Status:
COMPLETED
The DURABLE Trial: Evaluating the Durability of Starter Insulin Regimens in Patients With Type 2 Diabetes (IOOV)
Lead Sponsor:
Eli Lilly and Company
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
30-79 years
Phase:
PHASE4
Brief Summary
This study will compare insulin lispro low mixture \[LM\] and insulin glargine both in combination with the patient's oral diabetes medicines, for their ability to control blood sugar in patients with...
Eligibility Criteria
Inclusion
- Must have type 2 diabetes.
- Must be at least 30 and less than 80 years of age at the time of Visit 1.
- Must be on at least two oral antidiabetes medications for at least 90 days.
- Must have an HbA1c 1.2 to 2.0 times the upper limit of normal reference range at the local lab.
Exclusion
- Must not have used insulin on a regular basis in the last 12 months.
- Must not have had more than one episode of severe hypoglycemia in the last 24 weeks.
- Must not have a body mass index (BMI) of greater than 45 (morbid obesity).
- Must not have clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease.
- Must not be pregnant or intend to get pregnant during course of the study.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
2091 Patients enrolled
Trial Details
Trial ID
NCT00279201
Start Date
December 1 2005
End Date
November 1 2009
Last Update
February 21 2011
Active Locations (199)
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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.
Mobile, Alabama, United States, 36617
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.
Litchfield Park, Arizona, United States, 85340
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.
Little Rock, Arkansas, United States, 72205
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.
Anaheim, California, United States, 92805