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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus, Type 1	Drug: Insulin lispro 2 day reservoir in-use; Drug: Insulin lispro 6 day reservoir in-use; Drug: Insulin aspart 6 day reservoir in-use	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	132 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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 Start Date :	April 2010
Actual Primary Completion Date :	August 2011
Actual Study Completion Date :	August 2011

Arms and Interventions

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Arm	Intervention/treatment
Active Comparator: Insulin Lispro 2 Day	Drug: Insulin lispro 2 day reservoir in-use; Insulin lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.; Other Names: LY275585; Humalog
Experimental: Insulin Lispro 6 Day	Drug: Insulin lispro 6 day reservoir in-use; Insulin lispro 6 Day (L6D) administered by infusion pump for 8 week treatment period.; Other Names: LY275585; Humalog
Active Comparator: Insulin Aspart 6 Day	Drug: Insulin aspart 6 day reservoir in-use; Insulin aspart 6 Day (A6D) administered by infusion pump for 8 week treatment period.

Outcome Measures

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Primary Outcome Measures :

1. 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 [ Time Frame: 8 weeks of each treatment ]

Secondary Outcome Measures :

1. Mean SMBG [ Time Frame: 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.
2. Mean Daily Insulin Dose (Total, Basal, and Bolus) [ Time Frame: 8 weeks for each treatment ]
3. Change From Baseline to 8 Weeks Endpoint for Each Treatment in Hemoglobin A1c (HbA1c) Values [ Time Frame: Baseline, 8 weeks for each treatment ]
4. Number of Participants Who Achieve or Maintain an HbA1c Less Than or Equal to 6.5% and Less Than 7% [ Time Frame: 8 weeks for each treatment ]
5. Percentage of Participants With Hyperglycemia [ Time Frame: 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.
6. Hyperglycemic Episode Rate Per 30 Days [ Time Frame: 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.
7. Percentage of Participants With Pump Complications [ Time Frame: 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.
8. Pump Complication Rate Per 30 Days [ Time Frame: 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.
9. Percentage of Participants With Hypoglycemia [ Time Frame: 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).
10. Hypoglycemia Episode Rate Per 30 Days [ Time Frame: 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.
11. Change From Baseline to 8 Weeks Endpoint for Each Treatment in Weight [ Time Frame: Baseline, 8 weeks for each treatment ]
12. Change From Baseline to 8 Weeks Endpoint for Each Treatment in Blood Pressure [ Time Frame: Baseline, 8 weeks for each treatment ]

Eligibility Criteria

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Ages Eligible for Study:	13 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Locations

United States, California
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, 94520
United States, Colorado
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, 80045
United States, Florida
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, 33021
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, 33401
United States, Idaho
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, 83404
United States, Kansas
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, 66606
United States, New Hampshire
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, 03063
United States, New York
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, 12206
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, 13210
United States, North Carolina
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, 28803
United States, Texas
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, 78731

Sponsors and Collaborators

Eli Lilly and Company

Investigators

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

More Information

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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT01109316 History of Changes
Other Study ID Numbers:	12174; F3Z-MC-IOPV ( Other Identifier: Eli Lilly and Company )
First Posted:	April 23, 2010
Results First Posted:	October 30, 2012
Last Update Posted:	October 30, 2012
Last Verified:	September 2012

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 1; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Insulin, Globin Zinc	Insulin degludec, insulin aspart drug combination; Insulin; Insulin Aspart; Insulin, Long-Acting; Insulin Lispro; Hypoglycemic Agents; Physiological Effects of Drugs