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

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Drug: Insulin lispro 2 day reservoir in-use; Drug: Insulin lispro 6 day reservoir in-use; Drug: Insulin aspart 6 day reservoir in-use

• Registration Number: NCT01109316
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-19
• Study First Submitted QC: 2010-04-21
• Study First Posted: 2010-04-23
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Results First Submitted: 2012-08-08
• Results First Submitted QC: 2012-09-27
• Results First Posted: 2012-10-30
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-18
• Last Update Posted: 2019-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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%.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Insulin Lispro 2 Day	Insulin lispro 2 day reservoir in-use	-
Insulin Lispro 6 Day	Insulin lispro 6 day reservoir in-use	-
Insulin Aspart 6 Day	Insulin aspart 6 day reservoir in-use	-

Primary Outcome Measures

Name	Time	Method
Mean of Last Five 7-point Self Monitored Blood Glucose (SMBG) Taken on Day 6 for Insulin Lispro 6D and Day 2 for Insulin Lispro 2D and Day 6 for Insulin Aspart 6D Pump Reservoir In-use	8 weeks of each treatment

Secondary Outcome Measures

Name	Time	Method
Change From Baseline to 8 Weeks Endpoint for Each Treatment in Blood Pressure	Baseline, 8 weeks for each treatment
Mean SMBG	8 weeks for each treatment	Mean SMBG for combined periods; all reported SMBG values on days 1-6 for Insulin Lispro 6 Day and Insulin Aspart 6 Day, and days 1-2 for Insulin Lispro 2 Day.
Mean Daily Insulin Dose (Total, Basal, and Bolus)	8 weeks for each treatment
Change From Baseline to 8 Weeks Endpoint for Each Treatment in Hemoglobin A1c (HbA1c) Values	Baseline, 8 weeks for each treatment
Number of Participants Who Achieve or Maintain an HbA1c Less Than or Equal to 6.5% and Less Than 7%	8 weeks for each treatment
Percentage of Participants With Hyperglycemia	8 weeks for each treatment	Hyperglycemia was defined as an event with (1) a measured blood glucose concentration \>250 milligrams per deciliter (mg/dL) (13.9 mmol/L) and ≥3 hours after eating, or (2) a measured blood glucose concentration \>300 mg/dL (16.7 mmol/L) and \<3 hours after eating.
Hyperglycemic Episode Rate Per 30 Days	8 weeks for each treatment	Hyperglycemia was defined as an episode with (1) a measured blood glucose concentration \>250 milligrams per deciliter (mg/dL) (13.9 mmol/L) and ≥3 hours after eating, or (2) a measured blood glucose concentration \>300 mg/dL (16.7 mmol/L) and \<3 hours after eating. Rate is presented as the number of hyperglycemic episodes adjusted for 30 days.
Hypoglycemia Episode Rate Per 30 Days	8 weeks for each treatment	Hypoglycemia was defined as an event which was associated with; 1. reported signs and symptoms of hypoglycemia, and/or; 2. a documented blood glucose (BG) concentration of ≤ 70 mg/dL (3.9 mmol/L). Rate is presented as the number of hypoglycemic episodes adjusted for 30 days.
Percentage of Participants With Pump Complications	8 weeks for each treatment	Overall Pump Complications were any combination of: tubing clogged, kinked, disconnected, pulled out, blood in tubing; too much heat, too much cold, empty reservoir, low battery, occlusion alarm, no delivery alarm; at site - skin abscess, excessive redness, swelling (not nodule), bleeding, bruising; reservoir change (infusion set change reason only); and other. When either a reservoir change or an infusion set change was reported, participants were questioned whether change was early (prior to 6 days for L6D or A6D, or prior to 2 days for L2D). If 'yes', then recorded as premature change.
Pump Complication Rate Per 30 Days	8 weeks for each treatment	Overall Pump Complications were any combination of: tubing clogged, kinked, disconnected, pulled out, blood in tubing; too much heat, too much cold, empty reservoir, low battery, occlusion alarm, no delivery alarm; at site - skin abscess, excessive redness, swelling (not nodule), bleeding, bruising; reservoir change (infusion set change reason only); and other. When either a reservoir change or an infusion set change was reported, participants were questioned whether change was early (prior to 6 days for L6D or A6D, or prior to 2 days for L2D). If 'yes', then recorded as premature change.
Percentage of Participants With Hypoglycemia	8 weeks for each treatment	Hypoglycemia was defined as an event which was associated with; 1. reported signs and symptoms of hypoglycemia, and/or; 2. a documented blood glucose (BG) concentration of ≤ 70 mg/dL (3.9 mmol/L).
Change From Baseline to 8 Weeks Endpoint for Each Treatment in Weight	Baseline, 8 weeks for each treatment

Trial Locations

Locations (1)

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