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

Lilly

Status and phase

Completed

Phase 3

Conditions

Diabetes Mellitus, Type 1

Treatments

Drug: Insulin aspart 6 day reservoir in-use

Drug: Insulin lispro 6 day reservoir in-use

Drug: Insulin lispro 2 day reservoir in-use

Study type

Interventional

Funder types

Industry

Identifiers

NCT01109316

F3Z-MC-IOPV (Other Identifier)

12174

Details and patient eligibility

About

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.

Enrollment

132 patients

Sex

All

Ages

13+ years old

Volunteers

No Healthy Volunteers

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.