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 2 day reservoir in-use; Insulin lispro 6 day reservoir in-use; Insulin aspart 6 day reservoir in-use
Intervention description: Insulin lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.; Insulin lispro 6 Day (L6D) administered by infusion pump for 8 week treatment period.; Insulin aspart 6 Day (A6D) administered by infusion pump for 8 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: None (Open Label)
Enrollment: 132.0
Sex: All
Minimum age: 13 Years
Healthy volunteers: No

Summary:

      This is a 6-sequence, 3-period (8 weeks each), 3-arm, 24-week crossover study. The purpose of
      this study is to provide information on the use of insulin lispro in insulin pumps
      (Continuous Subcutaneous Insulin Infusion [CSII]) compared to insulin aspart over 6 days of
      pump reservoir in-use. The study will also compare the in-use characteristics of insulin
      lispro infused at 6 days with insulin lispro infused at 2 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with type 1 diabetes (World Health Organization criteria) for at least 24
             months.

          -  Treated with continuous subcutaneous insulin infusion therapy for the previous 6
             months.

          -  Mean total daily insulin dose for 3 days prior to screening equal to or less than 46
             units/day using a 300-unit reservoir or less than or equal to 26 units/day using a 180
             unit reservoir.

          -  Baseline body mass index (BMI) less than or equal to 35.0 kg/m^2.

          -  Baseline glycosylated hemoglobin (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 of hypoglycemic coma, seizures, or disorientation in the 12
             months prior to screening.

          -  Have had hypoglycemia unawareness (routinely asymptomatic at blood glucose (BG) less
             than 45 mg/dL) 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.

          -  Patients 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 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 HbA1c methodology.

          -  Are receiving chronic (lasting longer than 14 consecutive days) systemic
             glucocorticoid therapy (excluding topical, intra-articular, intraocular and inhaled
             prescriptions), or have received such therapy within the 4 weeks immediately preceding
             screening.

          -  Have an irregular sleep/wake cycle (for example, patients who sleep during the day and
             work during the night), in the investigator's opinion.

          -  Have 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 an off-label use of an investigational drug or device (other than the
             study drug/device used in this study), or concurrently enrolled in any other type of
             medical research judged not to be scientifically or medically compatible with this
             study.

          -  Have previously completed or withdrawn from this study after having signed the
             informed consent document (ICD).

          -  Are unwilling or unable to comply with the use of a data collection device to directly
             record data from the patient.