Status:
COMPLETED
A Study in Patients With Type 2 Diabetes Mellitus
Lead Sponsor:
Eli Lilly and Company
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is: * To compare blood sugar control on LY2605541 with insulin glargine after 52 weeks of treatment. * To compare the rate of night time low blood sugar episodes on LY260554...
Eligibility Criteria
Inclusion
- Have type 2 diabetes mellitus, not treated with insulin, for at least 1 year prior to the study
- Have been receiving at least 2 OAMs for at least 3 months before entering the study
- Have a hemoglobin A1c (HbA1c) value between 7.0% and 11.0%, inclusive, at screening
- Are capable of and willing to inject insulin with a vial and syringe and perform self blood glucose monitoring
- Women of childbearing potential only: are not breastfeeding, have a negative pregnancy test at the time of screening and randomization, intend to not become pregnant during the trial, have practiced a reliable method of birth control for at least 6 weeks prior to screening, and agree to use a reliable method of birth control during the study and until 2 weeks following the last dose of study drug
Exclusion
- Have used insulin therapy (outside of pregnancy) anytime in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 continuous weeks
- Use of rosiglitazone, pramlintide, or glucagon-like peptide 1 (GLP-1) receptor agonist (for example, exenatide, exenatide once weekly, or liraglutide) concurrently or within 3 months prior to screening
- Are currently taking, or have taken within the 3 months preceding screening, medications to promote weight loss
- Have had any episodes of severe hypoglycemia within 6 months prior to screening
- Have had 1 or more episodes of ketoacidosis or hyperosmolar state/coma in the 6 months prior to the study
- Have cardiac disease with functional status that is New York Heart Association Class III or IV (per New York Heart Association \[NYHA\] Cardiac Disease Classification)
- Have a history of renal transplantation, or are currently receiving renal dialysis or have serum creatinine greater or equal than 2 milligrams per deciliter (mg/dL)
- Have obvious clinical signs or symptoms of liver disease (excluding non- alcoholic fatty liver disease \[NAFLD\]), acute or chronic hepatitis, non-alcoholic steatohepatitis (NASH), or elevated liver enzyme measurements at screening
- Have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c
- Have active or untreated malignancy or have been in remission from clinically significant malignancy for less than 5 years
- Have fasting or non-fasting triglycerides greater than 400 mg/dL (greater than 4.5 millimoles per liter \[mmol/L\]) at screening
- Are using lipid-lowering medication at a dose that has not been stable for 90 days prior to screening
- Are using niacin preparations as a lipid lowering medication and bile acid sequestrants within 90 days prior to screening
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
1538 Patients enrolled
Trial Details
Trial ID
NCT01435616
Start Date
November 1 2011
End Date
January 1 2014
Last Update
April 13 2018
Active Locations (167)
Enter a location and click search to find clinical trials sorted by distance.
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, 36207
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.
Mobile, Alabama, United States, 36608
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.
Chandler, Arizona, United States, 85224
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.
Mesa, Arizona, United States, 85206