Status:
COMPLETED
Comparing Pre-Mixed Insulin With Insulin Glargine Combined With Rapid-Acting Insulin in Patients With Type 2 Diabetes
Lead Sponsor:
Eli Lilly and Company
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
30-75 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare Lispro Mixture Therapy (insulin lispro 50/50 given three times daily with meals) to Glargine Basal-Bolus Therapy (insulin glargine daily with the addition of in...
Eligibility Criteria
Inclusion
- Must have type 2 diabetes.
- Must be 30-75 years of age at the time of Visit 1.
- Must be on insulin glargine and oral antidiabetic medicines for at least 90 days.
- Must be on at least 30 units of glargine per day at enrollment.
- Have an A1C between 7.5% and 12.0% at Visit 1.
Exclusion
- Must not have used rapid/short-acting insulin on a regular basis in the last 6 months.
- Must not have more than one episode of severe hypoglycemia in the last 6 months.
- Must not have a body mass index (BMI) of greater than 45 (morbid obesity).
- Must not have congestive heart failure that requires medications.
- Must not have had a kidney transplant or currently receiving dialysis
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
End Date :
April 1 2006
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00110370
Start Date
April 1 2004
End Date
April 1 2006
Last Update
November 27 2007
Active Locations (48)
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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.
Anniston, Alabama, United States
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.
Birmingham, Alabama, United States
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.
Phoenix, Arizona, United States
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.
Concord, California, United States