Clinical trial NCT01134107 (phase 3, status: completed)
Conditions: diabetes mellitus, type 1
ICD codes: E10.65, E10.9, E10.21, E10.36, E10.41, E10.42, E10.44
Drugs: insulin lispro 6 day (6d), insulin aspart 6 day (6d)
SMILES: [Na+].[Na+].[O-]P([O-])(F)=O, [Na+].[Na+].[O-]P([O-])(F)=O
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.