Status:
COMPLETED
A Study in Adults With Type 2 Diabetes
Lead Sponsor:
Eli Lilly and Company
Collaborating Sponsors:
Boehringer Ingelheim
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The main purpose of this study is to compare the effectiveness and safety of LY2963016 versus Lantus in controlling blood sugar levels in combination with two or more oral diabetes medications.
Eligibility Criteria
Inclusion
- Have Type 2 Diabetes Mellitus based on the disease diagnostic criteria World Health Organization (WHO) classification
- Have been taking at least 2 types of oral diabetes medications for at least 12 weeks prior to entering the study
- Have a Hemoglobin A1c value greater than or equal to 7.0 percent and less than or equal to 11.0 percent if insulin naive If previously on Lantus, then Hemoglobin A1c must be less than or equal to 11.0 percent
- Have a body mass index of less than or equal to 45 kilogram per meter squared (kg/m\^2)
Exclusion
- Have significant liver, cardiac or gastrointestinal disease
- Have active cancer or have had cancer within the past 5 years (with the exception of basal cell carcinoma or carcinoma in situ)
- Have an excessive resistance to insulin or hypersensitivity to Lantus
- Have had more than one episode of severe low blood sugar (defined as needing someone else to help because you had very low blood sugar) within the 6 months before entering the study
- Have taken any other insulin other than Lantus within the past 30 days
- Taking any other diabetes medicines that are not allowed in the study or not approved to be taken with insulin
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
759 Patients enrolled
Trial Details
Trial ID
NCT01421459
Start Date
September 1 2011
End Date
September 1 2012
Last Update
December 18 2014
Active Locations (62)
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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.
Montgomery, Alabama, United States, 36106
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.
Brooksville, Florida, United States, 34601
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.
Fort Lauderdale, Florida, United States, 33316
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