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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01109316
First received: April 19, 2010
Last updated: September 27, 2012
Last verified: September 2012
  Purpose

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 Intervention 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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean SMBG [ Time Frame: 8 weeks for each treatment ] [ Designated as safety issue: No ]
    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) [ Time Frame: 8 weeks for each treatment ] [ Designated as safety issue: No ]
  • Change From Baseline to 8 Weeks Endpoint for Each Treatment in Hemoglobin A1c (HbA1c) Values [ Time Frame: Baseline, 8 weeks for each treatment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Percentage of Participants With Hyperglycemia [ Time Frame: 8 weeks for each treatment ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 8 weeks for each treatment ] [ Designated as safety issue: Yes ]
    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.

  • Percentage of Participants With Pump Complications [ Time Frame: 8 weeks for each treatment ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 8 weeks for each treatment ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 8 weeks for each treatment ] [ Designated as safety issue: Yes ]

    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).

  • Hypoglycemia Episode Rate Per 30 Days [ Time Frame: 8 weeks for each treatment ] [ Designated as safety issue: Yes ]

    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.

  • Change From Baseline to 8 Weeks Endpoint for Each Treatment in Weight [ Time Frame: Baseline, 8 weeks for each treatment ] [ Designated as safety issue: Yes ]
  • Change From Baseline to 8 Weeks Endpoint for Each Treatment in Blood Pressure [ Time Frame: Baseline, 8 weeks for each treatment ] [ Designated as safety issue: Yes ]

Enrollment: 132
Study Start Date: April 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01109316

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

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01109316     History of Changes
Other Study ID Numbers: 12174, F3Z-MC-IOPV
Study First Received: April 19, 2010
Results First Received: August 8, 2012
Last Updated: September 27, 2012
Health Authority: United States: Food and Drug Administration

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
Insulin Aspart
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014