Insulin Lispro 6 Days Versus Insulin Aspart 6 Days in Pump Use
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Insulin Lispro 6 Day (6D); Insulin Aspart 6 Day (6D)
Intervention description: Administered by infusion pump for 12 week treatment period; Administered by infusion pump for 12 week treatment period
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin Lispro
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 133.0
Sex: All
Minimum age: 13 Years
Healthy volunteers: No

Summary:

      Patients will continue to use their current insulin pump for this study. Patients will
      receive insulin lispro and insulin aspart during this study. One medication will be taken for
      12 weeks and then the other medication for 12 weeks. Neither the patient nor the study doctor
      will know which medication is being taken at any time. The order in which the two medications
      are taken will be determined by chance.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with type 1 diabetes (World Health Organization criteria) for at least 24
             months

          -  Treated with continuous subcutaneous insulin infusion (CSII) therapy for the previous
             6 months

          -  Mean total daily insulin dose for 3 days prior to screening less than or equal to 46
             units/day if using a 300-Unit reservoir, less than or equal to 30 units/day if using a
             200 unit reservoir, or less than or equal to 26 units/day if using a 180 unit
             reservoir

          -  Baseline body mass index (BMI) less than or equal to 35.0 kilograms per meter squared
             (kg/m2)

          -  Baseline glycated hemoglobin A1c (HbA1c) 5% to 9%

        Exclusion Criteria:

          -  Impaired renal function (serum creatinine greater than or equal to 2.0 milligrams per
             deciliter (mg/dL))

          -  Legal blindness

          -  Have had any episode in the 12 months prior to screening of hypoglycemic coma,
             seizures, or disorientation

          -  Have had hypoglycemia unawareness (routinely asymptomatic at blood glucose less than
             45 mg/dL [2.5 millimoles per liter (mmol/L)]) in the 12 months prior to screening.

          -  Have had any emergency room visits or hospitalizations due to poor glucose control in
             the 12 months prior to screening.

          -  Have had a pump-related infusion site abscess in the 12 months prior to screening.

          -  Have had multiple, clinically significant occlusions as judged by the investigator.

          -  Have had any infection with Staphylococcus aureus in the past 5 years

          -  Have one of the following concomitant diseases: presence of clinically significant
             hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease, or any
             other serious disease considered by the investigator to be exclusionary.

          -  Participants with malignancy other than basal cell or squamous cell skin cancer who
             have not yet been treated, are currently being treated, or who were diagnosed less
             than 5 years ago.

          -  Have had a blood transfusion or severe blood loss within the 3 months prior to
             screening or have known hemoglobinopathy, hemolytic or sickle cell anemia, or any
             other traits of hemoglobin abnormalities known to interfere with HbA1c methodology.

          -  Are receiving chronic systemic glucocorticoid therapy, or have received such therapy
             within the 4 weeks preceding screening.

          -  Have an irregular sleep/wake cycle in the investigator's opinion.

          -  Have a known hypersensitivity or allergy to any of the study insulins or their
             excipients

          -  Are breastfeeding or pregnant, or intend to become pregnant during the course of the
             study, or are sexually active women of childbearing potential not actively practicing
             birth control by a method determined by the investigator to be medically acceptable.

          -  Are currently enrolled in, or discontinued within the last 30 days from a clinical
             trial involving off-label use of an investigational drug or device, or currently
             enrolled in any other type of medical research not to be scientifically or medically
             compatible with this study.

          -  Are unwilling or unable to comply with the use of a data collection device to directly
             record data from the participant.