Status:
COMPLETED
A Study in Adults With Type 1 Diabetes
Lead Sponsor:
Eli Lilly and Company
Collaborating Sponsors:
Boehringer Ingelheim
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the effectiveness and safety of LY2963016 versus Lantus when taken once daily in combination with insulin lispro before meals three times a day.
Eligibility Criteria
Inclusion
- Have type 1 diabetes mellitus based on the disease diagnostic criteria \[World Health Organization (WHO) Classification\]
- Have duration of diabetes greater than or equal to one year
- Have Hemoglobin A1c (HbA1c) less than or equal to 11.0%
- On basal-bolus insulin therapy for at least 1 year \[basal insulin must be once daily (QD) injection of human insulin isophane suspension (NPH), Lantus, or detemir and combined with mealtime injections of human regular insulin, or insulin analog lispro, aspart or glulisine\]
- Have a body mass index (BMI) of less than or equal to 35 kilograms/square meter (kg/m²)
Exclusion
- 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 had more than one episode of diabetic ketoacidosis or emergency room visits for uncontrolled diabetes leading to hospitalization within the 6 months before entering the study
- Have known hypersensitivity or allergy to any of the study insulins (insulin glargine or insulin lispro) or to excipients of the study insulins
- Have significant renal, cardiac, gastrointestinal or liver disease
- Have active cancer or cancer within the past 5 years
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
536 Patients enrolled
Trial Details
Trial ID
NCT01421147
Start Date
August 1 2011
End Date
April 1 2013
Last Update
October 9 2014
Active Locations (52)
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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.
Birmingham, Alabama, United States, 35294
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.
Hollywood, Florida, United States, 33021
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.
New Port Richey, Florida, United States, 34652
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.
West Palm Beach, Florida, United States, 33401