Status:
COMPLETED
A Study of LY2605541 in Participants With Type 1 Diabetes Mellitus
Lead Sponsor:
Eli Lilly and Company
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary purpose of participation in this study is to compare the safety and efficacy of different dosing schedules of LY2605541 and how different dosing schedules of LY2605541 affect Hemoglobin A1...
Detailed Description
This study involved a comparison of LY2605541 regimens, each administered with bolus insulin lispro. Eligible participants were switched to a fixed evening LY2605541dosing regimen at the beginning of ...
Eligibility Criteria
Inclusion
- Type 1 diabetes mellitus for at least 1 year
- Have an HbA1c value \<9.0%
- Have a body mass index (BMI) ≤35.0 kilogram per square meter (kg/m\^2)
- Currently using basal/ bolus insulin
- Women of childbearing potential are not breastfeeding and must use methods to prevent pregnancy
Exclusion
- Have excessive insulin resistance
- Are taking medications other than insulin for diabetes
- High triglycerides
- Have had more than 1 episode of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia as determined by the investigator) within 6 months prior to entry into the study
- Have had 2 or more emergency room visits or hospitalizations due to poor glucose control (hyperglycemia or diabetic ketoacidosis) in the past 6 months
- Have cardiac disease with functional status that is New York Heart Association (NYHA) Class III or IV (per NYHA Cardiac Disease Classification)
- Have impaired renal function
- Have impaired liver function
- Have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia, sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with HbA1c measurement
- Have cancer, recent cancer, or risk of cancer
- Have a known hypersensitivity or allergy to any of the study insulins or their excipients
- Have chronic systemic glucocorticoid users
- Have clinically significant diabetic autonomic neuropathy
- Have irregular sleep/wake cycle
- Have been treated with a drug within the last 30 days that has not received regulatory approval at the time of study entry
- Prior study participation
- Are using or have used niacin preparations as a lipid-lowering medication and/or bile acid sequestrants within 90 days prior to screening
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
212 Patients enrolled
Trial Details
Trial ID
NCT01792284
Start Date
February 1 2013
End Date
April 1 2014
Last Update
April 20 2018
Active Locations (18)
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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.
Concord, California, United States, 94520
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.
Escondido, California, United States, 92026
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.
Fresno, California, United States, 93720
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.
Tustin, California, United States, 92780