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

Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes Mellitus, Type 1

Intervention: Insulin lispro 2 day reservoir in-use (Drug); Insulin lispro 6 day reservoir in-use (Drug); Insulin aspart 6 day reservoir in-use (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9am - 5pm Eastern (UTC/GMT - 5hrs, EST), Study Director, Affiliation: Eli Lilly and Company

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.

Clinical Details

Official title: An Open-Label, Randomized, Crossover Trial of CSII Reservoir In-use Comparing Insulin Lispro Formulation to Insulin Aspart in Patients With Type 1 Diabetes Mellitus

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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

Secondary outcome:

Mean SMBG

Mean Daily Insulin Dose (Total, Basal, and Bolus)

Change From Baseline to 8 Weeks Endpoint for Each Treatment in Hemoglobin A1c (HbA1c) Values

Number of Participants Who Achieve or Maintain an HbA1c Less Than or Equal to 6.5% and Less Than 7%

Percentage of Participants With Hyperglycemia

Hyperglycemic Episode Rate Per 30 Days

Percentage of Participants With Pump Complications

Pump Complication Rate Per 30 Days

Percentage of Participants With Hypoglycemia

Hypoglycemia Episode Rate Per 30 Days

Change From Baseline to 8 Weeks Endpoint for Each Treatment in Weight

Change From Baseline to 8 Weeks Endpoint for Each Treatment in Blood Pressure

Eligibility

Minimum age: 13 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

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 94520, 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 80045, 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 33021, 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 33401, 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 83404, 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 66606, 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 03063, 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 12206, 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 13210, 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 28803, 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 78731, United States

Additional Information

Starting date: April 2010
Last updated: September 27, 2012

Page last updated: August 23, 2015

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