A Study of LY2605541 in Participants With Type 1 Diabetes Mellitus

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

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 A1c (HbA1c). Participants will be treated for up to 36 weeks with LY2605541 (one 12-week Lead-in period and two 12-week Randomization periods) and will participate in a total of 42 weeks of total study enrollment, including a 2-week Screening period and a 4-week Follow-up period.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Insulin; Insulin Lispro; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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