in the 3 months prior to screening
- Patients who have received systemic glucocorticoid therapy within 3 months prior to study entry
- History of renal transplantation
- History of lung transplantation
- Active or untreated malignancy
- Treated with Incretin mimetics
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
379 Patients enrolled
Trial Details
Trial ID
NCT00391209
Start Date
October 1 2006
End Date
May 1 2008
Last Update
March 9 2018
Active Locations (42)
Enter a location and click search to find clinical trials sorted by distance.
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.
Santa Ana, California, United States, 92705
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.
Washington D.C., District of Columbia, United States, 20010
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.
Hollywood, Florida, United States, 33021
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.
New Port Richey, Florida, United States, 34652