A Study of LY2605541 in Participants With Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: LY2605541; Insulin Lispro
Intervention description: All participants will be administering insulin lispro SQ as their pre-meal insulin during the course of the trial.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Lispro
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 212.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility 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