Insulin Lispro 6 Days Versus Insulin Aspart 6 Days in Pump Use

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Insulin; Insulin Aspart; Insulin degludec, insulin aspart drug combination; Insulin Lispro; Insulin, Globin Zinc; Insulin, Long-Acting

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.