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

NCT ID: NCT01109316

Last Updated: 2019-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2011-08-31

Brief 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.

Conditions

Diabetes Mellitus, Type 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Insulin Lispro 2 Day

Group Type: ACTIVE_COMPARATOR

Insulin lispro 2 day reservoir in-use

Intervention Type: DRUG

Insulin lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.

Insulin Lispro 6 Day

Group Type: EXPERIMENTAL

Insulin lispro 6 day reservoir in-use

Intervention Type: DRUG

Insulin lispro 6 Day (L6D) administered by infusion pump for 8 week treatment period.

Insulin Aspart 6 Day

Group Type: ACTIVE_COMPARATOR

Insulin aspart 6 day reservoir in-use

Intervention Type: DRUG

Insulin aspart 6 Day (A6D) administered by infusion pump for 8 week treatment period.

Interventions

Insulin lispro 2 day reservoir in-use

Insulin lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.

Intervention Type: DRUG

Insulin lispro 6 day reservoir in-use

Insulin lispro 6 Day (L6D) administered by infusion pump for 8 week treatment period.

Intervention Type: DRUG

Insulin aspart 6 day reservoir in-use

Insulin aspart 6 Day (A6D) administered by infusion pump for 8 week treatment period.

Intervention Type: DRUG

Other Intervention Names

LY275585; Humalog; LY275585; Humalog

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.

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9am - 5pm Eastern (UTC/GMT - 5hrs, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Concord, California, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Aurora, Colorado, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Hollywood, Florida, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

West Palm Beach, Florida, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Idaho Falls, Idaho, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Topeka, Kansas, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Nashua, New Hampshire, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Albany, New York, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Syracuse, New York, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Asheville, North Carolina, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Austin, Texas, United States

Countries

United States

Other Identifiers

F3Z-MC-IOPV

Identifier Type: OTHER

Identifier Source: secondary_id

12174

Identifier Type: -

Identifier Source: org_study_id